FDA approval expands access of CoreValve to high-risk patients

The FDA has today approved the use of the self-expanding CoveValve transcatheter valve for patients with severe aortic stenosis who are at high risk for surgery.

The approval follows less than 3 months after the results of the CoreValve High Risk study were presented at the American College of Cardiology Scientific Sessions and showed superiority of transcatheter aortic valve replacement with the CoreValve vs. open valve replacement in 1-year survival among high-risk surgical candidates (85.8% vs. 80.9%; P=.04 for superiority). Based on the strength of the trial’s results, the FDA decided to approve the expanded indication for the CoreValve without needing an independent device advisory panel review.

David H. Adams

“This rigorous trial has defined a new standard for transcatheter valve performance, with superiority results that give physicians even more confidence in making TAVR treatment decisions,” David H. Adams, MD, chair of the department of cardiothoracic surgery at the Mount Sinai Hospital, New York, and national co-principal investigator of the CoreValve US Pivotal Trial, said in a press release. “With this approval, we can treat more patients due to the broad range of CoreValve sizes, and we have an option compared to surgery that provides a greater chance for a longer life while minimizing the risk of stroke.”

The approval applies to the entire CoreValve platform, including the 23 mm, 26 mm, 29 mm and 31 mm valve sizes, which can all be delivered through its 18F delivery system, the smallest commercially available for the TAVR procedure, according to the release. The self-expanding frame allows for controlled deployment, which enables physicians to accurately place the valve inside a patient's original valve, while conforming the implant to the native annulus.

To date, the CoreValve has been implanted in more than 60,000 patients in more than 60 countries.