"The results of the PREVAIL trial add to the wealth of previously published data confirming the utility of the WATCHMAN device as an option for the reduction of stroke in high risk patients," said Kenneth Stein, M.D., chief medical officer, Cardiac Rhythm Management, Boston Scientific. "WATCHMAN is the only device-based alternative to anticoagulation that has undergone rigorous scientific study. We are pleased the PREVAIL results showed low complication rates with both new and experienced operators and significantly lower complications than the early stage of the PROTECT AF trial."
Data from the PREVAIL trial, complemented by the PROTECT AF four-year outcomes data, the WATCHMAN Pilot study six-year data, the ASAP study and the CAP registry data update will be submitted to support device approval by the U.S. Food and Drug Administration (FDA).
The WATCHMAN device was approved for sale in Europe in 2005 and some countries in Asia in 2009. It is already commercially available in 40 countries worldwide. In the United States, WATCHMAN is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Atritech, which Boston Scientific acquired in March 2011. Please visit http:// www.bostonscientific.com/PREVAIL for more information. Images of the WATCHMAN device are available for download at http://bostonscientific.mediaroom.com/image-gallery?mode=gallery&cat=1760.
Atrial fibrillation (AF) affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. AF patients have a five times greater risk of stroke. Blood-thinning medications have previously been the only therapy for reducing stroke risk in these patients. Boston Scientific offers an alternative to chronic medication. The WATCHMAN device is introduced into the heart via a flexible tube (catheter) through a vein in the groin and closes off the LAA.