ThruPort Systems Edwards Protection Cannulae. Product Guides

Transcription

1 ThruPort Systems Edwards Protection Cannulae Product Guides

2 table of contents ThruPort Systems and Edwards Protection Cannulae Table of Contents ThruPort Systems Disposables... 1 Reusables... 2 Edwards Protection Cannulae Arterial Cannulae... 3 Venous Cannulae... 4 Femoral Cannulae... 5 Cardioplegia Cannulae... 6 Blood Management... 7 Index ThruPort Systems... 8 Edwards Protection Cannulae... 9 Products by Model AR07092, rev date 01/2012 i

3 table of contents For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events. Edwards, Edwards Lifesciences, the stylized E logo, Edwards Protection Cannulae, and ThruPort are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR07092, rev date 01/2012 ii

4 ThruPort Systems ThruPort Systems ThruPort Systems Disposables Reusables MIVS Redefined > THRUPORT SYSTEMS > TECHNOLOGY > TRAINING > SUPPORT AR07035, rev date 11/2011

5 1. Disposables 1. Disposables Edwards Lifesciences ThruPort systems provide the broadest range of products for minimal incision valve surgery. Through peripheral cannulation, intra-aortic occlusion, and specialized techniques for myocardial protection, ThruPort systems offers excellent visualization of cardiac structures through a virtually bloodless, unobstructed operative field so surgeons can repair or replace the valve through the smallest incision possible*. *When compared to median sternotomy AR07035, rev date 11/2011

6 Retrograde Cardioplegia ThruPort systems ProPlege peripheral retrograde cardioplegia device is indicated for occlusion of the coronary sinus, delivery of cardioplegic solution and monitoring of coronary sinus pressure during cardiopulmonary bypass surgery. ProPlege Peripheral Retrograde Cardioplegia Device Occludes coronary sinus, delivers retrograde crystalloid or blood cardioplegia into the coronary sinus, and monitors coronary sinus pressure Occlusive balloon and large lumen allow delivery of cardioplegia at low pressures Articulating, steerable tip with ergonomic handle facilitates placement into the sinus 1 unit per case 22.2 inch (59 cm) effective length 32.3 inch (82 cm) overall length PR9 9 Fr. (3.0 mm) catheter 11 Fr. (3.7 mm) introducer 2 ml and 30 ml syringes Hemostasis valve adapter AR08047, rev date 06/

7 Vent Catheter ThruPort systems EndoVent pulmonary catheter assists in decompressing the heart and maintaining a dry operative field via drainage from the pulmonary artery. EndoVent Pulmonary Catheter Percutaneous insertion via internal jugular vein provides an unobstructed operative field Thin wall, 8.3 Fr design delivers high flow rates to ensure adequate venting in all sizes of patients Contamination guard system facilitates sterile catheter repositioning Pre-shaped catheter and flow directed balloon enable easy placement into the pulmonary artery 1 unit per case 25.5 inch (65 cm) overall length EV 8.3 Fr. (2.8 mm) catheter 9 Fr. (3.0 mm) introducer 1.5 ml syringe 1.2 AR08047, rev date 06/2012

8 Aortic Occlusion ThruPort systems provides two devices that work to occlude the ascending aorta, vent the aortic root, monitor aortic root pressure and deliver antegrade cardioplegia solution to arrest the heart. These products include the IntraClude intra-aortic occlusion device and the EndoClamp aortic catheter. IntraClude Intra-aortic Occlusion Device A 9 Fr, triple lumen catheter with an elastomeric balloon at its tip for occluding the ascending aorta The large central lumen of the catheter delivers antegrade cardioplegia and vents the aortic root Monitors aortic root and balloon pressures Designed for femoral approach and used with the EndoReturn arterial cannula (ER21B, ER23B) or Introducer Sheath (IS19A) 1 unit per case 39.3 inch (100 cm) overall length ICF inch (200 cm) guidewire 1-35 ml syringe Y-connector Red and blue pressure lines Suture loop / box clamp Close up of tip AR08047, rev date 06/

9 Aortic Occlusion EndoClamp Aortic Catheter A 10.5 Fr wire-wound, triple lumen catheter with an elastomeric balloon at its tip for occluding the ascending aorta The large central lumen of the catheter delivers antegrade cardioplegia and vents the aortic root Monitors aortic root and balloon pressures Designed for aortic approach and used with the EndoDirect arterial cannula (ED24A) 1 unit per case 25.5 inch (65 cm) overall length EC65 Vacuum relief valve 2-35 ml syringes Y-connector Red and blue pressure lines Close up of tip 1.4 AR08047, rev date 06/2012

10 Arterial Cannulae ThruPort systems arterial cannulae are intended to deliver oxygenated blood for cardiopulmonary bypass surgery. 120 Arterial: Pressure Drop vs. Flow* ER21B EndoReturn Arterial Cannula Wire-wound, femoral arterial cannula includes introducer, inch guidewire (not shown), and connector hub The side-arm and rotating hemostasis valve allow for passage of the 100 cm IntraClude intra-aortic occlusion device (ICF100), providing for a single site for gentle occlusion of the ascending aorta, aortic root venting, delivery of antegrade cardioplegia and monitoring aortic root pressure Pressure Drop (mmhg) ER23B Flow Rate (L/min) * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. 1 unit per case 3.7 inch (9.4 cm) effective length ER21B ER23B 21 Fr. (7.0 mm) inch (100 cm) guidewire Introducer Connector hub 23 Fr. (7.6 mm) inch (100 cm) guidewire Introducer Connector hub AR08047, rev date 06/

11 Arterial Cannulae EndoDirect Arterial Cannula Arterial: Pressure Drop vs. Flow* Enables 24 Fr direct aortic cannulation and antegrade flow through a minimal incision approach AutoIncisor introducer facilitates easy, single-step aortotomy The side arm and rotating hemostasis valve allow for passage of the 65 cm EndoClamp aortic catheter (EC65), providing for a single site for gentle occlusion of the ascending aorta, aortic root venting, delivery of antegrade cardioplegia and monitoring aortic root pressure 1 unit per case 8.1 inch (20.6 cm) effective length Pressure Drop (mmhg) Flow Rate (L/min) ED24A with EC65 inflated ED24A with EC65 deflated ED24A * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. ED24A 24 Fr. (8.0 mm) AutoIncisor introducer 2 units tourniquet style tubing 1.6 X AR08047, rev date 06/2012

12 Arterial Cannulae Arterial Cannula Arterial: Pressure Drop vs. Flow* For femoral arterial cannulation Avoids high pressure For use on small femoral arteries 1 unit per case Pressure Drop (mmhg) AC Flow Rate (L/min) * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. 3.7 inch (9.4 cm) effective length AC19 19 Fr. (6.3 mm) inch (100 cm) guidewire Introducer Connector hub AR08047, rev date 06/

13 Arterial Cannulae Introducer Sheath For hemostatic introduction and removal of vascular catheters 19 Fr. cannula serves as separate introducer sheath for the IntraClude intra-aortic occlusion device (ICF100) Rotating hemostasis valve allows for passage of the 100 cm IntraClude intra-aortic occlusion device (ICF100) For use when bilateral cannulation is preferred 1 unit per case 3.7 inch (9.4 cm) effective length IS19A 19 Fr. (6.3 mm) inch (100 cm) guidewire Introducer 1.8 AR08047, rev date 06/2012

14 Arterial Cannulae Direct Arterial Cannula Arterial: Pressure Drop vs. Flow* Wire-wound, thin wall design provides for excellent flow characteristics Low profile design provides clear operative field ideal for minimal incision approaches AutoIncisor introducer facilitates easy, single-step aortotomy Additional options available with a moveable suture ring 1 unit per case Angled Tip 9.01 inch (22.9 cm) effective length Pressure Drop (mmhg) Flow Rate (L/min) SS23S SS23A * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. SS23A SS23AM 23 Fr. (7.6 mm) AutoIncisor introducer 23 Fr. (7.6 mm) AutoIncisor introducer Moveable suture ring Straight Tip 8.81 inch (22.4 cm) effective length SS23S SS23SM 23 Fr. (7.6 mm) AutoIncisor introducer 23 Fr. (7.6 mm) AutoIncisor introducer Moveable suture ring AR08047, rev date 06/

15 Arterial Cannulae OptiSite Arterial Cannula The OptiSite arterial cannula incorporates easy to use and proprietary ultra-thin wall technology to provide clinicians with the flexibility of a variety of safe cannulation techniques and sites, such as: aorta, femoral, axillary and subclavian. Blunt introducer tip allows safe insertion Lock feature reduces push back of the introducer during insertion Vent cap reduces back bleed during aortic cannulation Depth markings aid in placement Pressure Drop (mmhg) Arterial: Pressure Drop vs. Flow* Arterial: Pressure Drop vs. Flow* Flow Rate (L/min) OPTI16 OPTI OPTI18 OPTI20 OPTI22 * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. 1 unit per case 5.9 inch (15 cm) effective length 8.18 inch (20.8 cm) overall length OPTI16 OPTI18 OPTI20 OPTI22 16 Fr. (5.3 mm) Blunt tip introducer Guidewire Vented 3/8 inch connector 18 Fr. (6.0 mm) Blunt tip introducer Guidewire Vented 3/8 inch connector 20 Fr. (6.7 mm) Blunt tip introducer Guidewire Vented 3/8 inch connector 22 Fr. (7.3 mm) Blunt tip introducer Guidewire Vented 3/8 inch connector 1.10 AR08047, rev date 06/2012

16 Venous Cannulae ThruPort systems QuickDraw venous cannulae serve to drain non-oxygenated blood from the vena cava and/or right atrium during cardiopulmonary bypass surgery. QuickDraw Venous Cannula 160 Venous: Pressure Drop vs. Flow* Thin wall, wire-wound design offers excellent flow characteristics Large, interspaced drainage holes allow for consistent, uninterrupted venous drainage Compatible with percutaneous approaches Smooth dilator-to-cannula transition facilitates easy placement 1 unit per case * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques inch (65 cm) effective length Pressure Drop (mmhg) Flow Rate (L/min) QD22 QD25 QD22 QD25 22 Fr. (7.3 mm) inch (9.5 mm) barbed connector Introducer inch (180 cm) guidewire Percutaneous insertion kit 5 ml syringe 25 Fr. (8.3 mm) inch (9.5 mm) barbed connector Introducer inch (180 cm) guidewire Percutaneous insertion kit 5 ml syringe AR08047, rev date 06/

17 Accessory Devices ThruPort systems product portfolio includes additional disposable devices to complement your minimal incision surgical technique. PeriVue Soft Tissue Retractor Disposable soft tissue retractor is designed specificially for retraction at intercostal incisions Provides 360 degree coverage for excellent visibility and access Enables access to the surgical site without need for conventional rib retraction Low profile for unimpaired instrument access to the incision PVS PVM PVL 6.0 cm ring diameter 7.5 cm ring diameter 9.0 cm ring diameter Knot Pusher Knot pusher simplifies extracorporeal knot tying of valve sutures KP inch (33 cm) length 1.12 AR08047, rev date 06/2012

18 Accessory Devices Valve Placement Pack Valve probe has a soft, atraumatic tip for testing mechanical prosthetic valve leaflet motion Valve seater has a soft, silicone rubber tip designed to seat mechanical prosthetic valves Knot pusher simplifies extracorporeal knot tying of valve sutures VPP 12.9 inch (33 cm) length Valve Probe Valve Seater Knot pusher Close up of tips AR08047, rev date 06/

