ThruPort Ergonic Minimal Incision Instrumentation

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1 I SEE MINIMAL INCISIONS * THRU Ergonic Minimal Incision Instrumentation. ThruPort Ergonic Minimal Incision Instrumentation *When compared to median sternotomy MIVS Redefined > THRUPORT SYSTEMS > TECHNOLOGY > TRAINING > SUPPORT

2 MIVS REDEFINED Today, your options for treating heart valve disease are expanded by minimally invasive techniques. Minimal incision valve surgery (MIVS) is one of the most clinically effective procedures available, offering excellent 1-4 outcomes, comparable to traditional sternotomy. Demand for MIVS approaches continues to grow, with significant benefits for both surgeons and patients alike. Through peripheral cannulation and specialized instrumentation, Edwards Lifesciences MIVS approach, enabled by ThruPort systems, offers excellent visualization of cardiac structures through a virtually bloodless, unobstructed operative field so you can repair or replace the 2 valve through the smallest possible incision*. With this approach, you can consider all isolated valve patients including reoperations and those contraindicated for traditional sternotomy because it provides safe and reproducible options for cardiopulmonary bypass, global myocardial protection, and intra-aortic occlusion. 2

3 As you and your team progress in MIVS, Edwards supports you with the broadest range of products, comprehensive team training, extensive professional education, and customizable clinical operating room support. I SEE PATIENT SATISFACTION my smallest possible incision*. THRU 5 Patient satisfaction is improved and outcomes 1-4 are enhanced when the least invasive approach possible is used in heart valve surgery. Patient benefits of MIVS, when compared to median sternotomy, include: Shorter hospital stays and time in the ICU 2 Faster return to work or routine activities 2 Less discomfort and pain 1,6 Reduced blood loss Less surgical trauma and risk of infection 1,2,6 or complications Improved cosmesis 2 1-4,6 As with learning any new procedural approach, there is a learning curve, resulting in additional procedural time and/or expenses that can be 2 eliminated or minimized with experience. *When compared to median sternotomy 3

4 I SEE UNRIVALED SUPPORT my smallest possible incision. * THRU ThruPort systems provides proven solutions that go beyond just devices; they include comprehensive team training, onsite clinical operating room support, and extensive educational platforms that are customized to enhance you and your team s current and desired skill and comfort level in performing MIVS. With ThruPort products, training, and support, you and your team can continue to expand your MIVS skills for application of future technologies. ThruPort Systems Comprehensive Team Training Cadaver lab Peer-to-peer instruction Surgical case observation Simulator training Proctored training ThruPort Systems Operating Room Support Customizable clinical support, adaptable based on the needs of you and your team Hands-on clinical support ThruPort Systems Extensive Educational Platforms In-depth education curriculum Continuing educational programs, including computer-based learning Lectures delivered by experts in the field Edwards Lifesciences is redefining minimally invasive surgery with ThruPort Systems. *When compared to median sternotomy 4

5 I SEE MINIMAL INCISIONS ThruPort Ergonic Instrumentation. THRU ThruPort Ergonic minimal incision instrumentation enables cardiac surgeons to perform intricate, minimal incision procedures with confidence. Incorporating high quality engineering, Ergonic instrumentation is crafted from stainless steel for exceptional durability, reliability, and comfort in the surgeon s hands. The Ergonic instrumentation line features a broad portfolio of products designed specifically for minimal incision aortic and mitral valve replacement or repair, in addition to other cardiac procedures. The Ergonic instruments feature unique offerings including retractors, long shafted instruments and accessory components all designed for specific procedure application and ease of use. The Ergonic instrumentation and ThruPort systems technology, along with team training and operating room support, helps you reach your professional goals with MIVS to achieve better patient outcomes. MIVS with ThruPort systems may also be performed in cardiopulmonary bypass procedures such as aortic, mitral and tricuspid valve surgery, intracardiac myxoma removal, patent foramen ovale repair, atrial septal defect, and ablative maze procedures for atrial fibrillation. 5

6 I SEE EXCELLENT VALVE EXPOSURE Ergonic minimal incision retractors. THRU Ergonic Atrial Retractor The Ergonic atrial retractor is a key tool to maneuvering through smaller incisions while improving mitral valve exposure. The Ergonic atrial retractor provides retraction of the anterior wall of the right atrium and features a tripod base for stability and 360 movement for optimal positioning. The articulating blade also allows for customized retraction based on patient anatomy and surgeon preference. Unique base design for greater stability once placed 360 rotation allows for free range of movement Easy, secure locking system to prevent rotation once placed Articulating blades offer greater exposure and visualization offering an expanded range of motion (from -10 to +30 ) Variety of interchangeable blades tailored to fit patient anatomy 6

