The Food and Drug Administration (FDA) has approved Boston Scientific's stroke prevention device as an alternative to blood thinners like warfarin to help reduce the risk of stroke in patients with non-valvular atrial fibrillation.
The device works as a filter that prevents blood clots from traveling to the brain, thereby causing a stroke; the device is positioned within the left atrial appendage. By installing this device, patients would not be required to be on blood thinners that have side effects like high risk of bleeding.
The device is available in five different sizes to match each patient's own anatomy; the frame is made of Nitinol. It has ten anchors that help the device to stay aligned and in place, while the PET mesh promotes the growth of endothelial cells.
Boston Scientific received approval from the FDA after two failed attempts; the product at the time showed complications arising from efficacy and complexity during implantation. Approval was given based on the robust WATCHMAN clinical program with numerous studies. The clinical program results showed that the device can be implanted safely and reduces the risk of stroke in patients with non-valvular atrial fibrillation, enabling them to discontinue warfarin.
The device provides patients with a comparable protection against stroke, reduction in hemorrhagic stroke, disabling stroke and cardiovascular death compared to warfarin over long term follow-up.