Boston Scientific delays plans to reintroduce LOTUS valve to European market

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Plans to reintroduce the once-faulty LOTUS Edge Aortic Valve System into the European market have stalled, Boston Scientific reported Tuesday.

All LOTUS valves—used across the world in TAVR procedures—were voluntarily recalled in February by Boston Scientific due to breaks in parts of its delivery system. The company announced it expected to reintroduce the product to the market by the end of 2017, but that date has been moved to the first quarter of 2018.

Mike Mahoney, the organization’s chairman and CEO, said in a statement he and his colleagues are disappointed by the delay but need to take time to implement changes to keep LOTUS valves in line with Boston Scientific’s “rigorous internal quality standards.”

The company also announced its plans to file pre-market approval for LOTUS devices with the FDA by January 2018.