19 For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, AutoIncisor, EndoClamp, EndoDirect, EndoPlege, EndoReturn, EndoVent, IntraClude, OptiSite, PeriVue, ProPlege, QuickDraw, and ThruPort are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR08047, rev date 06/

20 2. Reusables Edwards Lifesciences ThruPort systems offers specialized long-shafted instrumentation and retractors to enable minimal incision valve surgery. This portfolio of products enable access to the valve through the smallest incision possible*. 2. Reusables *When compared to median sternotomy AR07035, rev date 11/2011

21 RETRACTION ThruPort systems Ergonic minimal incision retractors are designed to better facilitate minimal incision valve surgery (MIVS) by improving visualization of the internal and external cardiac structures. The intuitive design offers greater flexibility and ease of use. Ergonic Atrial Retractor The Ergonic atrial retractor improves mitral valve exposure by providing retraction of the anterior wall of the right atrium. The product features a tripod base for stability and 360 movement for optimal positioning. The articulating blade allows customized retraction based on patient anatomy and surgeon preference. Unique tripod base design for greater stability when placed Easy and secure locking system to prevent rotation once placed 360º rotation allows for free range of movement Variety of interchangeable blades tailored to fit varying patient anatomy Articulating blades offer greater exposure and visualization with an expanded range of motion from -10º to +30º AR07452, rev date 02/

22 RETRACTION Ergonic Atrial Retractor with Articulating Blades ERGAR1000 Includes three articulating blades: 35 mm x 40 mm 35 mm x 50 mm 45 mm x 50 mm Ergonic Atrial Retractor Forceps ERGAR0224 Atrial retractor forceps Additional Articulating Blades ERGAR mm x 30 mm ERGAR mm x 60 mm ERGAR mm x 70 mm 2.2 AR07452, rev date 02/2012

23 RETRACTION Ergonic Rib Retractor System The Ergonic rib retractor system provides intercostal retraction for aortic valve, mitral valve and other minimal incision cardiac procedures. The low profile design helps maximize usable surgical space and the retractor features a large variety of blades and accessories to meet different surgical needs. Quick and easy to assemble Accommodates multiple accessories Low profile design Durable construction Multiple blade sizes and configurations tailored to fit varying patient anatomy AR07452, rev date 02/

24 RETRACTION Ergonic Rib Retractor System ERGIR0100 Includes: Standard blade, 36 mm x 30 mm Standard blade, 36 mm x 40 mm Standard blade, 36 mm x 50 mm 3D arm, 30 mm Wire blade, 160 mm Ergonic Standard Rib Retractor Blades ERGIR0130 ERGIR0140 ERGIR0150 ERGIR0230 ERGIR0240 ERGIR0250 ERGIR0330 ERGIR0340 ERGIR mm x 30 mm 28 mm x 40 mm 28 mm x 50 mm 36 mm x 30 mm 36 mm x 40 mm 36 mm x 50 mm 44 mm x 30 mm 44 mm x 40 mm 44 mm x 50 mm Ergonic Reversed Rib Retractor Blades ERGIR1130 ERGIR1140 ERGIR1150 ERGIR1230 ERGIR1240 ERGIR1250 ERGIR1330 ERGIR1340 ERGIR mm x 30 mm 28 mm x 40 mm 28 mm x 50 mm 36 mm x 30 mm 36 mm x 40 mm 36 mm x 50 mm 44 mm x 30 mm 44 mm x 40 mm 44 mm x 50 mm 2.4 AR07452, rev date 02/2012

25 RETRACTION Ergonic Rib Retractor Accessories ERGIR2030 3D arm, 30 mm ERGIR2050 3D arm, 50 mm ERGIR2090 3D arm, 90 angled ERGIR2099 3D extension, 105 mm ERGIR2116 Wire blade, 160 mm AR07452, rev date 02/

26 RETRACTION Ergonic Rib Retractor Accessories (continued) ERGIR2226 Malleable spatula 260 mm ERGIR2301 C-shaped stabilizer ERGIR2302 U-shaped stabilizer ERGIR2430 Additional blade ERGIR2505 Attachment bracket 2.6 AR07452, rev date 02/2012

27 LONG SHAFTED INSTRUMENTS ThruPort systems Ergonic long shafted instruments are designed to facilitate MIVS by offering an ergonomic handle for greater comfort during the procedure. The handle is customized for ease of use with a variety of configurations and greater versatility. Available in 30 cm, 36 cm and 43 cm total lengths Flush port for easy cleaning 3.5 mm and 5 mm shaft diameters available Ergonomic handle design Side view Top view AR07452, rev date 02/

28 LONG SHAFTED INSTRUMENTS Ergonic Forceps The Ergonic forceps are designed for grasping and manipulating cardiac structures during MIVS. Available in multiple configurations to meet a wide variety of surgical needs: Length: 30 cm for aortic valve procedures, 36 cm for mitral valve procedures and 43 cm for large patients or robotic procedures Shaft diameter: 3.5 mm and 5 mm Shape: Curved, straight and angled Grasping configuration: Wide, standard and narrow Ergonic Double Acting DeBakey Forceps with Straight Tip ERGF mm shaft diameter 30 cm length ERGF mm shaft diameter 36 cm length Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip ERGF mm shaft diameter 30 cm length ERGF mm shaft diameter 30 cm length ERGF mm shaft diameter 36 cm length Ergonic Double Acting Resano Forceps with Straight Tip ERGF mm shaft diameter 30 cm length ERGF02530 ERGF mm shaft diameter 30 cm length 5.0 mm shaft diameter 36 cm length 2.8 AR07452, rev date 02/2012

29 LONG SHAFTED INSTRUMENTS Ergonic Single Acting DeBakey Forceps with Straight Tip ERGF03330 ERGF mm shaft diameter 30 cm length 5.0 mm shaft diameter 36 cm length Ergonic Double Acting DeBakey Forceps with 45 Curved Tip ERGF mm shaft diameter 30 cm length ERGF mm shaft diameter 36 cm length Ergonic Single Acting DeBakey Forceps with 45 Angled Tip ERGF mm shaft diameter 30 cm length ERGF mm shaft diameter 36 cm length ERGF mm shaft diameter 30 cm length Ergonic Double Acting DeBakey Forceps with Slightly Curved Tip ERGF07330 ERGF mm shaft diameter 30 cm length 5.0 mm shaft diameter 36 cm length Ergonic Double Acting DeBakey Forceps with 75 Curved Tip ERGF mm shaft diameter 36 cm length AR07452, rev date 02/

30 LONG SHAFTED INSTRUMENTS Ergonic Scissors The Ergonic scissors are designed for cutting soft tissue during MIVS. Available in multiple configurations to meet a wide variety of surgical needs: Length: 30 cm for aortic valve procedures, 36 cm for mitral valve procedures and 43 cm for large patients or robotic procedure Shaft diameter: 3.5 mm and 5 mm Shape: Curved (lightly, standard, strongly) and angled (30, 45, 90 and 125 ) Ergonic Double Acting Scissors Lightly Curved ERGS mm shaft diameter 30 cm length ERGS mm shaft diameter 36 cm length Ergonic Double Acting Scissors Standard Curved ERGS mm shaft diameter 30 cm length ERGS01530 ERGS01536 ERGS mm shaft diameter 30 cm length 5.0 mm shaft diameter 36 cm length 5.0 mm shaft diameter 43 cm length 2.10 AR07452, rev date 02/2012

31 LONG SHAFTED INSTRUMENTS Ergonic Double Acting Scissors Strongly Curved ERGS02330 ERGS02530 ERGS mm shaft diameter 30 cm length 5.0 mm shaft diameter 30 cm length 5.0 mm shaft diameter 36 cm length ERGS mm shaft diameter 43 cm length Ergonic Single Acting Scissors Lightly Curved ERGS07330 ERGS mm shaft diameter 30 cm length 5.0 mm shaft diameter 36 cm length Ergonic Single Acting Scissors Standard Curved ERGS mm shaft diameter 30 cm length Ergonic Single Acting Scissors 30 Angled ERGS mm shaft diameter 30 cm length ERGS mm shaft diameter 36 cm length AR07452, rev date 02/

32 LONG SHAFTED INSTRUMENTS Ergonic Single Acting Scissors 45 Angled ERGS03530 ERGS mm shaft diameter 30 cm length 5.0 mm shaft diameter 36 cm length ERGS mm shaft diameter 30 cm length Ergonic Single Acting Scissors 90 Angled ERGS04330 ERGS mm shaft diameter 30 cm length 5.0 mm shaft diameter 36 cm length Ergonic Single Acting Scissors 125 Angled ERGS mm shaft diameter 30 cm length 2.12 AR07452, rev date 02/2012

33 LONG SHAFTED INSTRUMENTS Ergonic Needle Drivers The Ergonic needle drivers are designed for grasping needles during use in MIVS. The product features two-tone handles for easy identification on the surgical field. Available in multiple configurations to meet a wide variety of surgical needs: Length: 30 cm for aortic valve procedures, 36 cm for mitral valve procedures and 43 cm for large patients or robotic procedures Shaft diameter: 3.5 mm and 5 mm Tip configuration: Curved and straight Inserts: Tungsten carbide, diamonite Ergonic Locking Needle Driver with Curved Tip ERGN10330 ERGN10336 ERGN02536 ERGN02543 ERGN00536 ERGN09330 ERGN07330 ERGN08330 Tungsten carbide 3.5 mm shaft diameter 30 cm length Tungsten carbide 3.5 mm shaft diameter 36 cm length Tungsten carbide 5.0 mm shaft diameter 36 cm length Tungsten carbide 5.0 mm shaft diameter 43 cm length Diamonite 5.0 mm shaft diameter 36 cm length Diamonite 3.5 mm shaft diameter 30 cm length Small tip, diamonite 3.5 mm shaft diameter 30 cm length Small tip, tungsten carbide 3.5 mm shaft diameter 30 cm length AR07452, rev date 02/

34 LONG SHAFTED INSTRUMENTS Ergonic Locking Needle Driver with Straight Tip ERGN03330 ERGN03536 Tungsten carbide 3.5 mm shaft diameter 30 cm length Tungsten carbide 5.0 mm shaft diameter 36 cm length ERGN01536 Diamonite 5.0 mm shaft diameter 36 cm length Ergonic Locking Needle Driver with Narrow Straight Tip ERGN04330 Tungsten carbide 3.5 mm shaft diameter 30 cm length ERGN04536 Tungsten carbide 5.0 mm shaft diameter 36 cm length 2.14 AR07452, rev date 02/2012

35 ACCESSORIES ThruPort systems Ergonic minimal incision instrumentation accessories are designed to facilitate MIVS by offering a full portfolio of long shafted tools for a variety of surgical needs, from simple to complex procedures. Ergonic Hooks The Ergonic cardiac surgery hooks are designed to retract valves and cardiac structures during MIVS. Available in multiple configurations to meet a wide variety of surgical needs: Configuration: 30 cm, adjustable length and sliding handle Tip configuration: Straight, round, 45 and 90 Ergonic Cardiac Surgery Hook with Straight Tip ERGH00100 ERGH00130 Adjustable handle 29 cm 36 cm length Standard handle 30 cm length Ergonic Cardiac Surgery Hook with Round Tip ERGH00200 ERGH00230 Adjustable handle 29 cm 36 cm length Standard handle 30 cm length Ergonic Cardiac Surgery Hook with 45 Angled Tip ERGH00400 ERGH00430 Adjustable handle 29 cm 36 cm length Standard handle 30 cm length Ergonic Cardiac Surgery Hook with 90 Angled Tip ERGH00700 ERGH00730 Adjustable handle 29 cm 36 cm length Standard handle 30 cm length AR07452, rev date 02/

