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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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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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