PERIPHERAL US PRODUCT

Transcription

1 PERIPHERAL US PRODUCT CATALOG July

2 TABLE OF CONTENTS DIRECTIONAL ATHERECTOMY SYSTEMS HawkOne Directional Atherectomy System TurboHawk Peripheral Plaque Excision System SilverHawk Peripheral Plaque Excision System DRUG-COATED BALLOON IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter EMBOLIC PROTECTION SpiderFX Embolic Protection Device MO.MA Ultra Proximal Cerebral Protection Device CTO DEVICES Viance Crossing Catheter Enteer Re-entry Catheter Enteer Guidewire STENTS SELF-EXPANDING STENT SYSTEMS EverFlex Self-expanding Peripheral Stent with Entrust Delivery System EverFlex Self-expanding Peripheral Stent System Protégé EverFlex Self-expanding Biliary Stent System Protégé GPS Self-expanding Peripheral and Biliary Stent System Protégé RX Self-expanding Carotid Stent System BALLOON EXPANDABLE STENT SYSTEMS Visi-Pro Balloon-expandable Peripheral Stent System ParaMount Mini GPS Balloon-expandable Biliary Stent System UNMOUNTED STENTS IntraStent DoubleStrut LD Biliary Stent IntraStent Mega LD Biliary Stent IntraStent Max LD Biliary Stent PTA BALLOONS EverCross OTW PTA Balloon Catheter Admiral Xtreme PTA Balloon Catheter Fortrex 0.035" OTW HP PTA Balloon Catheter Pacific Plus PTA Catheter OTW 0.018" Pacific Xtreme PTA Balloon Catheter OTW 0.018" NanoCross Elite 0.014" OTW PTA Balloon Catheter RapidCross PTA Rapid Exchange Balloon Dilatation Catheter Chocolate * PTA Balloon INFUSION THERAPY Cragg-McNamara Valved Infusion Catheters ProStream Infusion Wires MicroMewi Infusion Catheters SNARES Amplatz Goose Neck Snare Kit Amplatz Goose Neck MicroSnare Kit Snare Replacement Catheters GUIDEWIRES Wholey Guidewire System Babywire Double-Ended Nitinol Guidewire Nitrex Guidewire SUPPORT CATHETERS, Y-CONNECTORS & GUIDE CATHETERS TrailBlazer Support Catheter TrailBlazer Angled Support Catheter BigEasy Rotating Y-Connector Sequel Rotating Double Y-Connector Launcher Peripheral Guide Catheter BRIEF STATEMENTS & REFERENCE STATEMENTS

3 DIRECTIONAL ATHERECTOMY HawkOne Directional Atherectomy System 3

4 HawkOne Directional Atherectomy System The HawkOne device is the latest addition to Medtronic s directional atherectomy portfolio, which restores blood flow in PAD patients by removing plaque from blocked arteries. Just as the name implies, the HawkOne device is a comprehensive system that treats all morphologies, including severe calcium, and offers procedural efficiency with enhanced cutting, crossing and cleaning capabilities. Model Name Vessel Diameter Sheath Compatibility (F) Crossing Profile Working 1 Effective 2 Tip Max. Cut Packing Device 7 F HawkOne LS Standard Tip H1-LS 3.5 to F HawkOne LX Extended Tip H1-LX 3.5 to F HawkOne LS Standard Tip H1-M 3.0 to F HawkOne LX Extended Tip H1-S 2.0 to Max guidewire is for HawkOne device. 1 HawkOne Working Distal end of pre-loaded flush tool, in the proximal position, to the distal end of tip. 2 HawkOne Effective Distal end of pre-loaded flush tool, in the proximal position, to the proximal end of cutter window. 4

