Regulatory Hurdles for Design Changes Stall Boston Scientific’s Market Comeback
Boston Scientific is facing regulatory hurdles over its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets.
The devicemaker giant launched a global voluntary recall of all its Lotus valve devices nearly a year ago due to issues with locking mechanisms.
The company had received “reports of premature release of a pin connecting the Lotus Valve to the delivery system,” according to a Feb. 23, 2017 notice to investors. At the time, BSI expected to return its valve devices to commercial markets and clinical sites by the fourth quarter of 2017.
In its latest earnings call, however, the company confirmed the valves will remain off commercial markets until at least 2019. “Pending our ability to clear certain technical and regulatory hurdles” the new goal is to re-launch in the U.S. and EU markets in 2019, BSI said.