|Boston Scientific won expanded European approval for its Lotus valve.--Courtesy of Boston Scientific|
Boston Scientific ($BSX) won expanded European approval for its Lotus transcatheter valve system, adding to the company's current aortic valve offerings and bolstering its presence in overseas markets.
The Massachusetts device giant will launch a 25-mm version of its Lotus transcatheter aortic valve implantation (TAVI) system in Europe, building on its 23-mm and 27-mm valve systems. European approval was based in part on 6-month results from the REPRISE II clinical trial for individuals with severe aortic stenosis who were too frail for traditional surgical valve replacement. Boston Scientific's Lotus valve system yielded favorable results, with only 1.1% of patients having moderate paravalvular aortic regurgitation 6 months after being outfitted with the device, the company said in a statement.
"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," Tom Fleming, vice president of Boston Scientific's Structural Heart division, said in a statement. "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 scored a CE mark for its Lotus system in October 2013 and has since touted the device's promising performance in clinical trials. In April, the company presented results from its REPRISE II study which showed that 85% of patients had no paravalvular aortic regurgitation after receiving the implant. The following month, Boston Scientific unveiled new data from an extension study that yielded similar results, showing low mortality rates and stroke rates in patients outfitted with the device.
Boston Scientific's heart could skip a beat with the regulatory nod, as it continues to push for full FDA approval of its product. The Lotus valve system is labeled as an investigational device in the U.S., restricting its use to clinical trials.
Extended approval also helps Boston Scientific stay a step ahead of its competition, as archrivals Medtronic ($MDT), Edwards Lifesciences ($EW) and St. Jude Medical ($STJ) race to the TAVR finish line. In May, St. Jude completed the first implants of its transcatheter aortic valve system, inching the company closer to stateside approval for its product. Last month, Medtronic won expanded approval for its CoreValve system for patients at high risk for open heart surgery. Only days later, Edwards Lifesciences got the regulatory green light to launch its Sapien XT device for inoperable patients with severe aortic stenosis in the U.S.
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