Boston Scientific Granted FDA Approval for Stroke Prevention Device

Boston Scientific Granted FDA Approval for Stroke Prevention Device
The Watchman FLX can be inserted more easily than its predecessor, as well as being available in more size options. Photo courtesy of Boston Scientific.

According to iData’s latest Interventional Cardiology market report, Boston Scientific is the leading competitor in this market. Now, they have produced another innovative interventional cardiology device.

The FDA has recently approved Boston Scientific’s stroke prevention device, the Watchman FLX, making it available for sale in the US. This device follows the original edition of the Watchman, improving upon its predecessor’s design.

This device works by closing the left atrial appendage in those at risk of stroke. Other methods of stroke prevention include taking blood thinners, but these can put individuals at risk of bleeding if they suffer an internal or external injury. The Watchman FLX is recommended for those who have atrial fibrillation that is not caused by heart valve issues. For atrial fibrillation caused by heart valve issues, a device such as the Abiomed Impella may be more applicable.

The FLX builds upon the previous Watchman model by being easier to implant, as well as its ability to be re-positioned or re-captured if necessary. Its new design provides a faster, more complete seal, and more long-term stability in place.

Other new features include a rounder shape, which allows for more maneuverability of the device within the left atrial appendage. More size options are available with the new edition, meaning more patients will be able to make use of the device.

Watchman FLX Clinical Trial

A 12-month study on the effectiveness and safety of the Watchman FLX, the PINNACLE FLX study, provided promising results for the device. This study measured the performance of the new Watchman device to investigate if it is an appropriate alternative to oral anticoagulants.

Participants of this study were 400 individuals with non-valvular atrial fibrillation, who could use anti-coagulant treatments, but had reason to seek non-pharmaceutical methods. The results indicated the device met safety and efficacy standards. One week post-procedure, there was a 0.5% rate of procedure-related safety events. Implant success rate was measured at 98.8%. Twelve months after the procedure, there was a high rate of effective left atrial appendage closure.

Joe Fitzgerald, president of Boston Scientific’s interventional cardiology division, spoke on the new device, stating that:

“We’ve been very pleased with the real-world clinical outcomes and positive physician feedback for the Watchman FLX device in Europe and are excited to extend availability of this next-generation technology to patients and clinicians throughout the U.S.Our Watchman technology was the first FDA-approved LAAC device on the market and has been implanted in more than 100,000 patients worldwide, and now with the Watchman FLX device, we are taking the clinical benefits of the technology to the next level for more patients while further differentiating our structural heart portfolio in the U.S.”

Via: MassDevice


Although it was widely adopted, the original Watchman device has previously received some criticism, but the new edition hopes to provide superior safety and efficacy. The study results garnered thus far show promise for this new device. Additionally, there are two other trials currently investigating the Watchmen FLX. This recent development presents interesting implications for the future of the interventional cardiology device market.

For more information on this market, iData Research has several Cardiovascular Device Market Reports that contain detailed market analyses which are based on primary interviews with industry leaders. Each study covers Units Sold, ASPs, Market Share, Procedural Data, Revenue, Growth Rates, and Market Value for each of the market segments. Request your complimentary research summary today!

iData ResearchBoston Scientific Granted FDA Approval for Stroke Prevention Device

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