Boston Scientific has received US Food and Drug Administration (FDA) approval for the Watchman left atrial appendage closure device. The Watchman device offers a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. The device will be made available to US centres involved in Boston Scientific clinical studies and additional, specialised centres as physicians are trained on the implant procedure.
Watchman 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 and 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-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.
“The Watchman device is an important step forward in stroke management for patients with atrial fibrillation,” says Vivek Reddy, director of the cardiac arrhythmia service at the Mount Sinai Medical Center, New York City, USA, and co-principal investigator of the PROTECT AF and PREVAIL studies. “We know that up to 40% of patients who are eligible for oral anticoagulation do not take it for numerous reasons, highlighting the need for additional treatment options. The Watchman device is a breakthrough treatment providing those patients who are suitable for warfarin with an implant-based alternative to long-term warfarin therapy while still reducing the risk of stroke.”
The FDA approval of Watchman is based on the Watchman clinical programme which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up. The programme provided strong evidence that the device can be implanted safely and reduces the risk of stroke in eligible patients while enabling most patients to discontinue warfarin. Additionally, a meta-analysis of all of the randomised trial data demonstrated that while ischaemic stroke reduction favoured warfarin, Watchman provided patients with a comparable protection against all-cause stroke and statistically superior reductions in haemorrhagic stroke, disabling stroke, and cardiovascular death compared to warfarin over long-term follow-up.
Watchman has been commercially available internationally since 2009 and is registered in 75 countries. More than 10,000 patients have been treated with the device.