FDA Approves Intermediate-Risk Indication for Medtronic's CoreValve Evolut TAVR Platform

July 10, 2017—Medtronic announced expanded US Food and Drug Administration (FDA) approval of the company's self-expanding CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform to include patients with symptomatic severe aortic stenosis who are at intermediate risk for open surgical aortic valve replacement (SAVR).

Medtronic noted that patients who are at intermediate risk for open surgery have a risk of mortality ≥ 3% at 30 days after the procedure. The risk assessment is determined by a heart team (including an interventional cardiologist and cardiac surgeon), in combination with the Society of Thoracic Surgeons (STS) score and other factors, such as comorbidities, frailty, previous surgical intervention, and disabilities.

In the company's announcement, Michael Reardon, MD, commented, "As evidenced by the landmark SURTAVI trial, the CoreValve Evolut platform is well suited for the intermediate-risk patient population due to its supra-annular design for unsurpassed hemodynamics, low rates of mortality and disabling stroke, earlier improvement in quality of life, fast functional recovery times, and short hospital stays. It's important to consider that in the first 30 days, patients treated with TAVR showed functional improvements and lower rates of stroke than the surgical patients in the study." Dr. Reardon is a Professor of Cardiothoracic Surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center in Houston, Texas.

In March, Dr. Reardon presented the clinical data from SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) at ACC.17, the American College of Cardiology's 66th annual scientific session in Washington, DC. The SURTAVI data were published simultaneously online by Dr. Reardon, et al in The New England Journal of Medicine (2017;376:1321–1331).

The global SURTAVI trial evaluated intermediate-risk patients and compared 863 TAVR patients treated with the CoreValve and Evolut R systems (STS: 4.4%) with 794 surgical patients (STS: 4.5%). The company noted that against the strongest surgical performance (compared with predicted surgical risk of mortality) seen to date in a randomized trial, the CoreValve Evolut platform met its primary endpoint of noninferiority compared with surgery in all-cause mortality or disabling stroke (12.6% for TAVR vs 14% for SAVR; posterior probability of noninferiority > .999). The CoreValve Evolut platform also demonstrated significantly better mean aortic valve gradients (7.8 vs 11.8 mm Hg; P < .001) at 2 years. SAVR was associated with less aortic regurgitation, major vascular complications, and need for permanent pacemaker implantation.

According to the company, the CoreValve Evolut platform is designed to deliver excellent valve performance for these patients who are often considered to be more active than high- or extreme-risk patients previously indicated for the procedure; additionally, the device has demonstrated hemodynamic performance superior to SAVR.

Medtronic stated that the CoreValve Evolut platform consists of the CoreValve, CoreValve Evolut R, and the recently FDA-approved CoreValve Evolut Pro systems, which are available for use in the United States with severe aortic stenosis patients at an intermediate or greater surgical risk. The CoreValve Evolut Pro system is currently not approved for commercial use outside of the United States.