5 TurboHawk Peripheral Plaque Excision System The TurboHawk plaque excision system treats PAD by removing soft to moderately calcified plaque buildup in leg arteries. This second generation device uses a directional cutting blade to shave plaque from the vessel maximizing luminal gain. The plaque is captured in the nosecone and safely removed from the vessel. Product Name Vessel Diameter Sheath Compatibility 1 (F) Crossing Profile Working 2 Effective 3 Tip Max Cut Packing Device LX-C THS-LX-C 3.5 to LX-M TH-LX-M 3.5 to 7.0 7/ SX-C THS-SX-C 2.0 to SS-CL THS-SS-CL 2.0 to Max guidewire is for all TurboHawk devices. 1 Sheath Compatibility - Per the Instructions For Use, the large vessel devices with smooth cutter are compatible with 8 F sheaths. A physician survey of device usage indicated 7 F sheaths may have an Internal Diameter (ID) that will accommodate the crossing profile of the LX-M device. Data on file with manufacturer. 2 Working - distal end of strain relief to the distal end of tip. 3 Effective - distal end of strain relief to the proximal end of cutter window. 5

6 SilverHawk Peripheral Plaque Excision System The first-generation SilverHawk plaque excision system treats peripheral arterial disease (PAD) by removing soft-to-mild plaque buildup in leg arteries. SilverHawk system technology uses a directional cutting blade to shave plaque from the vessel maximizing luminal gain. The plaque is captured in the nosecone and safely removed from the vessel. Product Name Vessel Diameter Sheath Compatibility 1 (F) Crossing Profile Working 2 Effective 3 Tip Max Cut Packing Device LX-M P to 6.5 7/ MS-M P to 5.0 7/ SS+ P to EXL P to DS P to Max guidewire is for all SilverHawk devices. 1 Sheath Compatibility - Per the Instructions For Use, the medium vessel and large vessel devices are compatible with 8 F sheaths. A physician survey of device usage indicated 7 F sheaths may have an Internal Diameter (ID) that will accommodate the crossing profile of the LX-M and MS-M (non-flush tip) devices. Data on file with manufacturer. 2 Working - distal end of strain relief to the distal end of tip. 3 Effective - distal end of strain relief to the proximal end of cutter window. 6

7 DRUG-COATED BALLOON IN.PACT Admiral Drug-Coated Balloon 7

8 IN.PACT Admiral Drug-Coated Balloon The IN.PACT Admiral Drug-Coated Balloon (DCB) is a clinically proven, primary endovascular therapy that treats femoropopliteal disease, reduces interventions, and preserves future treatment options. TECHNICAL SPECIFICATIONS Paclitaxel drug dose 3.5 μg/mm 2 Excipient Balloon diameters Balloon lengths Balloon fold configuration Catheter design Catheter lengths Urea 4 mm - 7 mm Guidewire compatibility Nominal balloon pressure 40, 60, 80, 120, 150 mm* 4.0 mm: 3 Folds 5.0, 6.0 and 7.0 mm: 6 Folds Over the Wire (OTW) 80 cm and 130 cm 8 atm * NOTE: 120 mm and 150 mm lengths are not offered on the 7.0 mm diameter balloon. Usable 80 cm Usable 130 cm Balloon Diameter Balloon Recommended Introducer Sheath (F) Nominal Pressure (atm) RBP (atm) ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P ADM P

9 EMBOLIC PROTECTION SpiderFX Embolic Protection Device MO.MA Ultra Proximal Cerebral Protection Device 9

10 SpiderFX Embolic Protection Device The SpiderFX device is used to capture and remove debris that becomes dislodged during an interventional procedure. The SpiderFX device is the only embolic protection device that can be delivered over any 0.014" or 0.018" guidewire, or through any 0.035" catheter* for ease of lesion crossing. The SpiderFX device has the broadest indication among distal embolic filters. It is indicated for use in carotid arteries, coronary saphenous vein bypass grafts, and lower extremity procedures. *Lower extremity procedures. Capture Wire Delivery End Recovery End Guide Catheter/ Sheath Filter Size Target Vessel Size Wire OTW/RX Wire Diameter (in/mm) Crossing Profile (F) Diameter (F) Minimum ID (in) SPD2-US SVG & Carotid / SPD2-US SVG & Carotid 320/ / SPD2-US SVG & Carotid / SPD2-US SVG & Carotid 320/ / SPD2-US SPD2-US SPD2-US SPD2-US SPD2-US SPD2-US SVG & Carotid Lower Extremity SVG & Carotid Lower Extremity SVG & Carotid Lower Extremity SVG & Carotid Lower Extremity SVG Carotid Lower Extremity SVG Carotid Lower Extremity / / / / / / / / /

