Medtronic unveiled new 30-day data for its recapturable and repositionable transaortic valve replacement at this year’s Transcatheter Cardiovascular Therapeutics (TCT) meeting. The device earned FDA approval in June last year.
Once placed, the CoreValve Evolut R can be retrieved and moved in reverse using the catheter that delivered it. Since its approval, Medtronic has recalled nearly 7,000 units of the EnVeo system used to place the device and revamped the instructions for deploying the device in order to cut down on blood vessel damage.
The devicemaker presented positive data from two separate registries at TCT. They both sought to evaluate 30-day outcomes in “real-world” aortic stenosis patients.
The FORWARD study is a single-arm, prospective study designed to confirm the results reported in the CE study of the Evolut R. Medtronic reported data from the first 300 patients with severe aortic stenosis enrolled at 60 sites around the world, according to the statement. This includes an “exceptional” survival rate of 98% and a low rate of all strokes--3%--at 30 days after treatment. They also had better hemodynamic performance, low incidence of major vascular complications and no reports of thrombosis at 30 days.
“As patient follow-up continues at one, two and three-years post-implant, we look forward to seeing how the features of the Evolut R System can address everyday clinical needs in various severe aortic stenosis patient scenarios worldwide,” said Dr. Eberhard Grube, director of the Structural Heart Program at University Hospital in Bonn, Germany, and co-principal investigator of the FORWARD study, in the statement.
The second tranche of data came from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry. An analysis of 9,616 patients who received the Evolut R showed a high survival rate, 96% and a low rate of all strokes, 3%, at 30 days post-treatment. In addition to improved hemodynamic performance and low rates of major vascular complications, patients in this study stayed in hospital a median of four days postprocedure and were more likely to return home after treatment rather than to a nursing home or rehab site.
"The latest FORWARD and TVT Registry results presented today further builds upon the growing body of global evidence supporting our self-expanding TAVR systems as safe and effective treatment options," said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business in Medtronic's Cardiac and Vascular Group, in the statement.