Boston Scientific to stop heart device sales amid regulatory challenges

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(Reuters) -Boston Scientific said on Wednesday it has discontinued sales of its heart device in the European Union and will not seek approval in the U.S. and other markets due to increased clinical and regulatory requirements.

The devices had obtained the EU’s CE-mark and were sold under the brands Acurate Prime and Acurate neo2 to restore normal blood flow in patients with severe aortic stenosis, a condition where the heart’s aortic valve is narrowed or blocked.

At least three analysts said sales of the devices, called transcatheter aortic valve replacement (TAVR), were declining in the EU after a study last year showed Acurate neo2 failed to meet the main goal of non-inferiority to other TAVR devices.

This was a “wise move in our opinion in thinking about resource management,” Citi analyst Joanne Wuensch wrote in a client note.

The company said recent discussions with U.S. and other regulators resulted in increased requirements for approvals, and the resources and investments necessary to meet them were “prohibitive”.

The requirements “included the need for a new randomized clinical trial, establishment of registries and other extensive post-market surveillance activities,” a company spokesperson told Reuters.

Heart devices such as pacemakers and stents account for a substantial portion of Boston Scientific’s revenue.

The Massachusetts-based company’s key growth drivers include its stroke prevention device, Watchman, and Farapulse, which uses short high-voltage pulses to treat certain abnormal heart rhythm conditions.

The company said it expects to meet second quarter and full-year sales and adjusted profit forecast outlook despite the anticipated financial hit from the decision.

Boston last month forecast 2025 adjusted profit per share in the range of $2.87 to $2.94.

(Reporting by Mariam Sunny in Bengaluru; Editing by Leroy Leo)