11 MO.MA Ultra Proximal Cerebral Protection Device Use the MO.MA Ultra proximal cerebral protection device to contain and remove all sizes of debris that can dislodge during interventional procedures in the carotid arteries. The Mo.Ma ultra device with double-occlusion balloon system allows for proximal embolic protection to be established prior to crossing a carotid lesion. TECHNICAL SPECIFICATIONS Balloon material Balloon marker distance Recommended guidewire Balloon occlusion range Compliant elastomeric rubber 6 cm (0.89 mm) 5-13 mm diameter (CCA prox. balloon) 3-6 mm diameter (ECA dist. balloon) Minimum Sheath Size (F) Inner Diameter of the Working Channel MUS X "/2.12mm 11

12 CTO DEVICES Enteer Re-entry System Viance Crossing Catheter 12

13 Viance Crossing Catheter The Viance catheter is designed to quickly and safely deliver a guidewire via the true lumen. The low-profile Viance catheter with its fast-spin torque handle enables the physician to find small microchannels in a lesion. It is constructed of a multiwire coiled shaft for 1:1 torque and an atraumatic distal tip designed for quick and safe guidewire delivery. Description Working Guidewire Compatibility (in) Crossing Profile (max in) Sheath Compatibility VNC-FX-150 Flexible F VNC-SD-150 Standard F Enteer Re-entry System The Enteer system, consisting of the Enteer re-entry balloon catheter and Enteer guidewire, enables the physician to reliably target the true lumen from the subintimal channel above or below the knee. The distinctive shape of the Enteer balloon causes it to self-orient within a vessel, helping provide reliable true lumen targeting without complete reliance on visualization. Due to its unique design, one flat side of the balloon orients to the true lumen when inflated. Offset exit ports are located on each flat side, allowing the guidewire to be steered through the correct port for successful re-entry. Re-entry Balloon Catheter Balloon Size (W x H X L mm) Working Guidewire Compatibility (in) Crossing Profile (max in) Sheath Compatibility ENB ATK 3.75 x 1.5 x F ENB BTK 2.75 x 1.0 x F Guidewire Description Diameter (in) Tip Reach ENW-FX Flexible ENW-SD Standard ENW-SF Stiff

14 STENTS EverFlex Self-expanding Peripheral Stent System Visi-Pro Balloon-expandable Peripheral Stent System 14

15 EverFlex Self-expanding Peripheral Stent with Entrust Delivery System The Entrust delivery system is a one handed stent delivery system with a low 5 F profile. This low profile was achieved without compromising the design of the EverFlex stent or the 0.035" guidewire compatibility. The device was engineered specifically for control and accuracy based on physician feedback during extensive interviews and procedural observations. 80 cm CATHETER LENGTH STENT SIZE COMPATIBILITY 120 cm 150 cm Diameter Recomm. Introducer Sheath (F) Guidewire (in) Recomm. Lumen Size EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD EVD

16 EverFlex Self-expanding Peripheral Stent System The EverFlex stent system is designed for flexibility and durability. It is a second generation stent indicated for use in the superficial femoral and proximal popliteal arteries (SFA/PPA), common iliac, and/or external iliac arteries. The EverFlex stent is available in sizes ranging from 20 mm to 200 mm lengths (SFA/PPA) or mm lengths (iliac). The broad size matrix, all deliverable through a 6 F catheter, provides the most appropriate single-stent fit. Peak-to-peak connection nodes disperse force uniformly enhancing durability while the spiral-cell connection and three-wave peak design optimizes flexibility. 80 cm CATHETER LENGTH STENT SIZE COMPATIBILITY 120 cm Each system includes one stent and delivery catheter system. Diameter Recomm. Introducer Sheath (F) Guidewire (in) Recomm. Lumen Size PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB N/A PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB N/A PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB N/A PRB

17 Protégé EverFlex Self-expanding Biliary Stent System The Protégé EverFlex stent system is designed for the palliative treatment of malignant neoplasms in the biliary tree. The stent is made of nitinol and comes pre-mounted on an over-the-wire delivery system. The proximal and distal ends of the stent have tantalum radiopaque markers for enhanced visibility. Unconstrained Stent Diameter Unconstrained Stent Rec. Lumen Size Usable Sheath Size (F) Guidewire Acceptance (in) Outside Diameter (in) PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB PRB Each system includes one stent and delivery catheter system. 17

