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Boston Scientific Stops Roll-Out Of Lotus Edge TAVR To Resolve Locking Problem

 
• By Reed Miller

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.

Boston Scientific Corp. announced it is voluntarily removing field inventory of the Lotus Edge repositionable transcatheter aortic valve system, just weeks after launching it at select few European sites, after receiving reports that some of the devices could not be locked after deployment.

If the valve cannot be locked once it is in place in the aortic annulus, the procedure cannot be completed...

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