Report: Boston Scientific pauses Lotus Edge heart valve in Europe

Boston Scientific (NYSE:BSX) is reportedly pausing implantations of its next-generation Lotus Edge replacement heart valve in Europe to investigate a locking mechanism issue. Marlborough, Mass.-based Boston Scientific has implanted about 200 of the Lotus Edge transcatheter aortic valve replacements in Europe, according to Barclays analyst Matthew Taylor, encountering about a 4% rate of “some issues with [the] locking mechanism of the valve.” “In these cases (incidence rate of ~4%), the device was recaptured and a new valve was implanted with no major adverse events,” Taylor wrote today in a note to investors. The company pulled Lotus Edge from the market in Europe, where it won CE Mark approval last month, so it can figure out the problem. “Boston Scientific is initiating a voluntary removal of field inventory of the Lotus Edge valve system. During the initial launch to a limited number of European sites, we received reports that in some cases the device could not be fully locked and therefore the procedure could not be completed. In all cases, patients were successfully treated with a new valve,” the company told MassDevice.com in an emailed statement. “This action does not impact patients who have already been implanted with the device. The company is completing an evaluation to identify the root cause of the issue. Physicians are advised to use the previous generation Lotus valve system, which continues to be available in Europ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news