FDA approves Sapien XT for aortic valve-in-valve procedures

The FDA approved the Sapien XT transcatheter heart valve on Oct. 15 for aortic valve-in-valve procedures.

The device (Edwards Lifesciences) was approved in June 2014 for patients at high risk for native aortic valve replacement surgery.

Earlier in the day, Edwards released data on the Sapien XT valve at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco. After one year of follow up in the PARTNER II trial, the all-cause mortality rate was 13.4 percent, the stroke rate was 3.7 percent and the hospitalization rate was 11.8 percent.

The study included 197 patients: 97 enrolled in the valve-in-valve registry at 24 sites between June 2012 and April 2013 and 100 enrolled in the extended registry at 34 sites between May 2013 and December 2013. The mean age of patients was 78.5, while 95.4 percent had New York Heart Association Class III or IV heart failure, 70.6 percent had coronary artery disease and 49.7 percent had atrial fibrillation.

The most common procedural complications were major bleeding (14.8 percent of patients), acute kidney injury (8.2 percent), major vascular complications (3.1 percent), pacemakers (1.5 percent), need for a second transcatheter heart valve (1.5 percent) and coronary obstruction (0.5 percent).

The researchers said that valve-in-valve transcatheter aortic valve replacement is an option for patients with failing surgical bioprosthetic valves.