Atritech Files Pre-Market Approval Application
Atritech Files Pre-market Approval Application for its WATCHMAN® LAA Closure Technology
FOR IMMEDIATE RELEASE:
Media Contact:
Brenda Gutzke
Atritech, Inc.
763-746-5002
bgutzke@atritech.net
Atritech Files Pre-market Approval Application for its WATCHMAN® LAA Closure Technology
Enrolls first patient in Continued Access Registry
Minneapolis (August 18, 2008) – Atritech, Inc. today announced the filing of its Pre-Market Approval Application (PMA) to the Food and Drug Administration (FDA). The PMA contains the results of the PROTECT AF Clinical Trial which 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. The trial enrolled 800 patients and was conducted in 60 centers across the United States and Europe.
“This is a significant event for our Company. 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,” remarked Jim Bullock, President and CEO. “Additionally, we have enrolled our first patient 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” commented Vivek Reddy, M.D., Director, 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 which 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 a viable alternative for patients with atrial fibrillation who may not want to take blood thinning medications for life.
Last year, Atritech announced the acquisition of intellectual property from ev3, Inc. (EVVV) covering left atrial appendage closure devices.
“Having consolidated the relevant intellectual property covering LAA closure technology, completed the PROTECT AF trial and submitted the PMA, we are very well positioned for the next stage of our company” concluded Bullock.
About Atritech
Atritech is privately held and based in Plymouth, Minnesota. Major investors in Atritech include SplitRock Partners, Prism Venture Partners, Tullis-Dickerson Partners, The Vector Group, Thoma Cressey Funds, SightLine Funds and Affinity Capital. For more information, visit www.atritech.net.
