May 28 (Reuters) - Boston Scientific ( BSX ) 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 ( BSX ) 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.