Boston Scientific (NYSE:BSX) is heading straight to market with its 25 mm Lotus transcatheter aortic valve after winning CE Mark approval this week, the company announced.
Boston Scientific already sells the 23 mm and 27 mm valves in Europe, and the company expects the 25 mm model to help doctors make more precise selections in valve sizing.
"We believe the addition of the 25 mm valve size will offer our Lotus users an important treatment option for patients with severe aortic valve disease," Boston Scientific vice president and structural heart general manager Tom Fleming said in prepared remarks. "Commercializing the 25 mm valve only 7 months after our initial launch of the Lotus Valve System demonstrates our commitment to advancing therapies and improving patient outcomes."
Boston Scientific won initial CE Mark for the Lotus system in October 2013, and the company has some serious rivals in the market. Industry titans Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) have had valves in Europe for years and are also competing for share in the U.S., where Boston Scientific has yet to win FDA approval.