18 Protégé GPS Self-expanding Peripheral and Biliary Stent System The Protégé GPS self-expanding peripheral and biliary stent system is a self-expanding nitinol stent system indicated for the common and external iliac arteries, and designed for the palliative treatment of malignant neoplasms in the biliary tree. The stent is made of a nickel titanium alloy (nitinol) and comes pre-mounted on a 6 F over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, outward force. Unconstrained Stent Diameter Unconstrained Stent Each system includes one stent and delivery catheter system. Rec. Lumen Size Usable Sheath Size (F) Guidewire Acceptance (in) Outside Diameter (in) SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB Biliary Only SERB SERB SERB SERB SERB SERB SERB SERB SERB SERB

19 Protégé RX Self-expanding Carotid Stent System The Protégé RX stent system is designed for carotid artery stenting. The nitinol stent comes premounted on a 6 F, 0.014" rapid exchange delivery system. The proximal and distal ends of the stent have tantalum radiopaque markers for enhanced visibility. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency of the vessel. Unconstrained Stent Diameter Unconstrained Stent Rec. Lumen Size Usable Catheter Sheath Size (F) Guidewire Acceptance (in) Straight SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX SECX Tapered SECX /6 30 ( )-( ) SECX /6 40 ( )-( ) SECX /7 30 ( )-( ) SECX /7 40 ( )-( ) Each system includes one stent and delivery catheter system. 19

20 Visi-Pro Balloon-expandable Peripheral Stent System The Visi-Pro stent system is indicated for use in the common and external iliac arteries. It is made from a stainless steel tube that is cut into an open lattice design and has tantalum radiopaque markers at the proximal and distal ends of the stent. The stent is mounted (crimped) onto a tightly folded balloon catheter and expanded and deployed by inflating the balloon. 80 cm CATHETER LENGTH STENT SIZE BALLOON COMPATIBILITY 135 cm Diameter Balloon Rec. Introducer Sheath (F) Guidewire (in) PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB * 0.035" PXB PXB " PXB PXB " PXB PXB " PXB PXB " PXB PXB " PXB PXB " PXB PXB " PXB PXB " *6 F = I.D. Each system includes one stent and delivery catheter system. 20

21 ParaMount Mini GPS Balloon-expandable Biliary Stent System The ParaMount Mini GPS stent system is designed for high visibility and is compatible with a 6 F and 7 F guide catheter. The proximal and distal ends of the stent have tantalum radiopaque markers for enhanced visiblity. Expanded Stent Diameter Expanded Stent Balloon Recommended Guide Catheter / Sheath Size Guidewire Acceptance (in) PMB / PMB / PMB / PMB */ PMB */ PMB */ PMB / PMB / PMB / Expanded Stent Diameter Expanded Stent Balloon Recommended Guide Catheter / Sheath Size Guidewire Acceptance (in) PMB / PMB / PMB / PMB */ PMB */ PMB */ PMB / PMB / PMB / *6 F = I.D. Each system includes one stent and delivery catheter system. 21

22 IntraStent Biliary Stent System The IntraStent biliary stent system is made up of unmounted large diameter stents designed for flexibility, strength and a low profile. These stents are designed to be manually crimped onto a non-compliant PTA balloon catheter that is indicated for the biliary stent expansion. UNEXPANDED STENT SIZE EXPANDED STENT SIZE Diameter Diameter IntraStent DoubleStrut LD Biliary Stent S15-16 ( ) , 10, 11, S15-26 ( ) , 10, 11, S15-36 ( ) , 10, 11, S15-56 ( ) , 10, 11, S15-76 ( ) , 10, 11, IntraStent Mega LD Biliary Stent S17-16 ( ) , 10, 11, S17-26 ( ) , 10, 11, S17-36 ( ) , 10, 11, IntraStent Max LD Biliary Stent S18-16 ( ) S18-26 ( ) S18-36 ( )

