Marlborough medical device maker Boston Scientific said it received the CE Mark for European approval for a stroke-prevention device yet to clear U.S. regulators.
The device is the next generation Watchman FLX Left Atrial Appendage Closure treating patients with atrial fibrillation by reducing the risk of stroke.
The device has already been implanted in more than 75,000 patients worldwide, the company said in a press release.
In the U.S., the device is only an investigational device and isn’t available on the market, pending Food & Drug Administration approval.
The new device was designed to fit a wider range of patients with simple to complex anatomies. It allows for implantation flexibility to customize placement with a fully enclosed and rounded frame.Â
Physicians can fully recapture and reposition the device during procedures, the company said.
The European release will be limited, and commercialization will expand in the second half of 2019. European patients will be enrolled in a post-approval registry in the coming months.