36 ACCESSORIES Ergonic Cardiac Surgery Hook Sliding Handle ERGH cm length Ergonic Suture Catcher The Ergonic suture catcher is designed to effectively snare and exteriorize suture during MIVS. ERGC cm length 2.16 AR07452, rev date 02/2012

37 ACCESSORIES Ergonic Blade Holder The Ergonic blade holders are designed to hold disposable scalpel blades during MIVS. Handle configuration: Standard and adjustable length Type: Beaver blades or carbon blades Ergonic Blade Holder for Carbon Blades ERGB00000 ERGB00033 Adjustable handle 29 cm 36 cm length Standard handle 33 cm length Ergonic Blade Holder for Beaver Blades ERGB00133 Standard handle 33 cm length AR07452, rev date 02/

38 ACCESSORIES Ergonic Aortic Valve Rongeurs The Ergonic rongeurs are designed to grasp and remove hard materials, such as calcific plaque, from cardiac structures during MIVS. Tip configuration: Straight, up-biting and down-biting ERGR00030 Straight tip 30 cm length ERGR00130 Up-biting tip 30 cm length ERGR00230 Down-biting tip 30 cm length 2.18 AR07452, rev date 02/2012

39 ACCESSORIES Ergonic Magnetic Needle Retriever The Ergonic magnetic needle retriever is designed to capture and remove needles from the surgical site. ERGM01000 ERGM01028 Adjustable handle 29 cm 36 cm length Standard handle 28 cm length Ergonic Chordae Suture Ruler The Ergonic chordae suture ruler is designed to measure chordae length, so pre-measured chordae suture loops can be created. ERGC cm length AR07452, rev date 02/

40 ACCESSORIES Ergonic Suture Ring The Ergonic suture ring is designed to facilitate MIVS by allowing sutures to be organized effectively in the surgical field. ERGR40000 Without cleaning luer ERGR40001 With cleaning luer For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, Ergonic, and ThruPort are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR07452, rev date 02/

41 Edwards Protection Cannulae Edwards Protection Cannulae Edwards Protection Cannulae Arterial Cannulae Venous Cannulae Femoral Cannulae Cardioplegia Cannulae Blood Management AR07035, rev date 11/2011

42 3. Arterial Cannulae 3. Arterial Cannulae Edwards Lifesciences offers a full range of arterial cannulae. A wide selection of dispersion tip and open tip cannulae accommodate a variety of patients, clinical requirements, and surgical approaches. Edwards arterial cannulae are specifically designed to help you protect your patients during on-pump cardiac surgery by minimizing trauma to the aorta and by enabling less invasive surgical techniques. AR07035, rev date 11/2011

43 Arterial Cannulae OptiSite Arterial Cannula The OptiSite arterial cannulae incorporates easy-to-use and proprietary ultra-thin wall technology to provide a variety of safe cannulation site options designed to accommodate multiple surgical techniques and clinician preferences. Indicated for cannulation in various arterial sites such as aorta, femoral, axillary and subclavian Blunt introducer tip allows for safe insertion Proprietary locking introducer reduces retraction during insertion Vent cap reduces back bleed during aortic cannulation Depth markings to aid in placement Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 16 Fr. 18 Fr Fr Fr Flow Rate (L/min), H 2 O at Room Temperature 1 unit per case Blunt Tip Introducer with Guidewire 15 cm effective length 20.8 cm overall length Vented 3/8 inch connector OPTI16 16 Fr. (5.3 mm) OPTI18 18 Fr. (6.0 mm) OPTI20 20 Fr. (6.7 mm) OPTI22 22 Fr. (7.3 mm) AR07316, rev date 01/

44 Arterial Cannulae EMBOL-X Glide Protection System 200 Pressure Drop vs. Flow Rate The EMBOL-X Glide protection system is the only device that combines a low-trauma outflow path with advanced filter technology. With detectable particulates released in virtually every cardiac surgery, 1-6 the prevalence and potential dangers of emboli have been well documented. 2,6,7 Research has also demonstrated the safety and benefits of intra-aortic filtration, including reductions in certain adverse events and end-organ damage, which could potentially shorten the length of hospital stays. 2,8,9 Pressure Drop (mmhg) Fr Flow Rate (L/min), H 2 O at Room Temperature Dispersion tip that allows a low trauma outflow path Advanced filter technology demonstrated to provide safe and effective emboli capture and reduction of adverse neurologic and end organ events Integrated into a conventional cannula design for ease-of-use Available in kits or as individual components 1 unit per case Cannula Only 11 inch (28 cm) overall length EXGF24D 24 Fr. (8.0 mm) Filter Only EXXSD EXSSD EXMMD EXLLD EXXLD Extra small filter, ID mm Small filter, ID mm Medium filter, ID mm Large filter, ID mm Extra large filter, ID mm 3.2 AR07316, rev date 01/2012

45 Arterial Cannulae EMBOL-X Glide Protection System (continued) Single Filter Kits 11 inch (28 cm) overall length EXGF24XSD (1) cannula + (1) extra small filter EXGF24SSD (1) cannula + (1) small filter EXGF24MMD (1) cannula + (1) medium filter EXGF24LLD (1) cannula + (1) large filter EXGF24XLD (1) cannula + (1) extra large filter + Dual Filter Kits 11 inch (28 cm) overall length EXGF24XS2D (1) cannula + (2) extra small filter EXGF24SS2D (1) cannula + (2) small filter EXGF24MM2D (1) cannula + (2) medium filter EXGF24LL2D (1) cannula + (2) large filter EXGF24XL2D (1) cannula + (2) extra large filter + + AR07316, rev date 01/

46 Arterial Cannulae EMBOL-X Glide Protection System (continued) Aortic Sizers CA40101 EMBOL-X aortic sizer kit EMBOL-X Histology Tube Kit HI001 HI002 Small histology tube kit Large histology tube kit 1. Barbut D, Hinton RB, Szatrowski TP, et al. Cerebral emboli detected during bypass surgery are associated with clamp removal. Stroke. Dec 1994;25(12): Barbut D, Lo YW, Gold JP, et al. Impact of embolization during coronary artery bypass grafting on outcome and length of stay. Ann Thorac Surg. Apr 1997;63(4): Bergman P, Hadjinikolaou L, van der Linden J. Aortic atheroma is related to number of particulates captured by intra-aortic filtration in CABG. Eur J Cardiothorac Surg. Oct 2002;22(4): Clark RE, Brillman J, Davis DA, Lovell MR, Price TR, Magovern GJ. Microemboli during coronary artery bypass grafting. Genesis and effect on outcome. J Thorac Cardiovasc Surg. Feb 1995;109(2): ; discussion Hammon JW, Jr., Stump DA, Kon ND, et al. Risk factors and solutions for the development of neurobehavioral changes after coronary artery bypass grafting. Ann Thorac Surg. Jun 1997;63(6): Topol EJ, Yadav JS. Recognition of the importance of embolization in atherosclerotic vascular disease. Circulation. Feb ;101(5): Roach GW, Kanchuger M, Mangano CM, et al. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. Dec ;335(25): Banbury MK, Kouchoukos NT, Allen KB, et al. Emboli capture using the Embol-X intraaortic filter in cardiac surgery: a multicentered randomized trial of 1,289 patients. Ann Thorac Surg. Aug 2003;76(2): ; discussion Schmitz C, Weinreich S, White J, et al. Can particulate extraction from the ascending aorta reduce neurologic injury in cardiac surgery? J Thorac Cardiovasc Surg. Dec 2003;126(6): AR07316, rev date 01/2012

47 Arterial Cannulae EZ Glide Aortic Perfusion Cannula The EZ Glide aortic perfusion cannula is intended to create a gentle, dispersive flow to help protect patients from the potential dangers of embolic dislodgement. Innovative tip design disperses return flow in a gentle, conical spray pattern which reduces the likelihood of embolic disruption by reducing the exit force and line pressure Unique auto-dilating tip enables fast and easy insertion Several sizes, tip configurations, connector choices and vent plug types accommodate a variety of clinician preferences Pressure Drop (mmhg) Pressure Drop vs. Flow Rate Fr. Straight Fr. Curved Fr. Straight 24 Fr. Curved Flow Rate (L/min), H 2 O at Room Temperature 10 units per case Straight Cannula 14 inch (35 cm) overall length 3/8 inch vented connector EZS21TA 21 Fr. (7.0 mm) EZS21QTA 21 Fr. (7.0 mm)* EZS24TA 24 Fr. (8.0 mm) EZS24QTA 24 Fr. (8.0 mm)* 3/8 inch non-vented connector EZS21A 21 Fr. (7.0 mm) EZS21QA 21 Fr. (7.0 mm)* EZS24A 24 Fr. (8.0 mm) EZS24QA 24 Fr. (8.0 mm)* *These models offer a more porous vent cap design that increases the venting rate. AR07316, rev date 01/

48 Arterial Cannulae EZ Glide Aortic Perfusion Cannula (continued) Curved Cannula with Suture Bump 14.8 inch (37.6 cm) overall length 3/8 inch vented connector EZC21TA 21 Fr. (7.0 mm) EZC24TA 24 Fr. (8.0 mm) 3/8 inch non-vented connector EZC21A 21 Fr. (7.0 mm) EZC24A 24 Fr. (8.0 mm) Curved Cannula with Suture Flange 14.8 inch (37.6 cm) overall length 3/8 inch vented connector EZF21TA 21 Fr. (7.0 mm) EZF24TA 24 Fr. (8.0 mm) 3/8 inch non-vented connector EZF21A 21 Fr. (7.0 mm) EZF24A 24 Fr. (8.0 mm) 3.6 AR07316, rev date 01/2012

49 Arterial Cannulae Dispersion Tip Cannula Pressure Drop vs. Flow Rate Creates a gentle, diffuse flow for aortic perfusion Wire-reinforcement helps prevent kinking and twisting Suture flange allows for securement to the aorta 10 units per case Pressure Drop (mmhg) Fr. 24 Fr inch (30.5 cm) overall length 3/8 inch vented connector DCT21TA 21 Fr. (7.0 mm) DCT24TA 24 Fr. (8.0 mm) 3/8 inch non-vented connector DCT21A 21 Fr. (7.0 mm) DCT24A 24 Fr. (8.0 mm) 0 Flow Rate (L/min), H 2 O at Room Temperature AR07316, rev date 01/

50 Arterial Cannulae Metal Tip Cannula Pressure Drop vs. Flow Rate Non-wire reinforced tapered cannula body Thin wall, curved metal tip Suture flange allows for securement to the aorta 10 units per case Pressure Drop (mmhg) Fr. 22 Fr inch (23 cm) overall length 3/8 inch vented connector MT020TA 20 Fr. (6.7 mm) MT022TA 22 Fr. (7.3 mm) 3/8 inch non-vented connector MT020A 20 Fr. (6.7 mm) MT022A 22 Fr. (7.3 mm) 0 Flow Rate (L/min), H 2 O at Room Temperature 3.8 AR07316, rev date 01/2012