7 Ergonic Rib Retractor The Ergonic rib retractor provides intercostal retraction for aortic and mitral valve procedures among other cardiac procedures. The low profile design helps maximize usable surgical space and features a large variety of blades and accessories to meet different surgical needs and patient anatomy. Quick and easy to assemble Accommodates multiple accessories Low profile design Durable construction Multiple blade sizes and configuration tailored to fit patient anatomy 7

8 I SEE THE SMALLEST POSSIBLE INCISION Ergonic long-shafted instrumentation. * THR Ergonic long-shafted instrumentation are ideal for minimal incision valve surgery and other less invasive procedures. E replacement through the smallest possible incision.* Ergonic Forceps Ergonic forceps are designed for grasping and manipulating cardiac structures during minimal incision valve surgery. Ergonic Scissors Ergonic scissors are designed to cut soft tissue during minimal incision valve surgery. 8

9 RU Ergonic instrumentation is designed for comfort, durability and reliability enabling for optimal valve repair or Ergonic Needle Drivers Ergonic needle drivers are designed for ideal management of needles during use in minimal incision valve surgery. The Ergonic needle drivers feature two-tone handles for easy identification in the surgical field as well as unique inserts made from Tungsten carbide or Diamondite for a more delicate grasp of the needle. Ergonic forceps, scissors and needle drivers all come in multiple configurations based on surgeon preference and patient anatomy including: Three length options for varying surgical procedures Two diameter shafts for greater visibility Multiple tip configurations and angles based on surgeon need and patient antatomy Side view *When compared to median sternotomy 9

10 I SEE MORE PROCEDURAL OPTIONS * my smallest possible incision. THRU ThruPort systems Ergonic minimal incision instrumentation accessories complement the reusable instrument line Hooks Ergonic cardiac surgery hooks are designed to retract valves and cardiac structures during minimal incision valve surgery. Available in multiple configurations to meet a wide variety of surgical needs: Lengths: 30 cm, adjustable length and sliding handle Tip options: straight, round, 45 and 90 Suture Catcher The Ergonic suture catcher is designed to effectively snare and exteriorize suture during minimal incision valve surgery. Blade Holder Ergonic blade holders are designed to hold disposable scalpel blades during minimal incision valve surgery. Handle configurations: standard and adjustable length Type: Beaver blades or carbon blades *When compared to median sternotomy 10

11 enabling the smallest possible incisions in minimal incision valve surgery. Aortic Valve Rongeurs Ergonic aortic valve rongeurs are designed to grasp and remove hard materials, such as calcific plaque, from cardiac structures during minimal incision valve surgery. Chordae Suture Ruler The Ergonic chordae suture ruler is designed to measure chordae length to help surgeons create pre-measured chordae suture loops. Magnetic Needle Retriever The Ergonic magnetic needle retriever is designed to capture and remove needles from the surgical site. Suture Ring The Ergonic suture ring is designed to facilitate minimal incision valve surgery by allowing sutures to be organized effectively in the surgical field. 11

12 MIVS REDEFINED Edwards ThruPort systems minimal incision valve surgery (MIVS) approach allows you to repair or replace the valve through the smallest incision possible* truly redefining minimally invasive valve surgery. Excellent outcomes, 1 4 comparable to traditional sternotomy Excellent visualization and a virtually bloodless, unobstructed operative field with fewer products within the incision site 2 Myocardial protection and cardiopulmonary bypass support provided via remote cannulation Ergonic minimal incision instrumentation features a variety of retractors, long shafted instrumentation and accessories to enable minimal incision valve surgery and the smallest possible incision* *When compared to median sternotomy References 1. Grossi EA, et al. Impact of minimally invasive valvular heart surgery: a case-control study. Ann Thorac Surg 2001;71(3): Glower DD, et al. Mitral valve operation via Port Access versus median sternotomy. Eur J Cardiothorac Surg 1998;14 Suppl 1:S Brinkman WT, et al. Aortic valve replacement surgery: comparison of outcomes in matched sternotomy and Port Access groups. Ann Thorac Surg 2010;90(1): Wheatley GH III, et al. Port-access aortic valve surgery: a technique in evolution. Heart Surg Forum 2004;7:E Casselman FP, et al. Mitral valve surgery can now be performed endoscopically. Circulation 2003;108 Suppl 1:II Woo YJ, et al. Robotic minimally invasive mitral valve reconstruction yields less blood product transfusion and shorter length of stay. Surgery 2006;140(2): 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. AR07434 Edwards Lifesciences Irvine, USA Nyon, Switzerland Tokyo, Japan Singapore, Singapore São Paulo, Brazil edwards.com

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