Atritech has filed its pre-market approval application (PMA) to the FDA, which contains the results of the PROTECT AF clinical trial that began enrollment in early 2005.
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, according to the Minneapolis-based Atritech.
The company said that the trial enrolled 800 patients and was conducted in 60 centers across the U.S. and Europe.
Atritech said its Watchman LAA closure technology is designed to keep harmful sized blood clots from entering a patient's blood stream, potentially causing a stroke. The company said the Watchman device may present an alternative for patients with atrial fibrillation who may not want to take blood thinning medications for life.