FDA Approves Medtronic's CoreValve TAVR System

January 17, 2014—Medtronic, Inc. (Minneapolis, MN) announced the US Food and Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve system for patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced surgically. The CoreValve system received European CE Mark approval in 2007.

According to the company, the CoreValve system was developed to treat the broadest range of patients with severe aortic stenosis. The FDA approved the entire CoreValve platform, including the CoreValve Evolut 23-mm valve and the CoreValve 26-mm, 29-mm, and 31-mm valves. The CoreValve system is suitable for patients with native valves of nearly all sizes. It features a self-expanding nitinol frame that enables controlled delivery of the device to the diseased valve, allowing for accurate placement. All valve sizes are delivered via the 18-F transcatheter aortic valve replacement delivery system, making it possible to treat patients with difficult or small vasculature.

The company advised that the FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve United States pivotal trial, which demonstrated that the CoreValve system is safe and effective, with high rates of survival and some of the lowest rates of stroke and valve leakage reported.

The trial's coprincipal investigator Jeffrey J. Popma, MD, presented the study's first results in October at a late-breaking clinical trial session of the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California. Dr. Popma is Director of Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston, Massachusetts.

According to Medtronic, the Extreme Risk Study met its primary endpoint of death or major stroke at 1 year with a rate of 25.5%, which was 40.7% lower (P < .0001) in patients treated with the CoreValve than was expected based on a performance goal developed in partnership with the FDA. At 1 month, the rate of stroke was 2.4%, and it remained low over time, with a 1-year rate of 4.1%. Additionally, 75.6% of patients were alive at 1 year. Contemporary results through the Continued Access Study, an extension of the United States pivotal trial, demonstrated even better survival and stroke performance.

“The low rates of stroke and valve leakage with the CoreValve system—two of the most concerning complications of valve replacement, because they increase the risk of death and have a dramatic impact on quality of life—set a new standard for transcatheter valves,” commented Dr. Popma in the company's press release. “The CoreValve United States Pivotal Trial was rigorously designed and applied clinical best practices. The trial results have redefined optimal TAVR outcomes in the areas that matter most to physicians and their patients, and the results are especially remarkable, given the complex medical conditions and extreme frailty of this population.”

Medtronic noted that in the pivotal trial, the CoreValve system also achieved exceptional hemodynamics after implantation, with results similar to surgical valves. Additionally, paravalvular leak rates were low and decreased over time as the self-expanding valve conformed to the shape of a patient's annulus.

Finally, the FDA determined it will conduct a separate review of the data from the High Risk Study of the CoreValve United States Pivotal Trial, which is comparing the CoreValve system to traditional open heart surgery.