News | Heart Valve Technology | January 17, 2017

Medtronic Announces CE Mark, European Launch of CoreValve Evolut R 34 MM Valve

Larger device offers treatment to patients without a previous TAVI option

Medtronic, CoreValve Evolut R 34 mm valve, TAVI, CE Mark, European launch

January 17, 2017 — Medtronic plc announced the CE (Conformité Européenne) mark and European launch of the CoreValve Evolut R 34 mm valve — the largest sized transcatheter aortic valve implantation (TAVI) system available in Europe. The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26-30 mm. This large valve segment is estimated to account for approximately 20-25 percent of the eligible European TAVI patient population. Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve.

“It’s important that patients with large aortic root anatomies can also have access to this recapturable TAVI system, which has proven to be an excellent treatment option for many patients,” said Darren Mylotte, M.D., interventional cardiologist at the University Hospitals and National University of Ireland in Galway, Ireland. “Consistent with the Evolut R platform, the 34 mm valve delivery system assists with accurate placement with the option to recapture and reposition if needed; this gives physicians great confidence that exceptional outcomes can be achieved for our patients.”

The valve is delivered through the EnVeo R Delivery Catheter System, which features an InLine Sheath. The system delivers the lowest, true delivery profile currently on the market according to Medtronic (16 Fr equivalent, approximately 1/5 inch or 1/2 cm), which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. The Evolut R System, with its self-expanding nitinol frame, is designed to fit within the native aortic valve, using its supra-annular valve position to help achieve excellent hemodynamic performance.

The CoreValve Evolut R 34 mm valve received U.S. Food and Drug Administration (FDA) approval in the United States in October 2016 for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm.

For more information: www.medtronic.com

Related Content

National Survey Of Heart Valve Patients Shows Importance Of Seeking Treatment Early
News | Heart Valve Technology | August 12, 2020
August 12, 2020 — A national survey conducted by the patient advocacy group...
CardioMech's transcatheter chordae tendineae repair system uses a catheter to attach an anchor on the mitral valve leaflet and then attaches it via a cord to the apex of the heart.

CardioMech's transcatheter chordae tendineae repair system uses a catheter to attach an anchor on the mitral valve leaflet and then attaches it via a cord to the apex of the heart.

News | Heart Valve Technology | August 05, 2020
August 5, 2020 – Minneapolis-based CardioMech AS, a medical device company developing a transfemoral, transseptally d
The Edwards Konect Resilia aortic valved conduit (AVC).
News | Heart Valve Technology | July 15, 2020
July 15, 2020 —  The U.S. Food and Drug Administration (FDA) granted clearance for the Edwards Lifesciences Corp.
The Foldax Tria surgical valve reimagines the heart valve by incorporating a new, proprietary biopolymer, what the vendor calls LifePolymer, with an innovative valve design intended to eliminate calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants. Tria is also the first heart valve to be robotically manufactured, reducing variability, enabling high precision, repeatability and better quality control.
News | Heart Valve Technology | June 23, 2020
June 23, 2020 – Heart valve start-up Foldax is looking to reinventi
SMT Enters Structural Heart Market With Acquisition of Vascular Concepts. The company's Hydra TAVR (TAVI) valve gained European CE mark clearance in June 2020.
News | Heart Valve Technology | June 19, 2020
June 19, 2020 — SMT (Sahajanand Medical Technologies Pvt.
SMT (Sahajanand Medical Technology Private Ltd.), a leading medical device company of India focused on cardiology, announced it Hydra transcatheter aortic valve replacement (TAVR) device received European CE mark approval. It is indicated for the treatment of patients diagnosed with aortic stenosis. #SMT #HYDRA #TAVR

The self-expanding SMT Hydra transcatheter aortic valve replacement (TAVR) device.

Feature | Heart Valve Technology | June 09, 2020
June 9, 2020 — SMT (Sahajanand Medical Technology Private Ltd.), a leading medical device company in India focused on
News | Heart Valve Technology | June 08, 2020
June 8, 2020 — Edwards Lifesciences Corp.
Edwards Lifesciences Pascal Tricuspid Valve Transcatheter Repair System Approved in Europe
News | Heart Valve Technology | May 18, 2020
May 18, 2020 — The Edwards Lifesciences Corp.
Key TAVR Takeaways From ACC 2020
Feature | Heart Valve Technology | April 20, 2020 | Dave Fornell, Editor
Some U.S.