Atritech Files Pre-Market Approval Application for WATCHMAN LAA Closure Technology
August 18, 2008 - Atritech Inc. today said it filed its pre-market approval application (PMA) with the FDA for its WATCHMAN Left Atrial Appendage (LAA) Closure Technology, which contains the results of the PROTECT AF Clinical Trial which began enrollment in early 2005.
PROTECT AF evaluated the WATCHMAN 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 U.S. and Europe.
The first patient has been enrolled into the Continued Access Registry at Washington Hospital Center under the direction of Prof. Horst Sievert and Dr. Ron Waksman.
“The PROTECT AF Trial results are highly anticipated to all those who manage patients with atrial fibrillation, the most common sustained cardiac arrhythmia,” said Vivek Reddy, M.D., director of cardiac electrophysiology, University of Miami. “We trust the data will support the approval of the WATCHMAN technology, providing clinicians with an additional tool to manage patients with atrial fibrillation.”
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. Patients with atrial fibrillation (a heart condition that causes the upper chambers of the heart to beat too rapidly) are at a greater risk of having a stroke. Typically these patients require blood-thinning medications to prevent these clots from forming in the heart. Current medical therapy requires frequent monitoring and has diet and other drug interactions causing many patients to stop taking them. The WATCHMAN device may be an alternative for patients with atrial fibrillation who may not want to take blood-thinning medications for life, the company said.
Last year, Atritech announced the acquisition of intellectual property from ev3 Inc. (EVVV) covering left atrial appendage closure devices.
For more information: www.atritech.net