51 Arterial Cannulae Aortic Cannula, Curved, Straight & Angled Plastic Tip Suture flange allows for securement to the aorta Wire-reinforcement helps prevent kinking and twisting Curved, straight, and angled plastic tips to accommodate clinician preferences 10 units per case Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 20 Fr. 45 Angled Fr. Straight Fr. 45 Angled 22 Fr. 80 Angled Fr. Curved 22 Fr. Straight Fr. Curved 24 Fr. 45 Angled 24 Fr. Straight 24 Fr. Curved Flow Rate (L/min), H 2 O at Room Temperature 20 Fr. 80 Angled Curved Tip 11 inch (28 cm) overall length 3/8 inch vented connector ARH201190TA 20 Fr. (6.7 mm) ARH221190TA 22 Fr. (7.3 mm) ARH241190TA 24 Fr. (8.0 mm) 3/8 inch non-vented connector ARH201190A 20 Fr. (6.7 mm) ARH221190A 22 Fr. (7.3 mm) ARH241190A 24 Fr. (8.0 mm) Straight Tip 11 inch (28 cm) overall length 3/8 inch vented connector ARL2011STA 20 Fr. (6.7 mm) ARL2211STA 22 Fr. (7.3 mm) ARL2411STA 24 Fr. (8.0 mm) 3/8 inch non-vented connector ARL2011SA 20 Fr. (6.7 mm) ARL2211SA 22 Fr. (7.3 mm) ARL2411SA 24 Fr. (8.0 mm) AR07316, rev date 01/

52 Arterial Cannulae Short 45 Angled Tip 11 inch (28 cm) overall length 3/8 inch vented connector ARS020CSTA 20 Fr. (6.7 mm) ARS022CSTA 22 Fr. (7.3 mm) ARS024CSTA 24 Fr. (8.0 mm) 3/8 inch non-vented connector ARS020CSA 20 Fr. (6.7 mm) ARS022CSA 22 Fr. (7.3 mm) ARS024CSA 24 Fr. (8.0 mm) 3/8 inch acceptance ARS020CS ARS022CS ARS024CS 20 Fr. (6.7 mm) 22 Fr. (7.3 mm) 24 Fr. (8.0 mm) 80 Angled Tip With Two Side Holes 11 inch (28 cm) overall length 3/8 inch acceptance ARS020CH ARS022CH 20 Fr. (6.7 mm) 22 Fr. (7.3 mm) 3.10 AR07316, rev date 01/2012

53 Arterial Cannulae Thin Wall Aortic Cannula Pressure Drop vs. Flow Rate Thin wall design for high flow rates Extended length allows for placement to the descending aorta Obturator for ease of insertion Open tip with multiple side holes 10 units per case Pressure Drop (mmhg) Fr Flow Rate (L/min), H 2 O at Room Temperature 10 inch (25 cm) overall length 3/8 inch connector FLEXII02216A 22 Fr. (7.3 mm) AR07316, rev date 01/

54 Arterial Cannulae Axillary Perfusion Cannula Designed for direct cannulation of the axillary artery 10 units per case Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 22 Fr. 24 Fr Flow Rate (L/min), H 2 O at Room Temperature 13 inch (33 cm) overall length 3/8 inch vented connector AXA Fr. (7.3 mm) AXA Fr. (8.0 mm) 3.12 AR07316, rev date 01/2012

55 Arterial Cannulae Non-Wire-Reinforced Aortic Cannula Tip options include curved tip, straight beveled tip and 45 angled tip to accommodate clinician preferences Suture flange allows for securement to the aorta 10 units per case Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 18 Fr. Angled 18 Fr. Straight 20 Fr. Angled 20 Fr. Straight 20 Fr. Curved 22 Fr. Straight 22 Fr. Angled 22 Fr. Curved 24 Fr. Straight 24 Fr. Angled Curved Tip 9 inch (23 cm) overall length 3/8 inch vented connector AH221190TA 22 Fr. (7.3 mm) 3/8 inch non-vented connector AH201190A 20 Fr. (6.7 mm) AH221190A 22 Fr. (7.3 mm) Straight Beveled Tip 8 inch (20 cm) overall length 3/8 inch vented connector SPC Fr. (7.3 mm) Flow Rate (L/min), H 2 O at Room Temperature 3/8 inch acceptance AA018S AA020S AA022S AA024S 18 Fr. (6.0 mm) 20 Fr. (6.7 mm) 22 Fr. (7.3 mm) 24 Fr. (8.0 mm) AR07316, rev date 01/

56 Arterial Cannulae Non-Wire Reinforced Aortic Cannula (continued) 45 Angled Tip 8 inch (20 cm) overall length 3/8 inch non-vented connector SPC Fr. (7.3 mm) SPC Fr. (8.0 mm) 3/8 inch acceptance AA018C AA020C AA022C AA024C 18 Fr. (6.0 mm) 20 Fr. (6.7 mm) 22 Fr. (7.3 mm) 24 Fr. (8.0 mm) 3.14 AR07316, rev date 01/2012

57 Arterial Cannulae Aortic Cannula, Straight Beveled Tip One piece design with wire reinforcement Beveled tip with orientation markings to assist with placement Moveable suture ring to accommodate clinician preferences 10 units per case Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 20 Fr. 22 Fr. 24 Fr. Flow Rate (L/min), H 2 O at Room Temperature 12 inch (30 cm) overall length 3/8 inch vented connector AA020TFTA 20 Fr. (6.7 mm) AA022TFTA 22 Fr. (7.3 mm) AA024TFTA 24 Fr. (8.0 mm) 3/8 inch non-vented connector AA020TFA 20 Fr. (6.7 mm) AA022TFA 22 Fr. (7.3 mm) AA024TFA 24 Fr. (8.0 mm) /8 inch acceptance AA020TF AA022TF AA024TF 20 Fr. (6.7 mm) 22 Fr. (7.3 mm) 24 Fr. (8.0 mm) 8 inch (20 cm) overall length 3/8 inch non-vented connector AAS020TFA 20 Fr. (6.7 mm) AAS022TFA 22 Fr. (7.3 mm) AAS024TFA 24 Fr. (8.0 mm) AR07316, rev date 01/

58 Arterial Cannulae One-Piece Arterial Perfusion Cannula Pressure Drop vs. Flow Rate One piece design without wire reinforcement Beveled tip with orientation markings to assist with placement With or without a suture bump to accommodate clinician preferences 10 units per case Pressure Drop (mmhg) Fr. 20 Fr. 22 Fr. 24 Fr. Suture Bump 6 inch (15 cm) overall length Flow Rate (L/min), H 2 O at Room Temperature 3/8 inch acceptance APC018B APC020B APC022B APC024B 18 Fr. (6.0 mm) 20 Fr. (6.7 mm) 22 Fr. (7.3 mm) 24 Fr. (8.0 mm) No Suture Bump 6 inch (15 cm) overall length 3/8 inch acceptance APC018 APC020 APC022 APC Fr. (6.0 mm) 20 Fr. (6.7 mm) 22 Fr. (7.3 mm) 24 Fr. (8.0 mm) 3.16 AR07316, rev date 01/2012

59 Arterial Cannulae Pediatric Aortic Perfusion Cannula Designed specifically for pediatric surgery Variety of tip configurations are available to address different surgical needs 10 units per case Straight Cannula with Suture Bump 7 inch (18 cm) overall length 1/4 inch acceptance PEDA008SB PEDA010SB PEDA012SB PEDA014SB PEDA016SB 8 Fr. (2.7 mm) 10 Fr. (3.3 mm) 12 Fr. (4.0 mm) 14 Fr. (4.7 mm) 16 Fr. (5.3 mm) Curved Cannula with Suture Bump 7 inch (18 cm) overall length 1/4 inch acceptance PAA012CB PAA014CB PAA016CB 12 Fr. (4.0 mm) 14 Fr. (4.7 mm) 16 Fr. (5.3 mm) Straight Beveled Tip with Suture Ring 8 inch (20 cm) overall length 3/8 inch acceptance AA018S 18 Fr. (6.0 mm) Straight Cannula No Suture Bump 6 inch (15 cm) overall length 3/8 inch acceptance APC Fr. (6.0 mm) Pressure Drop (mmhg) Pressure Drop vs. Flow Rate PEDA008SB PEDA010SB Flow Rate (L/min), H 2 O at Room Temperature PEDA012SB PAA012CB PEDA014SB PAA014CB PEDA016SB PAA016CB APC018 AA018S AR07316, rev date 01/

60 Arterial Cannulae Arterial Cannula Accessories These accessories can be used in conjunction with Edwards arterial cannulae. 10 units per case Vent plugs and vent caps Compatible with 1/4 inch acceptance VP micron porous vent plug Compatible with 3/8 inch acceptance VP micron porous vent plug Compatible with 3/8 inch connector SPC micron porous vent cap Compatible with 3/8 inch acceptance and 3/8 inch connector ISP micron porous vent plug and vent cap + Vascular Tourniquet 2 per pouch TK2 5 inch (12.7 cm) sheath For professional use. CAutiON: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, EMBOL-X, EMBOL-X Glide, EZ Glide, and OptiSite are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR07316, rev date 01/

61 4. Venous Cannulae 4. Venous Cannulae Edwards Lifesciences offers a wide range of venous cannulae configurations and sizes, with our proprietary thin wall technology, smooth tapered tips and wire reinforcement systems to protect your patient s individual needs. Edwards venous return cannulae are designed to meet the challenges of today s cardiac surgeries by providing high flow drainage with minimal intrusion into the surgical field. AR07035, rev date 11/2011

62 Venous Cannulae Triple Stage Venous Cannula Thin-Flex triple stage venous cannula offers 34% reduction in wall thickness 20 compared to traditional technology* Thin wall technology allows for 15 exceptional flow rates with minimal intrusion into the surgical field 10 Unique dual atrial baskets designed to provide consistently high flow 5 rates, regardless of how the heart is manipulated Open lighthouse tip for higher flow rates Flow Rate (L/min) H 2 O at Room Temperature Compatible with vacuum assist venous drainage systems Optional Trim-Flex low profile venous cannula offers a unique contour design that maximizes surgical space by allowing cannulae to lay flat across the retractor and provide up to 20% lower profile in the surgical space* 10 units per case Trim-Flex Low Profile Triple Stage Venous Cannula 14.5 inch (37 cm) overall length 1/2 inch non-vented connector TRF2937O2A 29/37/37 Fr. (9.6/12.3/12.3 mm) Pressure Drop (mmhg) 25 Pressure Drop vs. Flow Rate 29/29/29 Fr. standard body 29/37/37 Fr. low profile body 29/37/37 Fr. standard body 36/46/46 Fr. low profile body 36/46/46 Fr. standard body 1/2 inch acceptance TRF2937O2 29/37/37 Fr. (9.6/12.3/12.3 mm) 16 inch (40 cm) overall length 1/2 inch non-vented connector TRF3646O2A 36/46/46 Fr. (12.0/15.3/15.3 mm) 1/2 inch acceptance TRF3646O2 36/46/46 Fr. (12.0/15.3/15.3 mm) * As compared to standard venous cannulae, data on file AR07302, rev date 01/

63 Venous Cannulae Triple Stage Venous Cannula (continued) Thin-Flex Triple Stage Venous Cannula 14.5 inch (37 cm) overall length 1/2 inch non-vented connector TF293702A 29/37/37 Fr. (9.6/12.3/12.3 mm) 1/2 inch acceptance TF /37/37 Fr. (9.6/12.3/12.3 mm) 16 inch (40 cm) overall length 3/8 inch non-vented connector TF292902A 29/29/29 Fr. (9.6/9.6/9.6 mm) 3/8 inch acceptance TF /29/29 Fr. (9.6/9.6/9.6 mm) 1/2 inch non-vented connector TF3646O2A 36/46/46 Fr. (12.0/15.3/15.3 mm) 1 /2 Bentley 1 /2 1/2 inch acceptance TF3646O2 36/46/46 Fr. (12.0/15.3/15.3 mm) 4.2 AR07302, rev date 01/2012

