United States Clinical Study Begins For Medtronic's CoreValve Evolut R Recapturable TAVR System

September 10, 2014—Medtronic, Inc. announced the first procedures in the United States in the CoreValve Evolut R clinical study. The study will evaluate the safety and effectiveness of the new Medtronic CoreValve Evolut R system, which is an investigational self-expanding valve and 14-F-equivalent delivery system.

According to Medtronic, the prospective study will enroll up to 250 patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement at up to 25 sites in the United States. The primary endpoints are all-cause mortality and disabling stroke at 30 days, as well as device success rate at 24 hours to 7 days. Secondary endpoints include recapture success rate, when attempted, and hemodynamic performance.

On September 3, Medtronic announced that the CoreValve Evolut R transcatheter valve system received European CE Mark approval earlier this month for transcatheter aortic valve replacement (TAVR). In the United States, the CoreValve Evolut R system is limited to investigational use only.

Medtronic stated that the CoreValve Evolut R system is designed to advance deliverability and valve performance while providing the option to recapture and reposition the CoreValve Evolut R valve during deployment, if needed, while performing TAVR.

The system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R delivery system. The new valve is anatomically designed to increase conformability at the annulus for optimal annular fit and sealing while maintaining supra-annular valve position for improved blood flow and hemodynamic performance. The EnVeo R delivery system offers a new InLine sheath that significantly reduces the profile of the catheter shaft to 14-F equivalent. The EnVeo system's 1:1 delivery response is designed to provide first-time valve placement accuracy during deployment, advised Medtronic.

Mathew Williams, MD, serves as coprimary investigator for the study. Dr. Williams is Chief of Adult Cardiac Surgery and Director of Interventional Cardiology and Structural Heart at New York University Langone Medical Center in New York, New York.

In Medtronic’s press release, Dr. Williams commented, “In clinical trials and real-world use, patients treated with the current CoreValve system have experienced high rates of survival, low rates of stroke, and improved quality of life. This study will build on that strong legacy by evaluating the next generation of this successful system, a recapture-enabled valve with the lowest-profile delivery system.”

Jeffrey J. Popma, MD, added, “The Evolut R system is designed to provide physicians with greater confidence throughout the procedure and a back-up plan in case the valve isn't positioned correctly at first. While the delivery system is designed to enable accurate positioning on the first attempt, the added assurance of recapturability to a commercially proven valve will be a significant advance for TAVR therapy.”

Dr. Popma, who served as national coprincipal investigator of the original CoreValve United States pivotal trial, is Director of Interventional Cardiology at the Beth Israel Deaconess Medical Center and a professor of medicine at Harvard Medical School in Boston, Massachusetts.

US Food and Drug Administration approval of the original CoreValve system for patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced surgically was announced in January 2014. The CoreValve system received European CE Mark approval in 2007.