Next Generation WATCHMAN FLX Stroke-Preventing Device by Boston Sci; Cleared in EU

WATCHMAN FLX Stroke-Preventing Device

Next generation of the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) device by Boston Scientific landed the European CE Mark. The objective of the device is 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 new generation of the WATCHMAN FLX is designed to make implantation easier and to make it applicable to a greater range of patients and is based on a technology that is minimally invasive. In the year 2015, November, the previous generation of the device had received European regulatory approval.

It is repositionable which gives the scope for any necessary corrections even after the physician had decided the orientation of the implant. An improved exterior to seal off the left atrial appendage better than the original model, also one of the features that sets the new generation of the WATCHMAN FLX apart.

According to the president, Interventional Cardiology, Boston Scientific, Kevin Ballinger, more than 75,000 patients worldwide have been implanted with the WATCHMAN device. With the European regulatory approval the WATCHMAN FLX can be offered to patients and clinicians throughout Europe. He further added that the robust clinical evidence and successful commercial outcomes of the WATCHMAN device till now reinstates the importance of this procedure for all patients suitable for it.

Though in the United States original WATCHMAN was approved in 2015 as well, the next generation WATCHMAN FLX is not yet available for sale as it is an investigational device.

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