St. Jude Medical (NYSE:STJ) said today that it won CE Mark approval in the European Union 2 new, larger sizes of its Portico replacement heart valve.
Little Canada, Minn.-based St. Jude said the approval covers the 27mm and 29mm sizes of the Portico transcatheter aortic valve implant. The 23mm Portico version won CE Mark approval in November 2012, with the 25mm version following suit in December 2013.
“Transcatheter aortic valve replacement is a complex procedure, and feedback from physicians worldwide has continued to press upon us the fact that offering a system that provides physicians more control and a simplified procedure is important,” group president Dr. Eric Fain said in prepared remarks. “In developing our Portico valve, we took such feedback into account, designing a full portfolio of sizing to ensure physicians could comfortably rely on one device family for a range of patients.”
Implantations in a U.S. clinical trial for Portico went ahead in June, after the company in September 2014 hit pause to investigate CT scans that showed possible reduced leaflet mobility. The problem was later pegged to a subclinical layer of thrombosis on the valve’s leaflets (a similar issue prompted rival Edwards Lifesciences (NYSE:EW) to pause a trial of its Fortis TAVI in May).
“Aortic stenosis is a serious, potentially life-threatening condition for patients who are unable to receive a traditional open-heart valve transplant,” added Dr. Helge Mollmannof the Kerckhoff Heart Center in Bad Nauheim, Germany. “Transcatheter aortic valve replacement has revolutionized how we treat these patients, and by offering a complete portfolio of Portico valve sizing options, St. Jude Medical has further helped broaden the patient population that can be treated with this family of valves.”