64 Venous Cannulae Dual Stage Venous Cannula Features patented dual stage drainage baskets designed to provide increased resistance to collapse Multiple port tip designed to increase drainage Wire-reinforcement helps prevent kinking and twisting Optional Thin-Flex dual stage venous cannula with proprietary thin wall technology designed to maximize flow rates and available space Optional Trim-Flex low profile venous cannula offers a unique contour design that maximizes surgical space by allowing cannulae to lay flat across the retractor and provide up to 20% lower profile in the surgical space* 10 units per case Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 20/20 Fr. 29/29 Fr. 29/37 Fr. flattened Flow Rate (L/min), H 2 O at Room Temperature Trim-Flex Low Profile Dual Stage Cannula 14.5 inch (37 cm) overall length 1/2 inch non-vented connector TRF2937OA 29/37 Fr. (9.6/12.3 mm) 29/37 Fr. standard 28/38 Fr. lighthouse 32/40 Fr. flattened 32/40 Fr. lighthouse 36/46 Fr. flattened 36/46 Fr. standard 34/46 Fr. lighthouse 1/2 inch acceptance TRF2937O 29/37 Fr. (9.6/12.3 mm) 16 inch (40 cm) overall length 1/2 inch non-vented connector TRF3240OA 32/40 Fr. (10.6/13.3 mm) 1/2 inch acceptance TRF3240O 32/40 Fr. (10.6/13.3 mm) 1/2 inch non-vented connector TRF3646OA 36/46 Fr. (12.0/15.3 mm) 1/2 inch acceptance TRF3646O 36/46 Fr. (12.0/15.3 mm) * As compared to standard venous cannulae, data on file AR07302, rev date 01/

65 Venous Cannulae Dual Stage Venous Cannula (continued) Thin-Flex Dual Stage Venous Cannula 14.5 inch (37 cm) overall length 1/2 inch non-vented connector TF2937OA 29/37 Fr. (9.6/12.3 mm) 1/2 inch acceptance TF2937O 29/37 Fr. (9.6/12.3 mm) 16 inch (40 cm) overall length 3/8 inch non-vented connector TF292901A 29/29 Fr. (9.6/9.6 mm) 3/8 inch acceptance TF /29 Fr. (9.6/9.6 mm) 1/2 inch non-vented connector TF3646OA 36/46 Fr. (12.0/15.3 mm) TF3343OA 33/43 Fr. (11.0/14.3 mm) 1/2 inch acceptance TF3646O TF3343O 36/46 Fr. (12.0/15.3 mm) 33/43 Fr. (11.0/14.3 mm) 4.4 AR07302, rev date 01/2012

66 Venous Cannulae Dual Stage Venous Cannula (continued) Open Lighthouse Tip 16 inch (40 cm) overall length 1/2 inch non-vented connector TR3240OA 32/40 Fr. (10.6/13.3 mm) 1/2 inch acceptance TR3240O 32/40 Fr. (10.6/13.3 mm) Extended Drainage Open Lighthouse Tip 16 inch (40 cm) overall length 1/2 inch acceptance PWR3240MH PWR3446MH 32/40 Fr. (10.6/13.3 mm) 34/46 Fr. (11.3/15.3 mm) Lighthouse Tip 16 inch (40 cm) overall length 1/2 inch non-vented connector SPC /40 Fr. (10.6/13.3 mm) 1/2 inch acceptance TR2838L TR3240L TR3446L 28/38 Fr. (9.3/12.6 mm) 32/40 Fr. (10.6/13.3 mm) 34/46 Fr. (11.3/15.3 mm) AR07302, rev date 01/

67 Venous Cannulae Single Stage Venous Cannula One piece wire reinforced cannula Proprietary thin wall design to maximize venous drainage Multiple port tip designed to increase drainage Thin-Flex venous cannula with proprietary thin wall technology designed to maximize flow rates and available space 10 units per case Thin-Flex Straight Open Lighthouse Tip 14 inch (35 cm) overall length 1/4 inch or 3/8 inch acceptance TF018L 18 Fr. (6.0 mm) TF020L 20 Fr. (6.7 mm) TF022L 22 Fr. (7.3 mm) TF024L 24 Fr. (8.0 mm) 3/8 inch acceptance TF026L 26 Fr. (8.7 mm) TF028L 28 Fr. (9.3 mm) Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 18 Fr. 20 Fr. 22 Fr. 24 Fr Flow Rate (L/min), H 2 O at Room Temperature 26 Fr. 28 Fr. 30 Fr. 32 Fr. 34 Fr. 36 Fr. 38 Fr. 40 Fr. 16 inch (40 cm) overall length 3/8 inch acceptance TF030L 30 Fr. (10.0 mm) TF032L 32 Fr. (10.7 mm) TF034L 34 Fr. (11.3 mm) TF036L 36 Fr. (12.0 mm) TF038L 38 Fr. (12.6 mm) Thin-Flex Straight Open Lighthouse Tip with Multiple Side Holes 16 inch (40 cm) overall length 3/8 inch acceptance TF032MH TF036MH 32 Fr. (10.7 mm) 36 Fr. (12.0 mm) 4.6 AR07302, rev date 01/2012

68 Venous Cannulae Single Stage Venous Cannula (continued) Thin-Flex Right Angled Open Lighthouse Tip 14 inch (35 cm) overall length 1/4 inch or 3/8 inch acceptance TF018L90 18 Fr. (6.0 mm) TF020L90 20 Fr. (6.7 mm) TF022L90 22 Fr. (7.3 mm) TF024L90 24 Fr. (8.0 mm) 3/8 inch acceptance TF026L90 TF028L90 26 Fr. (8.7 mm) 28 Fr. (9.3 mm) 16 inch (40 cm) overall length 3/8 inch acceptance TF030L90 TF032L90 TF034L90 TF036L90 TF038L90 TF040L90 30 Fr. (10.0 mm) 32 Fr. (10.7 mm) 34 Fr. (11.3 mm) 36 Fr. (12.0 mm) 38 Fr. (12.6 mm) 40 Fr. (13.3 mm) AR07302, rev date 01/

69 Venous Cannulae Single Stage Venous Cannula One piece wire reinforced cannula Proprietary thin wall design to maximize venous drainage Multiple port tip designed to increase drainage Thin-Flex venous cannula with proprietary thin wall technology designed to maximize flow rates and available space 10 units per case Thin-Flex 90º Plastic Tip with Side Holes 14 inch (35 cm) overall length 3/8 inch acceptance TF018O90 18 Fr. (6.0 mm) TF020O90 20 Fr. (6.7 mm) Pressure Drop (mmhg) Pressure Drop vs. Flow Rate Flow Rate (L/min), H 2 O at Room Temperature 18 Fr Fr. 22 Fr. 24 Fr. 28 Fr. 15 inch (38 cm) overall length 3/8 inch acceptance TF022O90 22 Fr. (7.3 mm) TF024O90 24 Fr. (8.0 mm) TF028O90 28 Fr. (9.3 mm) 4.8 AR07302, rev date 01/2012

70 Venous Cannulae Malleable Single Stage Venous Cannula 100 Pressure Drop vs. Flow Rate 24 Fr. 26 Fr. Features a one-piece, wire reinforced body with internal malleable wire which allows the cannula to be shaped based on the clinician s needs Open lighthouse tip that is designed to maximize venous drainage 10 units per case Pressure Drop (mmhg) Fr. 30 Fr. 32 Fr. 34 Fr. 36 Fr Flow Rate (L/min), H 2 O at Room Temperature 14 inch (35 cm) overall length 1/4 inch or 3/8 inch acceptance TFM018L 18 Fr. (6.0 mm) TFM020L 20 Fr. (6.7 mm) TFM022L 22 Fr. (7.3 mm) TFM024L 24 Fr. (8.0 mm) 3/8 inch acceptance TFM026L TFM028L 26 Fr. (8.7 mm) 28 Fr. (9.3 mm) 16 inch (40 cm) overall length 3/8 inch acceptance TFM030L TFM032L TFM034L TFM036L 30 Fr. (10.0 mm) 32 Fr. (10.7 mm) 34 Fr. (11.3 mm) 36 Fr. (12.0 mm) AR07302, rev date 01/

71 Venous Cannulae Vacuum Assist Venous Cannula Designed specifically for use with vacuum assist venous drainage Features a Thin-Flex proprietary thin wall technology which allows for exceptional flow rates with minimal intrusion into the surgical field 10 units per case Straight Cannula, Standard Tip 14 inch (35 cm) overall length 3/8 acceptance VC Fr. (7.3 mm) Straight Cannula, Short Tip 14 inch (35 cm) overall length 3/8 acceptance VCS Fr.(7.3 mm) VCS Fr. (8.0 mm) Right Angled Cannula, Standard Tip 14 inch (35 cm) overall length 3/8 acceptance VC Fr. (7.3 mm) Right Angled Cannula, Short Tip 14 inch (35 cm) overall length 3/8 acceptance VCS02290 VCS02490 VCS02690 VCS Fr. (7.3 mm) 24 Fr. (8.0 mm) 26 Fr. (8.7 mm) 28 Fr. (9.3 mm) 4.10 AR07302, rev date 01/2012

72 Venous Cannulae Vacuum Assist Cannula Designed specifically for use with vacuum assist venous drainage Multiple side holes to minimize occlusion Internal dilator to assist with ease of placement 10 units per case Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 24 Fr. 22 Fr Flow Rate (L/min), H 2 O at Room Temperature 15 inch (37.5 cm) overall length 3/8 inch non-vented connector FLEXII022V 22 Fr. (7.3 mm) 14 inch (35 cm) overall length 3/8 inch vented connector TFV Fr. (8.0 mm) AR07302, rev date 01/

73 Venous Cannulae Pediatric Dual Stage Venous Cannula Pressure Drop vs. Flow Rate TF2020O Thin-Flex venous cannula with proprietary thin wall technology designed to maximize flow rates and available space Patented dual stage drainage baskets designed to provide increased resistance to collapse Thin wall and kink resistant wire-reinforced body Indicated for pediatric use Pressure Drop (mmhg) Flow Rate (L/min), H 2 O at Room Temperature 10 units per case Thin-Flex Dual Stage Venous Cannula 14 inch (35 cm) overall length 1/4 inch or 3/8 inch acceptance TF2020O 20/20 Fr. (6.7/6.7 mm) 4.12 AR07302, rev date 01/2012

74 Venous Cannulae Pediatric Single Stage Venous Cannula Fr. Pressure Drop vs. Flow Rate 14 Fr. 16 Fr. 18 Fr. Thin-Flex dual stage venous cannula with proprietary thin wall technology designed to maximize flow rates and available space Indicated for pediatric use 10 units per case Pressure Drop (mmhg) Flow Rate (L/min), H 2 O at Room Temperature Thin-Flex Straight Open Lighthouse Tip 11 inch (28 cm) overall length 1/4 inch acceptance TF012L TF014L TF016L 12 Fr. (4.0 mm) 14 Fr. (4.7 mm) 16 Fr. (5.3 mm) 14 inch (35 cm) overall length 1/4 or 3/8 inch acceptance TF018L 18 Fr. (6.0 mm) Thin-Flex Right Angled Open Lighthouse Tip 11 inch (28 cm) overall length 1/4 inch acceptance TF012L90 TF014L90 TF016L90 12 Fr. (4.0 mm) 14 Fr. (4.7 mm) 16 Fr. (5.3 mm) 14 inch (35 cm) overall length 1/4 or 3/8 inch acceptance TF018L90 18 Fr. (6.0 mm) AR07302, rev date 01/

