|St. Jude won a CE mark for its larger Portico transcatheter aortic heart valve.--Courtesy of St. Jude|
St. Jude Medical ($STJ) won a long-awaited CE mark for a larger size of its Portico transcathether aortic heart valve implant, a milestone that expands its overseas market reach and ups competitive pressures on rivals Edwards Lifesciences ($EW), Medtronic ($MDT) and Boston Scientific ($BSX).
The Minnesota device company said the new approval covers the 25-mm iteration of its Portico TAVR device, which is made of bovine pericardial tissue attached to a self-expanding stent frame. It's slated for patients who have a severe narrowing of the aortic heart valve that obstructs blood flow and for whom conventional open-heart valve replacement surgery is too risky.
Portico gained a CE mark for its 23-mm size in November 2012, though neither size has U.S. approval yet. St. Jude plans to add two more valve sizes to Portico in 2014, the company said.
Portico is connected to a patient's annulus--a ring-shaped supporting structure in the heart--and those can vary in size, so more Portico sizes means a much larger potential patient base. Also, more Portico sizes means the competition is heating up in Europe against global market leader Edwards and its Sapien valves, and Medtronic's CoreValve and Engager devices, though CoreValve is at the center of an ongoing patent fight with Edwards. Boston Scientific, meanwhile, won a CE mark for its Lotus valve implant in October.
St. Jude disclosed promising early international data in October from a test of Portico 23-mm and 25-mm valves on 83 patients with severe aortic stenosis who were at high risk for conventional valve replacement surgery. Results pointed to major benefits for most of the patients after a month, including an improvement in heart failure symptoms.
Portico is implanted through a catheter, via a small incision in the leg's femoral artery and is positioned while a patient's heart keeps beating. The technique is designed to avoid the need for a cardiopulmonary bypass machine.
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