Boston Scientific (BSX) announced the medical device company has received a CE Mark for its Lotus Valve System, which offers alternative treatment for high-risk patients with sever aortic stenosis. The advanced transcatheter aortic valve replacement (TAVR) technology, the company claims, is “the only aortic valve device that can be assessed in its final position prior to release, while maintaining the ability for the physician to reposition or fully resheath and retrieve the valve.”
The device also has incorporated Adaptive Seal technology to limit aortic leaking, which is a proven predictor of mortality, according to a company statement.
According to the press release, “the Lotus Valve System met the primary performance endpoint for the first 60-patient cohort and was implanted successfully in all patients (60/60) with no cases of severe paravalvular regurgitation. In 76.1 percent of patients there was no corelab adjudicated paravalvular regurgitation at six months.”
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Aortic stenosis affects about 3 percent of people over age 65. From the onset of symptoms, the average survival rate is 50 percent after two years and drops to 20 percent after five years, according to the company.
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