Boston Scientific landed the European CE Mark for its next generation of the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) device. The device is used to isolate the left atrial appendage of the heart, the place where stroke-causing blood clots tend to form in patients with non-valvular atrial fibrillation (AFib).
The technology is minimally invasive, and the new generation of the WATCHMAN FLX is designed to make implantation easier and to make it applicable to a greater range of patients. The previous generation of the device received European regulatory approval back in November of 2015.
The physician decides the orientation of the implant, and it is repositionable, allowing for any necessary corrections. The new generation of the device has an improved exterior to seal off the left atrial appendage better than the original model.
“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.”
The original WATCHMAN has been approved in the United States since 2015. This next generation, WATCHMAN FLX is an investigational device and not yet available for sale.
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Via: Boston Scientific…