75 Venous Cannulae Pediatric Single Stage Venous Cannula Pressure Drop vs. Flow Rate 8 Fr. 10 Fr. 12 Fr. 14 Fr. Thin-Flex dual stage venous cannula with proprietary thin wall technology designed to maximize flow rates and available space Indicated for pediatric use 10 units per case Pressure Drop (mmhg) Fr. 18 Fr. Thin-Flex 90 Plastic Tip with Side Holes 11 inch (28 cm) overall length Flow Rate (L/min), H 2 O at Room Temperature 1/4 inch acceptance TF008O90 TF010O90 8 Fr. (2.7 mm) 10 Fr. (3.3 mm) 13 inch (33 cm) overall length 1/4 inch or 3/8 inch acceptance TF012O90 12 Fr. (4.0 mm) TF014O90 14 Fr. (4.7 mm) TF016O90 16 Fr. (5.3 mm) 14 inch (35 cm) overall length 3/8 inch acceptance TF018O90 18 Fr. (6.0 mm) For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, Thin-Flex, and Trim-Flex are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR07302, rev date 01/

76 5. Femoral Cannulae Edwards Lifesciences offers easy-to-use and ultra thin wall femoral cannulae designed to accommodate multiple surgical techniques and a variety of clinician preferences. Edwards femoral cannulae are specifically designed to help you protect your patients during on-pump cardiac surgery by minimizing trauma and expanding your surgical options. 5. Femoral Cannulae AR07035, rev date 11/2011

77 Femoral Cannulae Fem-Flex II Femoral Arterial Cannula 200 Pressure Drop vs. Flow Rate 16 Fr. Fem-Flex II femoral arterial cannula is designed with ultra-thin wall technology for enhanced flow and flexibility. Tapered tip and smooth dilator to cannula transition facilitates insertion Polyurethane body with wire reinforcement helps prevent kinking Radiopaque tip for visualization during placement Accommodates up to guidewire Pressure Drop (mmhg) Fr Fr Flow Rate (L/min), H 2 O at Room Temperature 1 unit per case 9.5 inch (24 cm) overall length 6.0 inch (15 cm) effective length 3/8 inch vented connector FEMII016A 16 Fr. (5.3 mm) FEMII018A 18 Fr. (6.0 mm) FEMII020A 20 Fr. (6.7 mm) 3/8 inch non-vented connector FEMII016AS 16 Fr. (5.3 mm) FEMII018AS 18 Fr. (6.0 mm) FEMII020AS 20 Fr. (6.7 mm) AR07313, rev date 01/

78 Femoral Cannulae Fem-Flex Arterial Cannula with Internal Dilator One-piece wire-reinforced cannula body Internal dilator 5 units per case Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 20 Fr. 22 Fr. 24 Fr. w/ side holes 24 Fr Flow Rate (L/min), H 2 O at Room Temperature Open Tip 10.5 inch (26.7 cm) overall length 8.5 inch (21.6 cm) effective length 3/8 inch vented connector TFA Fr. (6.7 mm) TFA Fr. (7.3 mm) TFA Fr. (8.0 mm) Open Tip with Side Holes 10.5 inch (26.7 cm) overall length 8.5 inch (21.6 cm) effective length 3/8 inch vented connector TFA02425H 24 Fr. (8.0 mm) 5.2 AR07313, rev date 01/2012

79 Femoral Cannulae FemTrak Femoral Venous Cannula Wire-reinforced ultra-thin wall body that helps minimize kinking and maximize flow rates Metal ferrule tipped cannula to provide an atraumatic and smooth transition between cannula and introducer Soft, flexible tip on the introducer designed to navigate through tortuous anatomy Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 20 Fr. 24 Fr. 1 unit per case Flow Rate (L/min), H 2 O at Room Temperature 29 inch (74 cm) overall length 21.6 inch (55 cm) effective length 3/8 inch non-vented connector FTV Fr. (6.7 mm) 34 inch (86 cm) overall length 26.8 inch (68 cm) effective length 3/8 inch non-vented connector FTV Fr. (8.0 mm) AR07313, rev date 01/

80 Femoral Cannulae VFEM Femoral Venous Cannula Ultra-thin wall technology enhances venous drainage and provides flexibility for a variety of surgical applications Wire-reinforced body to help prevent kinking A tapered tip and smooth dilator-to-cannula for ease of insertion Extended section of drainage holes designed to maximize venous drainage Pressure Drop (mmhg) Pressure Drop vs. Flow Rate 18 Fr. 20 Fr. 22 Fr. 24 Fr. 28 Fr. 1 unit per case 29 inch (74 cm) overall length 21.6 inch (55 cm) effective length 3/8 inch non-vented connector VFEM Fr. (6.0 mm) VFEM Fr. (6.7 mm) VFEM Fr. (7.3 mm) Flow Rate (L/min), H 2 O at Room Temperature 34 inch (86 cm) overall length 26.8 inch (68 cm) effective length 3/8 inch non-vented connector VFEM Fr. (8.0 mm) VFEM Fr. (9.3 mm) 5.4 AR07313, rev date 01/2012

81 Femoral Cannulae Fem-Flex II Pediatric Femoral Arterial Cannula 200 Pressure Drop vs. Flow Rate 8 Fr. 10 Fr. 12 Fr. 14 Fr. Fem-Flex II pediatric femoral arterial cannula is designed with ultra-thin wall technology for enhanced flow and flexibility. Tapered tip and smooth dilator to cannula transition facilitates insertion Polyurethane body with wire reinforcement helps prevent kinking Radiopaque tip for visualization during placement Pressure Drop (mmhg) Flow Rate (L/min), H 2 O at Room Temperature 5 units per case Pediatric 7.75 inch (19.7 cm) overall length 2.6 inch (6.5 cm) effective length 1/4 inch vented connector FEMII008AT 8 Fr. (2.7 mm) FEMII010AT 10 Fr. (3.3 mm) FEMII012AT 12 Fr. (4.0 mm) FEMII014AT 14 Fr. (4.7 mm) 1/4 inch non-vented connector FEMII008A 8 Fr. (2.7 mm) FEMII010A 10 Fr. (3.3 mm) FEMII012A 12 Fr. (4.0 mm) FEMII014A 14 Fr. (4.7 mm) AR07313, rev date 01/

82 Femoral Cannulae Fem-Flex II Pediatric Femoral Venous Cannula Fr. Pressure Drop vs. Flow Rate 10 Fr. 12 Fr. 14 Fr. Fem-Flex II pediatric femoral venous cannula is designed with ultra-thin wall technology for enhanced flow and flexibility. Tapered tip and smooth dilator to cannula transition facilitates insertion Polyurethane body with wire reinforcement helps prevent kinking Radiopaque tip for visualization during placement Extended section of drainage holes designed to maximize venous drainage Pressure Drop (mmhg) Flow Rate (L/min), H 2 O at Room Temperature 5 units per case Pediatric 9.5 inch (24 cm) overall length 4.5 inch (11.5 cm) effective length 1/4 inch non-vented connector FEMII008V 8 Fr. (2.7 mm) FEMII010V 10 Fr. (3.3 mm) FEMII012V 12 Fr. (4.0 mm) FEMII014V 14 Fr. (4.7 mm) 5.6 AR07313, rev date 01/2012

83 ML Femoral Cannulae Percutaneous Insertion Kit The percutaneous insertion kit is designed to facilitate percutaneous insertion of a femoral cannula. The kit includes the following components: Number 11 scalpel 18 ga. insertion needle 5 ml syringe Three dilators: 8 Fr./12 Fr./16 Fr inch guidewire BARD-PARKER 5 units per case Arterial Insertion Kit PIKA 100 cm guidewire Venous Insertion Kit PIKV 210 cm guidewire AR07313, rev date 01/

84 BARD-PARKER Femoral Cannulae Femoral Cannulae Accessories 10 units per case Dilator with Number 11 Scalpel 8.9 inch (22.5 cm) overall length DIL Fr. (4.0 mm) Guidewire Kit ART inch (0.97 mm) guidewire cm (39.4 inch) overall lenght, 1 ml syringe and 18 ga. insertion needle VEN inch (0.97 mm) guidewire cm (82.7 inch) overall lenght, 1 ml syringe and 18 ga. insertion needle 1.0ML For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, Fem-Flex, Fem-Flex II, and FemTrak are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR07313, rev date 01/

85 6. Cardioplegia Cannulae Edwards Lifesciences provides a wide range of antegrade and retrograde cardioplegia products designed to maximize global myocardial protection and allow you to provide a greater level of care for your patients. Edwards cardioplegia cannulae are specifically designed to help you protect your patients during on-pump cardiac surgery by maximizing myocardial protection. 6. Cardioplegia Cannulae AR07035, rev date 11/2011

86 OFF OFF Cardioplegia Cannulae Self-Inflating Retrograde Cardioplegia Catheter with Retractaguard Technology The self-inflating retrograde cardioplegia catheter is designed to maximize patient protection by providing global myocardial protection. Balloon self-inflates when cardioplegia is being delivered Variety of handle and stylet designs that facilitate insertion for a variety of surgical techniques Utilizes proprietary Retractaguard technology, which helps the cannula retain its shape after deployment and prevent balloon slippage 10 units per case Pressure Drop (mmhg) Pressure Drop vs. Flow Rate Flow Rate (ml/min), H 2 O at Room Temperature Pre-Shaped Stylet and Handle 10.6 inch (27 cm) overall length 12 Fr. 14 Fr. 18 mm textured balloon RC2014S 14 Fr. (4.7 mm) 20 mm textured balloon RC2014LBS 14 Fr. (4.7 mm) 12.5 inch (32 cm) overall length 18 mm textured balloon RC Fr. (4.0 mm) RC Fr. (4.7 mm) 20 mm textured balloon RC2014LB 14 Fr. (4.7 mm) AR07311, rev date 01/

87 OFF OFF Cardioplegia Cannulae Self-Inflating Retrograde Cardioplegia Catheter with Retractaguard Technology (continued) Guidewire Stylet 12.5 inch (32 cm) overall length 18 mm textured balloon RC2012M 12 Fr. (4.0 mm) RC2014M 14 Fr. (4.7 mm) 20 mm textured balloon RC2014LBM 14 Fr. (4.7 mm) ISP Fr. (4.7 mm)* *Female luer instead of stopcock Hourglass Handle and Guidewire Stylet 12.5 inch (32 cm) overall length 18 mm textured balloon ISP Fr. (4.7 mm) 6.2 AR07311, rev date 01/2012

