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Medtronic Gets CE Mark for Larger Sizes of CoreValve
26mm and 29mm Sizes Recapturable and Deliverable Through a 14F System
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CoreValve Evolut R
February 5, 2015 -- Two larger sizes of the CoreValve Evolut R System are now available in Europe, according to Medtronic plc (NYSE: MDT). Conformité Européene approval (CE Mark) has been granted to these new device sizes, expanding the range of patients that can be treated with this next generation TAVI platform.

The CoreValve Evolut R features the lowest delivery system available (14F equivalent) allowing transcatheter aortic valve implantation in patients with vessels as small as 5mm. The Evolut R also offers the two "R"s: Recapture and Repositioning of the valve even after it has been mostly deployed, if necessary.

The initial 23mm size of the CoreValve Evolut R System received CE Mark in September 2014. These new sizes (26mm and 29mm valves) utilize an extending skirt designed to further promote valve sealing at the annulus in order to reduce paravalvular leak.

This new generation of CoreValve (the Evolut R) is not currently available in the United States. The original CoreValve, manufactured by Medtronic plc, was first approved in June 2014 by the U.S. FDA for use in patients at high risk for surgery, although it received the European CE Mark seven years earlier and has been implanted in over 70,000 patients worldwide.

The following animation from Medtronic plc demonstrates how the CoreValve is placed and implanted:

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This week's press release from Medtronic plc follows:

Medtronic Expands Access to the Next Generation CoreValve Evolut R System with New Valve Sizes
CE Mark Approval Received for New 26 mm and 29 mm Valves

February 2, 2015 -- Minneapolis -- Medtronic plc (NYSE: MDT) today announced CE (Conformité Européene) Mark for the 26 mm and 29 mm sizes of the CoreValve® Evolut™ R System, a next generation self-expanding valve that advances performance and deliverability during transcatheter aortic valve implantation (TAVI), while providing the option to recapture (re-sheath the valve back into the catheter) and reposition (move the valve to a new position either above or below its current placement) the valve during procedures. The new larger valve sizes are delivered through a 14 French equivalent delivery system-the lowest profile on the market-allowing small vessels to be accessed, and offer an extended sealing skirt intended to further promote valve sealing at the annulus.

The 23 mm, 26 mm and 29 mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System are available in Europe and other countries that recognize the CE mark. It is not approved for commercial use in the United States, where it is currently undergoing clinical trials.

Dr. Ganesh Manoharan
Dr. Ganesh Manoharan

"The clinical experience with the Evolut R system has been exceptional. The system's optimal positioning and delivery of the valve are essential to achieve the very best clinical results in TAVI. Evolut R's low profile, positioning accuracy and enhanced sealing, all supported with the option to recapture and reposition during implantation, are a significant advance for transcatheter therapy," said Ganesh Manoharan, M.D., consultant cardiologist, Royal Victoria Hospital, co-lead for the CoreValve Evolut R CE Mark study slated for presentation at ACC.15. "Expanding the Evolut R valve size range enables physicians to bring these important advances to a much broader range of patients."

The system, which consists of the CoreValve Evolut R transcatheter aortic valve and the EnVeo™ R Delivery Catheter System, is designed for first-time positioning accuracy and also offers a new InLine™ Sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch); a smaller profile size provides a greater opportunity to treat patients with smaller vessels (down to 5.0 mm), which may minimize the risk of major vascular complications in some patients. The Evolut R valve is also anatomically designed for optimal fit and sealing, while maintaining strong hemodynamic performance.

"Expanding patient access to the CoreValve Evolut R System has been a high priority, and we know the additional valve sizes have been highly anticipated by the physician community since the launch of the 23 mm valve last fall," said Rhonda Robb, vice president and general manager of Heart Valve Therapies at Medtronic. "Over the next several months we will support heart teams through training and education, imaging and patient evaluation programs that exemplify our safe and deliberate approach to expanding patient access."

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic plc (, headquartered in Dublin, Ireland, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Reported by Burt Cohen, February 5, 2015