Boston Sci gets expanded CE mark for Watchman, awaits FDA nod

Boston Scientific scored an expanded indication in Europe for its Watchman device--courtesy of Boston Scientific

Boston Scientific ($BSX) got some good news for its beleaguered cardiac unit, snagging an expanded indication in Europe for its Watchman device. The tech is now approved to offer stroke-reduction treatment for patients with atrial fibrillation (AF) and an aversion to blood-thinning drugs.

Watchman is a left atrial appendage closure device, inserted in the heart to capture blood clots and treat irregular heartbeats. It has been approved in Europe since 2005, but the new indication will help reduce the stroke risk for AF patients, potentially eliminating the need for problematic anticoagulants, like warfarin, Dr. Kenneth Stein, chief medical officer of Boston Scientific's cardiac rhythm management unit, said in a statement.

The next step is getting the implant onto U.S. shelves. In July, Boston Sci completed enrollment in a confirmatory study designed to get FDA approval and now it will conduct a 6-month patient follow-up before filing with the agency.

Last quarter, the company's CRM business continued its plunge, with sales falling 8%. However, atrial fibrillation presents a huge unmet need, Stein has said, and Boston Sci is counting on Watchman to pay off once approved stateside. The device reduced the risk of stroke by 75% in a recent study, and the company is confident it can outperform drug therapies in patients with irregular heartbeats.

- read Boston Sci's release

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