JenaValve Technology said today that FDA has granted breakthrough device designation for its JenaValve Pericardial TAVR.
The designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. It means that FDA will provide the Irvine, Calif.–based company with priority review and interactive communication regarding device development and clinical trial protocols.
“We are clearly encouraged by this positive decision by the FDA regarding the expedited review of our unique TAVR system for patients suffering from severe aortic regurgitation who are at high risk for surgery and for which no transcatheter valve device is labeled or approved in the U.S. We look forward to continued collaborative interactions with the FDA as we move to finalize our clinical development program,” JenaValve CEO John Kilcoyne said in a news release.
The JenaValve Pericardial TAVR System includes a bioprosthesis, with a self-expanding nitinol stent and a porcine pericardial valve. JenaValve boasts of employing what it describes as state-of-the-art tissue processing techniques. The TAVR system comes in three sizes.
Transcatheter aortic valve replacement continues to be a hot space in the medical device industry, with recent studies suggesting that TAVR overall could be a safe alternative to traditional surgery. FDA last year cleared heart valves made by TAVR leaders Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) for use in patients at low risk from open-heart surgery — an expansion of potential uses for the technology.