News | August 18, 2008

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

Related Content

FDA clears Claret Medical Sentinel embolic protection device for TAVR
Feature | Heart Valve Technology| June 09, 2017
June 5, 2017 – The U.S.
Data was positive from the Watchman Left Atrial Appendage Closure (LAAC) Device from the EWOLUTION registry
News | Atrial Fibrillation| May 30, 2017
May 30, 2017 — Data was positive for safety and efficacy rates of the Watchman Left Atrial Appendage Closure (LAAC) D
Contego Medical Receives CE Mark for Vanguard IEP Peripheral Balloon Angioplasty System
News | Peripheral Artery Disease (PAD)| May 17, 2017
Contego Medical LLC announced recently that it has received CE Marking of its Vanguard IEP Peripheral Balloon...
AtriCure's AtriClip System Surpasses 100,000 Units Sold Worldwide
News | Left Atrial Appendage (LAA) Occluders| April 25, 2017
AtriCure Inc. announced it has sold more than 100,000 AtriClip Left Atrial Appendage Exclusion System devices worldwide...
PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device
News | Embolic Protection Devices| April 11, 2017
Through a new clinical trial, patients at Harrisburg, Pa.-based PinnacleHealth have access to an investigational device...
atricure atriclip, LAA occlusion, acc17

The AtriCure Atriclip surgical LAA occlusion device. It loops over the LAA on the outside of the heart and clips it off from the rest of the heart to prevent the formation of clots.

Feature | Left Atrial Appendage (LAA) Occluders| March 29, 2017
March 29, 2017 — For patients with...
Cardiogard embolic protection system for surgical valve reaplacement

The CardioGard embolic protection system for surgical aortic valve replacement.

Feature | Embolic Protection Devices| March 22, 2017
March 22, 2017 — Two U.S.
Aegis Medical Innovations, Sierra Ligation System, U.S. clinical trial, FDA approval, LAA occluder
Technology | Left Atrial Appendage (LAA) Occluders| March 22, 2017
Aegis Medical Innovations Inc. announced that it has received Investigational Device Exemption approval from the U.S....
Dee Dee Wang, Henry Ford Hospital, 3D printing for cardiology, 3-D

Dr. Dee Dee Wang with part of Henry Ford Hospital's collection of 3-D printed hearts used for education and to preplan structural heart procedures.

Feature | 3-D Printing| March 03, 2017
March 3, 2017 — A Henry Ford Hospital study found a 100 percent success rate in left atrial appendage (LAA) occlusion
Overlay Init