Boston Scientific announced that its Watchman FLX left atrial appendage closure device met all safety and efficacy goals in the CHAMPION-AF study, which compared the device’s effectiveness to blood thinners in reducing stroke risk and death in patients with non-valvular atrial fibrillation.
The study, which involved 3,000 patients, demonstrated that the Watchman FLX was as effective as blood thinners in lowering the risk of stroke and death at three years. Additionally, it showed a 45% relative reduction in non-procedural bleeding risk for patients who received the Watchman FLX implant. The results were presented at the American College of Cardiology’s annual meeting and published in the New England Journal of Medicine.
Boston Scientific, a global medical device company, specializes in a range of products including cardiac rhythm management, electrophysiology, endoscopy, and neuromodulation. The company’s Watchman FLX device, approved by the FDA in 2023, is the latest iteration of its left atrial appendage closure system.
The positive results from the CHAMPION-AF study are significant for the medical device industry, as they support the use of the Watchman FLX as a potential alternative to blood thinners for stroke prevention in patients with non-valvular atrial fibrillation. This could lead to expanded indications and Medicare coverage for the device, offering a new treatment option for healthcare providers and patients.
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Source: MedTech Dive