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news.Atritech has filed its pre-market approval application with the FDA. The PMA contains the results of the Protect AF clinical trial which began enrollment in early 2005.
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Protect AF evaluated the Watchman left atrial appendage (LAA) closure technology versus the current standard of care, warfarin, in patients with non-valvular atrial fibrillation at risk of stroke. The trial enrolled 800 patients and was conducted in 60 centers across the US and Europe.
Atritech’s Watchman LAA closure technology is designed to keep harmful sized blood clots from entering a patient’s blood stream, potentially causing a stroke. According to the company, the Watchman device may be a viable alternative for patients with atrial fibrillation who may not want to take blood thinning medications for life.
Jim Bullock, president and CEO of Atritech, said: “We are thrilled to have completed this expansive and important trial and delighted to be one step closer to providing patients a compelling alternative to warfarin therapy.”