Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant.
The Marlborough, Mass.-based medical device maker said the Watchman FLX is designed to be easier to implant during procedures to occlude the left atrial appendage and is re-capturable and re-positionable intraprocedurally.
Watchman FLX is under limited release in Europe, with more sites slated to come on line during the second half of the year, Boston Scientific said. A European post-market registry study is also planned, the company said.
“The Watchman device has been implanted in more than 75,000 patients worldwide and we are pleased that this next-generation technology has been granted European regulatory approval so that we can offer it to patients and clinicians throughout Europe,” interventional cardiology president Kevin Ballinger said in prepared remarks. “The robust clinical evidence and successful commercial outcomes of the Watchman device to-date reinforce the value of this procedure for all appropriate patients.”
