Boston Scientific (NYSE:BSX) won CE Mark approval in the European Union for expanded use of its Watchman heart device, the medical device giant announced over the weekend.
The new indication allows Boston Scientific to market the catheter-based clot-capture system to patients with atrial fibrillation who can’t be treated with warfarin and new oral anticoagulants, according to a press release.
"The expanded indication for Watchman represents a significant advance for these patients who are at high risk of stroke, but who are unable to take conventional anticoagulant therapy," cardiac rhythm management group chief medical officer Dr. Kenneth Stein said in prepared remarks. "Watchman continues to demonstrate that it is an effective therapy for preventing stroke in patients with atrial fibrillation."
The Watchman device, which is already available in 30 countries, is introduced via catheter and threaded into the heart to close off the left atrial appendage and capture any blood clots that may form there. The device aims to reduce the risk of stroke and may potentially eliminate the need for long-term use of blood-thinning medications.
In addition, the European Society of Cardiology added the Watchman device to the revised "Guidelines for Management of Patients with Atrial Fibrillation."
Boston Scientific has yet to win clearance to market Watchman in the U.S., where the company recently closed enrollment of more than 2,000 patients in its Prevail trial comparing the device with warfarin
In the trial’s multi-center randomized Protect AF arm, Boston Scientific reported a 38% risk reduction for stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy in 707 enrolled patients.
The prospective multi-center ASAP trial, the results of which were unveiled earlier this year at the Heart Rhythm Society meeting in Boston, found a 77% reduction in ischemic stroke risk associated with the device in patients who can’t tolerate the drug.
The ESC’s decision to include Watchman in its AF treatment guidelines was made based on results from the Prevail study, for which Boston Scientific has gathered the equivalent of 4,000 patient-years of follow-up, the company reported.
The Watchman device, which Boston Scientific gained in last year’s $375 million acquisition of Atritech, originally won regulatory approval in the European Union in 2005, and in some Asian countries in 2009.
The device is limited to investigational use in the U.S., where the company hopes to use the results of the Prevail studies to gain FDA approval.
BSX shares were flat on the news, gaining 1¢ to trade at $5.51 as of about 11:45 a.m., compared with a closing value of $5.50 on Friday.
