FDAnews Device Daily Bulletin

Boston Scientific Puts Hold on Lotus Edge Heart Valve Launch in Europe

Nov. 2, 2016

Boston Scientific is pausing utilization of its Lotus Edge replacement heart valve in Europe to investigate a locking mechanism issue.

“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 said.

Boston Scientific is conducting an evaluation and is recommending physicians to use the previous generation Lotus valve system. — Cynthia Jessup

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