FDA Expands Approval of CoreValve Evolut TAVR Platform


The FDA expanded approval of a self-expanding TAVR platform to include patients who are at an intermediate risk for open-heart surgery.

Medtronic plc announced on July 10 that the US Food and Drug Administration (FDA) has expanded its approval of the self-expanding CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.

According to a task force between the American College of Cardiology and the American Heart Association, patients who are at an intermediate risk for open-heart surgery have a mortality risk of >3% in the first 30 days following the procedure.

The Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial, which was presented at the 2017 American College of Cardiology meeting and published in the New England Journal of Medicine, evaluated the safety and efficacy of the TAVR procedure performed in 863 patients with the use of a self-expanding bioprosthesis compared with the surgical aortic-valve replacement (SAVR) procedure performed in 794 patients.

All patients in both groups were deemed to be at intermediate risk for surgery according to Society of Thoracic Surgeons (STS) scores: STS 4.4% for the TAVR group and STS 4.5% for the surgical group.

The TAVR procedure with the CoreValue Evolut platform met its primary endpoint of noninferiority compared with SAVR for all-cause mortality or disabling stroke (12.6% vs 14%; posterior probability of noninferiority >0.999). At 2 years, the platform also demonstrated significantly better mean aortic valve gradients (7.8 mm Hg vs 11.8 mm Hg; P <.001). SAVR, on the other hand, was associated with less aortic regurgitation, major vascular complications, and the need for permanent pacemaker implantation.

“The SURTAVI intermediate-risk randomized trial showed noninferiority for all-cause or major stroke at 2 years,” Michael Reardon, MD, professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center, told MD Magazine® in an e-mail. “Short-term benefits at 30 days included less all-stroke, less transfusion, less rant failure and less atrial fibrillation, as well as significantly faster improvement in quality of life. These outstanding results have led to FDA approval of the Evolut platform for use in intermediate-risk patients with symptomatic severe aortic stenosis.”

"Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population," Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic's Cardiac and Vascular Group, said in the company’s news release. "We are delighted to take the self-expanding CoreValve Evolut platform to more patients with aortic stenosis who can benefit from this therapy."

Medtronic’s 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 in patients with severe aortic stenosis who are at an intermediate surgical risk or greater. The platform is designed to deliver excellent valve performance for patients who are often considered to be more active than the high- or extreme-risk patients who were previously indicated for the procedure.

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