23 PTA BALLOONS Chocolate * PTA Balloon Catheter Fortrex OTW HP PTA Balloon Catheter 23

24 EverCross OTW PTA Balloon Catheter The EverCross balloon catheter is an 0.035" balloon that is specially designed for optimal pushability and trackability. The EverCross balloon catheter delivers both superior performance and a broad range of balloon sizes. Usable 40 cm Usable 80 cm Usable 135 cm Balloon Diameter Balloon Recomm. Introducer Sheath (F) Nominal Pressure (atm) - AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W (continued on next page) - AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W AB35W RBP (atm) 24

25 Admiral Xtreme PTA Balloon Catheter OTW 0.035" Treat longer PAD lesions above the knee with Admiral Xtreme PTA balloon catheter. Offered in 250 and 300 mm lengths, with 0.035" guidewire compatibility, featuring large inflation lumen for rapid inflation and deflation. TECHNICAL SPECIFICATIONS Catheter design Balloon material Balloon coating Balloon marker Usable shaft lengths Shaft diameter Over the wire (OTW) Flexitec Xtreme Hydrophilic 2 swaged (zero profile) Platinum Iridium 80, 130 cm 5 F - 6 F Guidewire compatibility ORDER INFORMATION Usable 80 cm Usable 130 cm Balloon Diameter Balloon Recom. Introducer Sheath (F) Nominal Pressure (atm) ADM ADM ADM ADM ADM ADM ADM ADM ADM ADM ADM ADM ADM ADM RBP (atm) 25

26 Fortrex 0.035" OTW HP PTA Balloon Catheter The Fortrex PTA balloon is the next-generation high pressure solution for AV access, and it is also intended for use in the peripheral vascular system. Engineered specifically for peak performance at rated burst pressure, the Fortrex balloon offers the deliverability, predictability and procedural efficiency desired by physicians. Usable 40 cm Usable 80 cm Usable 135 mm Balloon Diameter Balloon Nominal Pressure (atm) Rated Burst Pressure (atm) Recommended Introducer Sheath (F) A35HPV A35HPV A35HPV mm 20 mm A35HPV A35HPV A35HPV mm 40 mm A35HPV A35HPV A35HPV mm 80 mm A35HPV A35HPV A35HPV mm 100 mm A35HPV A35HPV A35HPV mm 20 mm A35HPV A35HPV A35HPV mm 40 mm A35HPV A35HPV A35HPV mm 80 mm A35HPV A35HPV A35HPV mm 100 mm A35HPV A35HPV A35HPV mm 20 mm A35HPV A35HPV A35HPV mm 40 mm A35HPV A35HPV A35HPV mm 80 mm A35HPV A35HPV A35HPV mm 100 mm A35HPV A35HPV A35HPV mm 20 mm A35HPV A35HPV A35HPV mm 40 mm A35HPV A35HPV A35HPV mm 80 mm A35HPV A35HPV A35HPV mm 100 mm A35HPV A35HPV A35HPV mm 40 mm A35HPV A35HPV A35HPV mm 80 mm A35HPV A35HPV A35HPV mm 100 mm A35HPV A35HPV A35HPV mm 40 mm A35HPV A35HPV A35HPV mm 80 mm A35HPV A35HPV A35HPV mm 40 mm A35HPV A35HPV A35HPV mm 80 mm A35HPV A35HPV A35HPV mm 40 mm A35HPV A35HPV A35HPV mm 80 mm

27 Pacific Plus PTA Catheter OTW 0.018" Realize more access options when you choose the Pacific Plus PTA catheter OTW 0.018", with its versatile shaft lengths. The proprietary balloon technology allows for enhanced crossing for treating lesions and the improved shaft design speeds deflation following treatment. TECHNICAL SPECIFICATIONS Catheter design Over the Wire (OTW), Coaxial Shaft Usable shaft lengths 90, 130, 180 cm Balloon material Proprietary Shaft diameter 4 F Balloon coating Hydrophilic Maximum guidewire compatibility Balloon marker 2 Swaged, Platinum Iridium Usable 90 cm Usable 130 cm Usable 180 cm Balloon Diameter Balloon Minimum Sheath Inner Diameter (F) Nominal Pressure (atm) PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP PCP RBP (atm) 27

