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Marlborough-based Boston Scientific Corp. (NYSE: BSX) has initiated a clinical trial to evaluate the safety and effectiveness of the Lotus Valve System, designed to treat patients with severe aortic stenosis, a condition that prevents the aorta from opening fully.
The trial, known as REPRISE III, will involve patients at high risk for surgical valve replacement who could be treated instead by the device, according to BSX. A clinical team led by Dr. Ted E. Feldman of NorthShore University HealtSystem in Evanston, Ill., implanted the first three Lotus Valve Systems this week at Evanston Hospital, BSX said.
The Lotus is the first aortic valve replacement device that can be repositioned and retrieved prior to release, according to a statement from BSX. Promising data from earlier clinical studies of the Lotus Valve System were presented last week at a conference in Washington D.C., and BSX said this trial will build on those results.
“We believe that REPRISE III, which is slated to involve more than 1,000 patients, will confirm these data and show that the Lotus Valve System has the potential to improve patient outcomes beyond what we’ve seen with first generation devices,” Feldman said in a statement.
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