(Reuters) -Boston Scientific said on Wednesday it has stopped global sales of its heart device and will not seek approval in geographies it is not yet available due to increased clinical and regulatory requirements.
Shares of the device maker fell 1.5% to $104.57 in premarket trading.
The devices, called transcatheter aortic valve replacement (TAVR), had obtained the European Union’s CE-mark and were sold under the brands Acurate Prime and Acurate neo2 for minimally invasive heart surgeries.
But the company said recent discussions with U.S. and other regulators resulted in increased requirements to maintain regulatory approvals in existing and new markets.
“The resources and investments necessary to meet these new requirements are prohibitive,” the company said.
The company expects to meet second quarter and full-year outlook despite the anticipated financial hit from the decision, Boston said, adding that it has not reaffirmed the outlook.
(Reporting by Mariam Sunny in Bengaluru; Editing by Leroy Leo)
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