Feature | Heart Valve Technology | August 04, 2016

First TAVR Device Receives European Approval to Treat Intermediate Risk Patients

Recapturable transcather aortic valve is the first-of-its-kind approved in Europe to treat intermediate risk patients as an alternative to open-heart surgery

CoreValve Evolut R, intermediate risk patients, european approval, CE mark

August 4, 2016 — Medtronic announced CE (Conformité Européenne) mark market clearnace for the self-expanding, recapturable and repositionable CoreValve Evolut R System to treat aortic stenosis patients who are at intermediate risk for open-heart surgery. The Evolut R System is the first transcatheter aortic valve replacement (TAVR or TAVI) device to obtain this expanded indication in Europe.

"The unique design of the self-expanding, supra-annular Evolut R System, coupled with its ability to be recaptured and repositioned for accurate valve placement, enables this device to be a viable treatment alternative for patients at intermediate surgical risk," said Prof. Eberhard Grube, M.D., director of the Structural Heart Program at University Hospital in Bonn, Germany. "The highly-anticipated intermediate risk indication marks an important milestone for the industry as we look to safely expand TAVI access to younger and less sick patient populations."

The new intermediate risk indication approval for the CoreValve Evolut R was based on positive clinical data from the Nordic Aortic Valve Intervention (NOTION) Trial and from a subset analysis from the CoreValve U.S. High Risk Pivotal Trial. Data from the NOTION trial showed that comparable clinical outcomes to surgery can be achieved by using CoreValve in patients who are good surgical candidates. Both datasets demonstrated excellent clinical performance for the CoreValve System with lower rates of all-cause mortality and major stroke compared to surgery. Additionally, data showed low incidences of procedural complications and superior hemodynamic performance (blood flow) compared to surgery.

The Evolut R valve is delivered through the EnVeo R Delivery Catheter System, which features an InLine Sheath that significantly reduces the profile to the lowest currently on the market (14 French equivalent, less than 1/5 inch). A smaller profile size provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route, and may minimize the risk of major vascular complications in some patients.

The CoreValve Evolut R System and the EnVeo R Delivery Catheter System are now approved for use in patients at extreme, high and intermediate surgical risk in Europe and other countries that recognize the CE mark.  The CoreValve Evolut R System was FDA-approved for commercial use in the United States in June 2015 for severe aortic stenosis patients who are at high or extreme risk for surgery.

The CoreValve Evolut R System is not approved to treat intermediate risk aortic stenosis patients in the U.S.

 

Watch the video, "CoreValve Trumps Surgical Valve Replacement," and interview with Michael Reardon, M.D., professor of cardiothoracic surgery at DeBakey Heart and Vascular Center, and chairman of the patient screening committee, CoreValve U.S. pivotal trial

 

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.

For more information: www.medtronic.com

Related Content

Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab | November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Overlay Init