28 Pacific Xtreme PTA Balloon Catheter OTW 0.018" Treat longer lesions with the Pacific Xtreme PTA balloon catheter OTW 0.018" that is offered in lengths from 150 to 300 mm. These balloons are well suited for use in treating long lesions in the femoral and popliteal vessels. TECHNICAL SPECIFICATIONS Catheter design Over the wire (OTW), coaxial shaft Balloon material Flexitec Xtreme Balloon coating Hydrophilic Balloon marker 2 swaged, Platinum Iridium Usable shaft lengths 90, 130 cm Shaft diameter 3.9 F 4.2 F Guidewire compatibility Usable 90 cm Usable 130 cm Balloon Diameter Balloon Recom. Introducer Sheath (F) Nominal Pressure (atm) PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU PCU AMP AMP / RBP (atm) 28

29 NanoCross Elite 0.014" OTW PTA Balloon Dilatation Catheter Go deeper into the anatomy and across difficult lesions with NanoCross Elite balloon catheter. Its seamless design from balloon to tip offers efficient energy transfer. Usable 90 cm Usable 150 cm Balloon Diameter Balloon Recomm. Introducer Sheath (F) Nominal Pressure (atm) AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W (proximal) / 1.5(distal) AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W (proximal) / 2.0(distal) AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W (proximal) / 2.5(distal) AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W (proximal) / 3.0(distal) AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W (proximal) / 3.5(distal) AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W AB14W RBP (atm) 29

30 RapidCross PTA Rapid Exchange Balloon Dilatation Catheter Reach for the RapidCross PTA rapid exchange balloon dilatation catheter when you need to reach more distal lesions in the small vessels below the knee. This catheter is the Medtronic solution for a rapid exchange balloon with 0.014" guidewire capability. Usable 90 cm Usable 170 cm Balloon Diameter Balloon Recomm. Introducer Sheath (F) Nominal Pressure (atm) A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX (proximal) / 1.5(distal) A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX (proximal) / 2.0(distal) A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX (proximal) / 2.5(distal) A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX (proximal) / 3.0(distal A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX A14BX (proximal) / 3.5(distal) RBP (atm) 30

31 Chocolate * PTA Balloon Catheter Minimize vessel trauma, dissections and the need for bailout stenting above or below the knee with the Chocolate * PTA balloon. The balloon s unique nitinol constraining structure creates pillows and grooves that provide a predictable, uniform and atraumatic dilatation. Usable 80 cm Balloon Diameter Balloon *Third party brands are trademarks of their respective owners. Catheter Guidewire (in) Introducer Sheath (F) Nominal Pressure (atm) CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " CB OTW " RBP (atm) 31

32 INFUSION THERAPY Cragg-McNamara Valved Infusion Catheters 32

33 Cragg-McNamara Valved Infusion Catheter Cragg-McNamara catheters have radiopaque markers proximal and distal to the infusion segments. A Cragg-MicroValve at the distal tip provides end-hole occlusion. Cragg-McNamara catheters are available in a wide variety of side-hole infusion lengths. Diameter Usable Infusion Max. Guidewire (in)

34 ProStream Infusion Wire The ProStream wire is a 0.035" diameter, single lumen, closed-end wire that can be used alone or coaxially to treat two areas simultaneously, anywhere below the knee. Diameter (in) Usable Infusion MicroMewi Infusion Catheter The MicroMewi catheter is a single lumen, 2.9 F flexible catheter that is introduced over an 0.018" guidewire for delivery of pharmaceutical agents directly into a thrombosed segment. Diameter (F) Usable Infusion Max. Guidewire (in)

35 SNARES Amplatz Goose Neck Snare Kit 35

36 Amplatz Goose Neck Snare Kit The Amplatz Goose Neck snare kit is intended for use in the retrieval of atraumatic foreign bodies. Each kit contains one snare and one catheter. The snare is constructed of nitinol cable and a gold-plated tungsten loop. Because of the snare s preformed loop and superelastic construction, it can be introduced through catheters without risk of snare deformation. The snare catheter has a platinum-iridium radiopaque marker band. The Amplatz Goose Neck snare kit is intended for the cardiovascular and peripheral vascular systems. Loop Diameter Snare Catheter Size (F) Catheter GN GN GN GN GN GN GN GN GN Amplatz Goose Neck MicroSnare Kit The Amplatz Goose Neck kit is intended for the coronary and peripheral vascular system and the extra-cranial neurovascular anatomy. Loop Diameter Snare Catheter Size (F) Catheter SK SK SK SK SK SK

