Boston Scientific will eliminate jobs after discontinuing global sales of its Acurate aortic valve replacement systems that treat the heart failure-causing condition aortic stenosis, the medtech company with a large cardiology presence in Minnesota said Wednesday.
The company is ending its pursuit of Food and Drug Administration approval for its Acurate family of valves in the United States, a spokesperson said, citing “discussions with regulators which resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets.”
The spokesperson recommended patients who already have Acurate valves continue routine follow-up care.
Boston Scientific paid more than $400 million to acquire the maker of the valves in 2017.
The decision to end the program will lead to job reductions. To reduce that impact, Boston Scientific is focused on redeploying team members “to priority programs and manufacturing areas across the company,” the spokesperson said.
The discontinuation comes after Boston Scientific revealed in October that its Acurate neo2 device failed to meet “non-inferiority criteria," an important benchmark followed by regulators. At Bernstein’s Annual Strategic Decisions Conference on Wednesday, CEO Mike Mahoney called the discontinuation “disappointing.”
“We really tried, but it’s the right decision based on increased requirements that the regulatory agencies have asked us to do in [the] E.U. to keep it on the market, and there wasn’t a clear path that made sense in the U.S.,” Mahoney said.
The spokesperson said the company does not expect to communicate the number of roles eliminated and did not comment on where they are based.