TCT: Sapien Valve-in-Valve Approved by FDA (Dr. Danny Dvir)
The FDAapproved the Sapien XT aortic valve to replace failing bioprostheses in high surgical risk patients, a move based on good 1-year survival and safety results reported here from the PARTNER II valve-in-valve registry.
Danny Dvir, MD, of St. Paul's Hospital in Vancouver, announced the approval at the end of his presentation of the results at theTranscatheter Cardiovascular Therapeutics meeting.
The registry showed a 13.4% mortality rate overall at 1 year for the Sapien XT valve, which dropped to 7.2% at 1 year in the more recent extended-registry data.
Crystal Phend reports.