I SEETHRU

MINIMAL * INCISIONS

Ergonic Minimal Incision Instrumentation.

MIVS Redefined >

ThruPort Ergonic Minimal Incision Instrumentation

*When compared to median sternotomy

THRUPORT SYSTEMS > TECHNOLOGY > TRAINING > SUPPORT

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

1-4outcomes, 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

2valve 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.

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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 THRU PATIENT SATISFACTION my smallest possible incision*.

5Patient satisfaction is improved and outcomes1-4are enhanced when the least invasive approach

possible is used in heart valve surgery. Patientbenefits of MIVS, when compared to mediansternotomy, include:

1-4,6• Shorter hospital stays and time in the ICU2• Faster return to work or routine activities

2• Less discomfort and pain1,6• Reduced blood loss

• Less surgical trauma and risk of infection1,2,6or complications

2• Improved cosmesis

As with learning any new procedural approach,there is a learning curve, resulting in additionalprocedural time and/or expenses that can be

2eliminated or minimized with experience.

*When compared to median sternotomy

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I SEE THRU UNRIVALED SUPPORT

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

my smallest possible incision.*

Edwards Lifesciences is redefining minimally invasive surgery with ThruPort Systems.

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*When compared to median sternotomy

I SEE THRU MINIMAL INCISIONS

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.

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ThruPort Ergonic Instrumentation.

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.

Ergonic Atrial Retractor

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I SEE THRU EXCELLENT VALVE EXPOSURE

Ergonic minimal incision retractors.

Unique base design for greater stability once placed

360° rotation allows for free range of movement

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

Easy, secure locking system to prevent rotation once placed

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.

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Quick and easy to assemble

Accommodates multipleaccessories

Multiple blade sizes andconfiguration tailored tofit patient anatomy

Durable construction

Low profile design

Ergonic ForcepsErgonic forceps are designed for grasping and manipulating cardiac structures during minimal incision valve surgery.

I SEE THR* THE SMALLEST POSSIBLE INCISION

Ergonic long-shafted instrumentation are ideal for minimal incision valve surgery and other less invasive procedures. Ergreplacement through the smallest possible incision.*

Ergonic long-shafted instrumentation.

Ergonic ScissorsErgonic scissors are designed to cut soft tissue during minimal incision valve surgery.

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Ergonic Needle DriversErgonic 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.

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HRU

Ergonic instrumentation is designed for comfort, durability and reliability enabling for optimal valve repair or

*When compared to median sternotomy

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

ThruPort systems Ergonic minimal incision instrumentation accessories complement the reusable instrument line

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°

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

The Ergonic suture catcher is designed to effectively snare and exteriorize suture during minimal incision valve surgery.

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I SEE THRU MORE PROCEDURAL OPTIONS

*When compared to median sternotomy

*my smallest possible incision.

Hooks Suture Catcher

Blade Holder

enabling the smallest possible incisions in minimal incision valve surgery.

The Ergonic magnetic needle retriever is designed to capture and remove needles from the surgical site.

The Ergonic chordae suture ruler is designed to measure chordae length to help surgeons create pre-measured chordae suture loops.

The Ergonic suture ring is designed to facilitate minimal incision valve surgery by allowing sutures to be organized effectively in the surgical field.

Ergonic aortic valve rongeurs are designed to grasp and remove hard materials, such as calcific plaque, from cardiac structures during minimal incision

valve surgery.

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Suture RingMagnetic Needle Retriever

Aortic Valve Rongeurs Chordae Suture Ruler

Irvine, USA | Nyon, Switzerland | Tokyo, Japan | Singapore, Singapore | São Paulo, Brazil

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, Ergonic, and ThruPort are trademarks of Edwards Lifesciences Corporation.

© 2012 Edwards Lifesciences Corporation. All rights reserved. AR07434

Edwards Lifesciences

edwards.com

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.

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 minimallyinvasive valve surgery.

• Excellent outcomes,1–4 comparable to traditional sternotomy

• Excellent visualization and a virtually bloodless, unobstructed operative field with fewerproducts 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):807-10.

2. Glower DD, et al. Mitral valve operation via Port Access versus median sternotomy. Eur J Cardiothorac Surg 1998;14 Suppl 1:S143-7.

3. B rinkman WT, et al. Aortic valve replacement surgery: comparison of outcomes in matched sternotomy and Port Access groups. Ann Thorac Surg 2010;90(1):131-5.

4. Wheatley GH III, et al. Port-access aortic valve surgery: a technique in evolution. Heart Surg Forum 2004;7:E628-31.

5. Casselman FP, et al. Mitral valve surgery can now be performed endoscopically. Circulation 2003;108 Suppl 1:II48-54.

6. W oo YJ, et al. Robotic minimally invasive mitral valve reconstruction yields less blood product transfusion and shorter length of stay. Surgery 2006;140(2):263-7.