Boston Scientific Stops Roll-Out Of Lotus Edge TAVR To Resolve Locking Problem
Executive Summary
The company is pulling the new version of its transcatheter aortic valve off of shelves in Europe after it received some reports that the device could not be fully locked, which prevents the procedure from being completed. In each of the reported cases, the patients could be treated with a different valve.
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Europe's No. 3 in the transcatheter aortic valve replacement market, Boston Scientific, has inked a $435m deal to acquire its smaller Swiss rival Symetis. The US company bats away skeptics wondering whether the transaction signals Boston Scientific's shaky faith in its own Lotus valve platform, which is currently subject of a major recall. One casualty of the acquisition will be early-stage mitral valve technology company Middle Peak Medical, which Symetis had only bought a month ago.
Boston Scientific Pulls All Lotus TAVR Systems Off Shelves
The worldwide voluntary removal comes in response to reports that the pin that connects the valve to the delivery system sometimes releases prematurely, most likely due to excess tension created during manufacturing.
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