88 OFF OFF OFF Cardioplegia Cannulae Self-Inflating Retrograde Cardioplegia Catheter 60 Pressure Drop vs. Flow Rate 9 Fr. The self-inflating retrograde cardioplegia catheter is designed to maximize patient protection by providing global myocardial protection. Balloon self-inflates when cardioplegia is being delivered Variety of handle and stylet designs that facilitate insertion for a variety of surgical techniques Pressure Drop (mmhg) Flow Rate (ml/min), H 2 O at Room Temperature Pre-Shaped Stylet and Handle 14 Fr. 5 units per case 8 inch (20 cm) overall length 9 mm smooth balloon RC09 9 Fr. (3.0 mm) 10 units per case 10.6 inch (27 cm) overall length 18 mm smooth balloon RC Fr. (4.7 mm) 20 mm smooth balloon NPC Fr. (4.7 mm) 14 mm textured balloon RC014IT 14 Fr. (4.7 mm) 18 mm textured balloon RC014T 14 Fr. (4.7 mm) 20 mm textured balloon NPC014T 14 Fr. (4.7 mm) AR07311, rev date 01/

89 OFF OFF OFF Cardioplegia Cannulae Self-Inflating Retrograde Cardioplegia Catheter (continued) Guidewire Stylet 5 units per case 8 inch (20 cm) overall length 9 mm smooth balloon RC09M 9 Fr. (3.0 mm) 10 units per case 10.6 inch (27 cm) overall length 18 mm smooth balloon RC014M 14 Fr. (4.7 mm) 18 mm textured balloon RC014MT 14 Fr. (4.7 mm) 6.4 AR07311, rev date 01/2012

90 OFF OFF Cardioplegia Cannulae Manually Inflating Retrograde Cardioplegia Catheter 60 Pressure Drop vs. Flow Rate The manually inflating retrograde cardioplegia catheter is designed to maximize patient protection by providing global myocardial protection. Manual inflation of the balloon allows surgical control over balloon inflation Variety of handle and stylet designs that facilitate insertion for a variety of surgical techniques Optional Retractaguard technology to prevent balloon slippage Pressure Drop (mmhg) Flow Rate (ml/min), H 2 O at Room Temperature 12 Fr., polyurethane 14 Fr., polyurethane 14 Fr., silicone 10 units per case Pre-shaped Stylet and Handle Pre-shaped Stylet and Handle 12.5 inch (32 cm) overall length Textured polyurethane balloon and Retractaguard lumen RC2012MIBB 12 Fr. (4.0 mm) RC2014MIBB 14 Fr. (4.7 mm) Smooth silicone balloon RC014MIBB 14 Fr. (4.7 mm) Textured silicone balloon SRT014MIBB 14 Fr. (4.7 mm) AR07311, rev date 01/

91 OFF OFF Cardioplegia Cannulae Manually Inflating Retrograde Cardioplegia Catheter (continued) Guidewire Stylet 12.5 inch (32 cm) overall length Textured polyurethane balloon and Retractaguard lumen RC2012MIB 12 Fr. (4.0 mm) RC2014MIB 14 Fr. (4.7 mm) Smooth silicone balloon PLD014MIBH 14 Fr. (4.7 mm)* *Female luer instead of stopcock RC014MIB 14 Fr. (4.7 mm) Textured silicone balloon SRT014MIB 14 Fr. (4.7 mm) Hourglass Handle and Guidewire Stylet 12.5 inch (32 cm) overall length Smooth silicone balloon ISP Fr. (4.7 mm) 6.6 AR07311, rev date 01/2012

92 Cardioplegia Cannulae Antegrade Cardioplegia Cannula The antegrade cardioplegia cannula is designed to administer antegrade cardioplegia through the aortic root. It is available in standard, vented and pressure monitoring configurations designed to meet a variety of surgical needs. The antegrade cardioplegia cannula incorporates a number of unique safety features designed for added patient protection, including: Smaller gauge insertion needle and center-vented needle Atraumatic, soft tip cannula Models available with left heart venting and/or pressure monitoring lines Pressure Drop (mmhg) Pressure Drop vs. Flow Rate Flow Rate (ml/min), H2O at Room Temperature 9 Fr. (11 ga.), w/ pressure monitoring line and vent 7 Fr. (14 ga.) 9 Fr. (11 ga.), w/ pressure monitoring line 9 Fr. (12 ga.) 10 units per case Standard Cannula AR012 AR014 9 Fr. (3.0 mm) 7 Fr. (2.3 mm) Standard Cannula with Moveable Suture Ring AR012S AR014S 9 Fr. (3.0 mm) 7 Fr. (2.3 mm) Standard Cannula with Pressure Monitoring Line ARC011M 9 Fr. (3.0 mm) OFF AR07311, rev date 01/

93 Cardioplegia Cannulae Antegrade Cardioplegia Cannula (continued) Vented Cannula AR012V AR014V 9 Fr. (3.0 mm) 7 Fr. (2.3 mm) Vented Cannula with Extra Clamp AR014VC SPC Fr. (2.3 mm) 9 Fr. (3.0 mm) AR014VC SPC2189 Vented Cannula with Pressure Monitoring Line ATC011MV 9 Fr. (3.0 mm) RMI OFF 6.8 AR07311, rev date 01/2012

94 Cardioplegia Cannulae Cardioplegia Sets These tubing sets are used to distribute cardioplegia from the heart lung machine to the cardioplegia catheters. Available in many configurations to meet a variety of procedural needs and techniques 10 units per case Single Tubing Set Tubing length: 12 (30 cm) CDS001 Straight adapter Two Tubing Set Tubing length: 12 (30 cm) CDS002Y Recirculating Y-adapter CDS003P Un-even Y-adapter CDS006 Aortic root perfusion with vent CDS006S Aortic root perfusion with vent and softer tubing AR07311, rev date 01/

95 Cardioplegia Cannulae Cardioplegia Sets (continued) Three Tubing Set Tubing length: 12 (30 cm) CDS008 Three vessel lines CDS014 Retrograde and aortic root perfusion with vent Four Tubing Set Tubing length: 12 (30 cm) CDS004 CDS004S CDS004WV Three vessel lines and aortic root perfusion line Three vessel lines and aortic root perfusion line with softer tubing Three vessel lines with attached vessel cannulae and aortic root perfusion line 6.10 AR07311, rev date 01/2012

96 OFF OFF OFF OFF OFF OFF OFF Cardioplegia Cannulae Monitoring and Infusion Sets These tubing sets allow distribution of cardioplegia and pressure monitoring. Surgeon operated sets with controls within the sterile field Perfusionist operated set with longer tubing that allows control outside of the sterile field 10 units per case Surgeon Operated Set MIS005 Antegrade and retrograde infusion MIS003 Antegrade and retrograde infusion MIS001 Antegrade and retrograde infusion MIS001CP Antegrade and retrograde infusion with one vessel line MIS001CP2 Antegrade and retrograde infusion with three vessel lines MIS001CP3 ` Antegrade and retrograde infusion with four vessel lines Perfusionist Operated Set MIS004 Antegrade and retrograde infusion AR07311, rev date 01/

97 Cardioplegia Cannulae For professional use. CAUTion: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, and Retractaguard are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR07311, rev date 01/

98 7. Blood Management Edwards Lifesciences provides a wide range of blood management products designed to improve visualization in the surgical field and allow you to provide a greater level of care for your patients. Edwards blood management products are designed to accommodate a variety of surgeon preferences and techniques to help your team maintain a well vented surgical site. 7. Blood Management AR07035, rev date 11/2011

99 Blood management Vent Catheter The vent catheter is designed for intra-cardiac venting and features: PVC or silicone body Malleable stylet and catheter body configurations Variety of drainage hole configurations Pediatric and adult sizes 10 units per case Malleable Stylet and Malleable PVC Catheter Body 1/4 inch connector 14 inch (35 cm) overall length EM Fr. (4.0 mm) Malleable Stylet and PVC Catheter Body 1/4 inch connector 14 inch (35 cm) overall length E Fr. (5.7 mm) E Fr. (5.7 mm) Malleable Stylet and PVC Catheter Body 1/4 inch connector 10.6 inch (27 cm) overall length PE Fr. (4.0 mm) Guidewire Stylet and Silicone Catheter Body 1/4 inch connector 15.5 inch (39.4 cm) overall length E Fr. (6.7 mm) cm of drainage holes cm of drainage holes cm of drainage holes 4 6 cm of drainage holes AR07310, rev date 01/

100 Blood management Malleable Suction Wand with Handle The malleable suction wand features: Variable flow vacuum port handle Malleable stainless steel shaft that can be shaped for a variety of surgeon preferences 10 units per case 1/4 inch connector S050 S052 6 Fr. (2.0 mm) Frazier tip 6 Fr. (2.0 mm) Silicone tip Flexible Suction Wand These flexible suction wands feature: Flexible catheter body Fluted tip configuration 10 units per case Wire-reinforced Tubing Body 1/4 inch connector 15 inch (38 cm) overall length S Fr. (7.3 mm) Fluted tip Flexible Tubing Body 1/4 inch connector 15 inch (38 cm) overall length S Fr. (7.3 mm) Fluted tip 7.2 AR07310, rev date 01/2012

101 Blood management Rigid Suction Wand The rigid suction wands offer: Variety of catheter bodies and tip configurations Pre-angled stainless steel body 10 units per case Rigid Wands with Angled Tip 1/4 inch connector 11.5 inch (29 cm) overall length S022 S Fr. (9.3 mm) Mushroom tip 12 Fr. (4.0 mm) Flexible tapered tip 12 inch (30.5 cm) overall length S077 9 Fr. (3.0 mm) Mini-point tip with two side holes 12.4 inch (31.5 cm) overall length S Fr. (3.7 mm) Fluted tip 13 inch (33 cm) overall length S Fr. (7.3 mm) Fluted tip AR07310, rev date 01/

102 Blood management Pericardial Sump This sump features a weighted stainless steel spring tip and flexible tubing designed to facilitate pericardial drainage. 10 units per case 1/4 inch connector 14.9 inch (37.8 cm) overall length S Fr. (7.0 mm) VisuFlo II Surgical Site Visualization Wand The VisuFlo II wand allows improved visualization of distal anastomoses during coronary artery bypass graft surgeries. It provides a fine mist of saline and CO 2 through a malleable atraumatic tip designed to improve visualization. Finger tip control allows for precise adjustments Ergonomic handle designed for ease of use 108 inch (274 cm) gas and saline tubing Incorporated CO 2 filter 5 units per case 1/4 inch connector VF2 7 Fr. (2.33 mm) tip 7.4 AR07310, rev date 01/2012

103 Blood management Anastaflo Intravascular Shunt The Anastaflo intravascular shunt features: Thru-lumen that provides perfusion and enhances blood flow Silicone bulb that is designed to help maintain a bloodless field Flexible silicone shaft designed for easy insertion and removal Radiopaque bulb and tab that facilitate fluoroscopic visualization 5 units per case 0.5 inch (1.2 cm) overall length IVS12512 IVS1512 IVS17512 IVS2012 IVS2512 IVS Fr. (1.25 mm) bulb 4.5 Fr. (1.5 mm) bulb 5.25 Fr. (1.75 mm) bulb 6 Fr. (2.0 mm) bulb 7.5 Fr. (2.5 mm) bulb 9 Fr. (3.0 mm) bulb 1.2 inch (3.0 cm) overall length IVS1530 IVS2030 IVS Fr. (1.5 mm) bulb 6 Fr. (2.0 mm) bulb 7.5 Fr. (2.5 mm) bulb AR07310, rev date 01/

