Medtronic’s TAVR platform approved for expanded use by FDA

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The U.S. Food and Drug Administration (FDA) has approved the use of a self-expanding transcatheter aortic valve replacement (TAVR) platform on patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.

The TAVR platform, branded the CoreValve Evolut, is manufactured by Dublin-based Medtronic. The device provides improved valve performance for high-risk patients, according to a July 10 press release from the company.

At this year’s American College of Cardiology conference in March, the SURTAVI trial, which compared TAVR patients treated with the CoreValve and Evolut R Systems, yielded results suggesting the CoreValve was superior.

"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," said Michael Reardon, MD, professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center, in a statement. "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."

The CoreValve family includes the CoreValve, the CoreValve Evolut R and the FDA-approved CoreValve PRO systems, which are available in the U.S. for patients with severe aortic stenosis.

"Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population," said Rhonda Robb, vice president and general manager of the heart valve therapies business, a part of Medtronic's cardiac and vascular group. "We are delighted to take the self-expanding CoreValve Evolut platform to more patients with aortic stenosis who can benefit from this therapy."