Boston Scientific's ($BSX) Watchman device reduces stroke risk in patients who can't take oral anticoagulants, a development that could help push the device toward U.S. availability, according to a study released Friday.
The company studied 150 patients with atrial fibrillation (an irregular heartbeat) who are unable to take the anticoagulant warfarin through traditional means. By implanting them with Watchman and administering dual antiplatelet therapy, the researchers found that the treatment reduced stroke risk by 75% after 6 months.
Watchman is already available in Europe and Latin America, and Boston Sci is soon to start enrolling patients in a U.S. trial, aiming to get FDA approval this year. And the company sees a big market for the device. About 15 million people worldwide have atrial fibrillation, according to the Boston Sci, and patients with contraindications to oral drugs have few options.
"This is one of our growth initiatives," Kenneth Stein, the company's chief medical officer, told The Wall Street Journal. "We see this as a major growth market in terms of meeting a global unmet medical need."
And he's probably right: St. Jude ($STJ) reported a 13% increase in atrial fibrillation devices sales in the first quarter of this year, and Medtronic's ($MDT) successful cardiac ablation system might be vulnerable after facing safety concerns from the FDA over the past year.
- read Boston Sci's release
- get more from WSJ (sub. req.)