37 Snare Replacement Catheters Each Amplatz Goose Neck snare kit contains one snare and one catheter. The snare replacement catheters have a platinum-iridium radiopaque marker band. The Amplatz Goose Neck snare kit is intended for the cardiovascular and peripheral vascular systems. Catheter Outside Diameter (F) Catheter MC MC MC MC Each system includes one snare, one catheter, one introducer, and one torque device. 37

38 GUIDEWIRES Wholey Guidewire System Nitrex Guidewire 38

39 Wholey Guidewire System The Wholey guidewire is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures, Wholey guidewires provide enhanced torqueability and lubricity, alllowing interventionalists to approach challenging cases with confidence. Description Stiffness Profile Tip Style Size Outer Dia. (in) Size Quantity WWFS35145 Floppy Tip, Extension Compatible Floppy Straight/Shapeable /Pkg WWFS35175 Floppy Tip, Extension Compatible Floppy Straight/Shapeable /Pkg WWFS35260 Floppy Tip, Exchange Floppy Straight/Shapeable /Pkg WWFS35300 Floppy Tip, Exchange Floppy Straight/Shapeable /Pkg WWIJ35145 Modified J Tip, Extension Compatible Intermediate Modified J/Shapeable /Pkg WWIJ35175 Modified J Tip, Extension Compatible Intermediate Modified J/Shapeable /Pkg WWIJ35260 Modified J Tip, Exchange Intermediate Modified J/Shapeable /Pkg WWIJ35300 Modified J Tip, Exchange Intermediate Modified J/Shapeable /Pkg WWSS35145 Standard Tip, Extension Compatible Standard Straight/Shapeable /Pkg WWSS35175 Standard Tip, Extension Compatible Standard Straight/Shapeable /Pkg WWSS35260 Standard Tip, Exchange Standard Straight/Shapeable /Pkg WWSS35300 Standard Tip, Exchange Standard Straight/Shapeable /Pkg WWES35001 Extension System Standard Straight/Shapeable /Pkg WWTD35001 Kendall Torque Device NA NA 0.025"-0.038" 10/Pkg Babywire Nitinol Guidewire The Babywire guidewire assists in the placement of initial catheters and exchange of small vessel anatomy. Babywire guidewires are straight nitinol guidewires designed with double-ended round tips and flexible ends. Babywire guidewires are kink resistant and provide 1:1 torque. (10 / Package) Diameter (in) BW BW

40 Nitrex Guidewires The 0.014" and 0.018" Nitrex guidewires are intended for use in the peripheral and coronary vasculature. The and Nitrex guidewires are indicated for use in the peripheral vasculature. Nitrex guidewires are kink resistant and provide 1:1 torque. They are constructed of a superelastic nitinol core wire with a gold-plated tungsten coil for enhanced visualization. The wires have proprietary silicone coating for ease in placement. A torque device is packaged with and Nitrex guidewires. (3/Package)* Diameter (in) Tip Style Tip Tip Shape Tip Angle ( ) N INT 5 A 15 N INT 5 A 15 N INT 5 A N INT 5 S 0 N INT 7 S 0 N STD 2 S 0 N INT 5 A 15 N STD 2 S 0 N INT 5 A 15 N Flop 20 A 15 N STD 2 S 0 N INT 5 A N INT 8 A 15 N STD 2 S 0 N INT 8 A Flexible Shaft N INT 15 S 0 N INT 15 A 45 N INT 15 S 0 N INT 15 A 45 N INT 15 S Stiff Shaft N INT 9 S 0 N FLOP 14 A 45 N INT 9 S 0 N FLOP 14 S 0 N INT 9 S 0 N STD 4 A 45 N FLOP 14 S 0 N STD 4 A 45 N INT 9 S 0 N INT 9 S 0 N INT 9 S 0 *Torque devices included on and wire sizes. 40

41 SUPPORT CATHETERS, Y-CONNECTORS, AND GUIDE CATHETERS TrailBlazer Angled Support Catheter 41