First-of-Kind Implant to Reduce Stroke in High-Risk Patients Approved

Boston Scientific announced that the Food and Drug Administration (FDA) has approved WATCHMAN Left Atrial Appendage Closure Device to reduce the risk of stroke in high-risk patients with non-valvular atrial fibrillation who are looking for an alternative to long-term warfarin therapy.

The WATCHMAN Left Atrial Appendage Closure Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke or systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacological alternative to warfarin. The WATCHMAN Device is a catheter-delivered heart implant designed to close the left atrial appendage to prevent the migration of blood clots, thus reducing the incidence of stroke and systemic embolism for higher risk patients with non-valvular atrial fibrillation.

The FDA’s approval was based on the WATCHMAN clinical program that enrolled over 2,400 patients and almost 6,000 patient-years of follow-up. The study showed that the WATCHMAN Device can be safely implanted and reduces the risk of stroke in eligible patients while allowing most patients to stop warfarin therapy. A meta-analysis of all the randomized trial data showed that the WATCHMAN Device provided similar protection against all-cause stroke and statistically superior reductions in hemorrhagic stroke, disabling stroke, and cardiovascular death vs. warfarin over long-term follow-up.

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