Medtronic's CoreValve Evolut R TAVR System Approved by FDA

June 23, 2015—Medtronic plc announced United States Food and Drug Administration (FDA) approval and the United States launch of the new recapturable, self-expanding CoreValve Evolut R system. The repositionable Evolut R system is approved for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis patients who are at high or extreme risk for surgery.

According to Medtronic, the new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R delivery system, which features the company’s InLine sheath that significantly reduces the profile (14-F equivalent). The smaller profile size expands the population of patients that can be treated to those with smaller vessels (down to 5 mm), through the preferred transfemoral access route, which may minimize the risk of major vascular complications in some patients.

Additionally, the Evolut R increases conformability and sealing at the annulus while maintaining supra-annular valve positioning for improved blood flow and hemodynamic performance. An extended sealing skirt on the 26-mm and 29-mm valve sizes is intended to further promote valve sealing at the annulus, stated Medtronic.

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 for use in the United States. The device is also available in Europe and other countries that recognize the CE Mark.

Medtronic advised that FDA approval was supported by data on 151 patients, including the procedural and 30-day outcomes in the 60-patient Medtronic CoreValve Evolut R CE Study and the first 91 patients in the Medtronic CoreValve Evolut R United States Clinical Study. 

The initial clinical outcomes from the Evolut R CE Study, which enrolled 60 patients from six centers in the United Kingdom, Australia, and New Zealand, were presented in March at ACC.15, the 64th annual scientific session of the American College of Cardiology, in San Diego, California.

In the company’s press release, Mathew Williams, MD, who served as coprimary investigator for the United States study, commented, “In a short time, the TAVR procedure has become an established treatment option for high-risk patients with severe aortic stenosis who are unable [to] undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes. Clinical data have shown the best patient outcomes are achieved when the valve is properly positioned. The advancement of recapturability with Evolut R gives physicians more confidence during the procedure and provides advantages that are nonexistent in other TAVR systems.” Dr. Williams is Chief of Adult Cardiac Surgery and Director of Interventional Cardiology and Structural Heart at the NYU Langone Medical Center in New York, New York.