Boston Scientific Receives CE Mark for Next Generation WATCHMAN FLX
Boston Scientific announced they've received European CE Mark for the next generation WATCHMAN FLX Left Atrial Appendage Closure Device.
The new WATCHMAN FLX was developed for straightforward implementation in simple and complex patient anatomies, opening the device up to a wider range of patients. Additionally, the flexibility around implantation with the WATCHMAN FLX allows a customized placement with a fully enclosed and rounded frame, offering physicians the ability to fully recapture and reposition the device during the procedure.
The WATCHMAN devices are meant to reduce the risk of stroke in people with non-valvular AF.
WATCHMAN Implantation Technique
"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," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "The robust clinical evidence and successful commercial outcomes of the WATCHMAN device to-date reinforce the value of this procedure for all appropriate patients."
WATCHMAN has yet to be cleared by the FDA and is considered an investigational device in the U.S.
In Europe, Boston Scientific has begun a limited market release of the device and expects to expand commercialization to additional sites in the second half of 2019.