104 Blood management Blood Flow Monitoring The FLOtector surgical blood flow detector is designed for verification of graft patency. Microvascular Doppler system allows identification of blood flow through coronary arteries and bypass grafts Can also be used to locate internal mammary artery FLOtector Intraoperative Surgical Blood Flow Detector 1 unit per case FLO001 Transceiver FLOtector Detector Probes 4 units per case FLO002S FLO003S 8 Fr. (2.7 mm) Curved tip 8 Fr. (2.7 mm) Straight tip Pressure Monitoring The pressure monitoring catheter is designed to measure pressure in the left atrium and features a luer connection and stopcock. 10 units per case Left Atrial Pressure Monitoring 20 inch (50.6 cm) overall length LAP17 LAP20 17 ga. catheter 14 ga. introducer 20 ga. catheter 16 ga. introducer For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, Anastaflo, FLOtector, and VisuFlo are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR07310, rev date 01/

105 Index Index ThruPort Systems Edwards Protection Cannulae Products by Model Index AR07035, rev date 11/2011

106 8. ThruPort Systems 8. ThruPort Systems AR07035, rev date 11/2011

107 Thruport systems ThruPort Systems Disposables Retrograde Cardioplegia PR Vent Catheter EV Aortic Occlusion EC ICF Arterial Cannulae AC ER21B ER23B ED24A IS19A OPTI OPTI OPTI OPTI SS23A SS23AM SS23S SS23SM Venous Cannulae QD QD Accessory Devices KP PVL PVM PVS VPP Resuables Retraction ERGAR ERGAR ERGAR ERGAR ERGAR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR Long Shafted Instruments ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGS ERGS ERGS (continued on next page) AR08005, rev date 06/

108 Thruport systems ThruPort Systems (continued) Resuables (continued) Long Shafted Instruments ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS Accessories ERGB ERGB ERGB ERGC ERGC ERGH ERGH ERGH ERGH ERGH ERGH ERGH ERGH ERGH ERGM ERGM ERGR ERGR ERGR ERGR ERGR AR08005, rev date 06/2012

109 9. Edwards Protection Cannulae 9. Edwards Protection Cannulae AR07035, rev date 11/2011

110 Edwards protection cannulae Edwards Protection Cannulae Arterial Cannulae AA018C AA018S AA020C AA020S AA020TF AA020TFA AA020TFTA AA022C AA022S AA022TF AA022TFA AA022TFTA AA024TF AA024TFA AA024C AA024S AA024TFTA AAS020TFA AAS022TFA AAS024TFA AH201190A AH221190A AH221190TA APC & 3.17 APC018B APC APC020B APC APC022B APC APC024B ARH201190A ARH201190TA ARH221190A ARH221190TA ARH241190A ARH241190TA ARL2011SA ARL2011STA ARL2211SA ARL2211STA ARL2411SA ARL2411STA ARS020CH ARS020CS ARS020CSA ARS020CSTA ARS022CH ARS022CS ARS022CSA ARS022CSTA ARS024CS ARS024CSA ARS024CSTA AXA AXA CA DCT21A DCT21TA DCT24A DCT24TA EXGF24D EXGF24LLD EXGF24LL2D EXGF24MMD EXGF24MM2D EXGF24SS2D EXGF24SS2D EXGF24XLD EXGF24XL2D EXGF24XSD EXGF24XS2D EXLLD EXMMD EXSSD EXXLD EXXSD EZC21A EZC21TA EZC24A EZC24TA EZF21A EZF21TA EZF24A EZF24TA EZS21A EZS21QA EZS21QTA EZS21TA EZS24A EZS24QA EZS24QTA EZS24TA FLEXII02216A HI HI ISP MT020A MT020TA MT022A MT022TA OPTI OPTI OPTI OPTI PAA012CB PAA014CB PAA016CB PEDA008SB PEDA010SB PEDA012SB PEDA014SB PEDA016SB SPC SPC SPC SPC TK VP VP AR08005, rev date 06/

111 Edwards protection cannulae Edwards Protection Cannulae (continued) Venous Cannulae FLEXII022V PWR3240MH PWR3446MH SPC TF008O TF010O TF012L TF012L TF012O TF014L TF014L TF014O TF016L TF016L TF016O TF018L TF018L (Pediatric) TF018L TF018L90 (Pediatric) TF018O TF018O90 (Pediatric) TF020L TF020L TF020O TF022L TF022L TF022O TF024L TF024L TF024O TF026L TF026L TF028L TF028L TF028O TF030L TF030L TF032L TF032L TF032MH TF034L TF034L TF036L TF036L TF036MH TF038L TF038L TF040L TF2020O TF TF292901A TF2937O TF2937OA TF TF292902A TF TF293702A TF3343O TF3343OA TF3646O TF3646OA TF3646O TF3646O2A TFM018L TFM020L TFM022L TFM024L TFM026L TFM028L TFM030L TFM032L TFM034L TFM036L TFVO TR2838L TR3240L TR3446L TR3240O TR3240OA TRF2937O TRF2937OA TRF2937O TRF2937O2A TRF3240O TRF3240OA TRF3646O TRF3646OA TRF3646O TRF3646O2A VC VC VCS VCS VCS VCS VCS VCS AR08005, rev date 06/2012

112 Edwards protection cannulae Edwards Protection Cannulae (continued) Femoral Cannulae ART DIL FEMII008A FEMII008AT FEMII008V FEMII010A FEMII010AT FEMII010V FEMII012A FEMII012AT FEMII012V FEMII014A FEMII014AT FEMII014V FEMII016A FEMII016AS FEMII018A FEMII018AS FEMII020A FEMII020AS FTV FTV PIKA PIKV TFA TFA TFA TFA02425H VEN VFEM VFEM VFEM VFEM VFEM Cardioplegia Cannulae AR AR012S AR012V AR AR014S AR014V AR014VC ARCO11M ATC011MV CDS CDS002Y CDS003P CDS CDS004S CDS004WV CDS CDS006S CDS CDS ISP ISP ISP MIS MIS001CP MIS001CP MIS001CP MIS MIS MIS NPC NPC014T PLD014MIBH RC RC09M RC RC014IT RC014M RC014MIB RC014MIBB RC014MT RC014T RC RC2012M RC2012MIB RC2012MIBB RC RC2014LB RC2014LBM RC2014LBS RC2014M RC2014MIB RC2014MIBB RC2014S SPC SRT014MIB SRT014MIBB AR08005, rev date 06/

113 Edwards protection cannulae Edwards Protection Cannulae (continued) Blood Management E E E EM FLO FLO002S FLO003S IVS IVS IVS IVS IVS IVS IVS IVS IVS LAP LAP PE S S S S S S S S S S VF AR08005, rev date 06/2012

114 10. Products by Model AR07035, rev date 11/ Products by Model

115 Products by model Products by Model AA018C AA018S AA020C AA020S AA020TF AA020TFA AA020TFTA AA022C AA022S AA022TF AA022TFA AA022TFTA AA024TF AA024TFA AA024C AA024S AA024TFTA AAS020TFA AAS022TFA AAS024TFA AC AH201190A AH221190A AH221190TA APC & 3.17 APC018B APC APC020B APC APC022B APC APC024B AR AR012S AR012V AR AR014S AR014V AR014VC ARCO11M ARH201190A ARH201190TA ARH221190A ARH221190TA ARH241190A ARH241190TA ARL2011SA ARL2011STA ARL2211SA ARL2211STA ARL2411SA ARL2411STA ARS020CH ARS020CS ARS020CSA ARS020CSTA ARS022CH ARS022CS ARS022CSA ARS022CSTA ARS024CS ARS024CSA ARS024CSTA ART ATC011MV AXA AXA CA CDS CDS002Y CDS003P CDS CDS004S CDS004WV CDS CDS006S CDS CDS DCT21A DCT21TA DCT24A DCT24TA DIL E E E EC ED24A EM ER21B ER23B ERGAR ERGAR ERGAR ERGAR ERGAR ERGB ERGB ERGB ERGC ERGC ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGF ERGH ERGH ERGH ERGH AR08005, rev date 06/

116 Products by model Products by Model (continued) ERGH ERGH ERGH ERGH ERGH ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGIR ERGM ERGM ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGN ERGR ERGR ERGR ERGR ERGR ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS ERGS EV EXGF24D EXGF24LLD EXGF24LL2D EXGF24MMD EXGF24MM2D EXGF24SS2D EXGF24SS2D EXGF24XLD EXGF24XL2D EXGF24XSD EXGF24XS2D EXLLD EXMMD EXSSD EXXLD EXXSD EZC21A EZC21TA EZC24A EZC24TA EZF21A EZF21TA EZF24A EZF24TA EZS21A EZS21QA EZS21QTA EZS21TA EZS24A EZS24QA EZS24QTA EZS24TA FEMII008A FEMII008AT FEMII008V FEMII010A FEMII010AT FEMII010V FEMII012A FEMII012AT FEMII012V FEMII014A FEMII014AT FEMII014V FEMII016A FEMII016AS FEMII018A AR08005, rev date 06/2012

117 Products by model Products by Model (continued) FEMII018AS FEMII020A FEMII020AS FLEXII022V FLEXII02216A FLO FLO002S FLO003S FTV FTV HI HI ICF IS19A ISP ISP ISP ISP IVS IVS IVS IVS IVS IVS IVS IVS IVS KP LAP LAP MIS MIS001CP MIS001CP MIS001CP MIS MIS MIS MT020A MT020TA MT022A MT022TA NPC NPC014T OPTI & 3.1 OPTI & 3.1 OPTI & 3.1 OPTI & 3.1 PAA012CB PAA014CB PAA016CB PE PEDA008SB PEDA010SB PEDA012SB PEDA014SB PEDA016SB PIKA PIKV PLD014MIBH PR PVL PVM PVS PWR3240MH PWR3446MH QD QD RC RC09M RC RC014IT RC014M RC014MIB RC014MIBB RC014MT RC014T RC RC2012M RC2012MIB RC2012MIBB RC RC2014LB RC2014LBM RC2014LBS RC2014M RC2014MIB RC2014MIBB RC2014S RN30D S S S S S S S S S S SPC SPC SPC SPC SPC SPC SRT014MIB SRT014MIBB SS23A SS23AM SS23S SS23SM TF008O TF010O TF012L TF012L TF012O TF014L TF014L TF014O TF016L TF016L TF016O TF018L AR08005, rev date 06/

118 Products by model Products by Model (continued) TF018L (Pediatric) TF018L TF018L90 (Pediatric) TF018O TF018O90(Pediatric) TF020L TF020L TF020O TF022L TF022L TF022O TF024L TF024L TF024O TF026L TF026L TF028L TF028L TF028O TF030L TF030L TF032L TF032L TF032MH TF034L TF034L TF036L TF036L TF036MH TF038L TF038L TF040L TF2020O TF TF292901A TF2937O TF2937OA TF TF292902A TF TF293702A TF3343O TF3343OA TF3646O TF3646OA TF3646O TF3646O2A TFA TFA TFA TFA02425H TFM018L TFM020L TFM022L TFM024L TFM026L TFM028L TFM030L TFM032L TFM034L TFM036L TFVO TK TR2838L TR3240L TR3446L TR3240O TR3240OA TRF2937O TRF2937OA TRF2937O TRF2937O2A TRF3240O TRF3240OA TRF3646O TRF3646OA TRF3646O TRF3646O2A VC VC VCS VCS VCS VCS VCS VCS VEN VF VFEM VFEM VFEM VFEM VFEM VP VP VPP For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, Edwards Protection Cannulae, and ThruPort are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR08005, rev date 06/

119 For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events. Edwards, Edwards Lifesciences, the stylized E logo, Edwards Protection Cannulae, and ThruPort are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. AR07028 Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com