St. Jude Medical (NYSE:STJ) said it won CE Mark approval in the European Union for the 25mm version of its Portico replacement heart valve.
The Portico device, a transcatheter aortic heart implant, is designed to be repositionable during the procedure, meaning surgeons can redeploy or retrieve the device when treating aortic stenosis.
"The Portico valve is an important part of our growing portfolio of products that treat valvular disease and heart failure. The approval of this 25 millimeter valve size will allow us to expand our footprint in the global [TAVI] market and provide a promising solution for patients with severe aortic stenosis," cardiovascular & ablation technologies president Frank Callaghan said in prepared remarks.
The 23mm Portico version won CE Mark approval in November 2012. St. Jude said it expects to get 2 more sizes on the market next year, "which will expand the eligible range of patients to those with annulus sizes ranging from 19 to 27mm," according to a press release.
Both the 23mm and 25mm Portico valves are the subjects of a U.S. clinical trial aimed at winning nods from the FDA. Results from the trials, presented in October at the Transcatheter Cardiovascular Therapeutics conference, showed a 3.6% mortality rate, 2.4% major stroke rate, 10.8% pacemaker implantation rate and 10.8% major bleeding rate after 30 days.