Healthcare Industry News:  Biosense Webster 

Devices Cardiology FDA

 News Release - March 15, 2006

U.S. Food and Drug Administration Clears Innovative Cardiac Navigation Technology

NOGA(R) XP -- 3D Electromechanical Mapping and Navigation System - Offers Physicians Next Generation Technology

DIAMOND BAR, Calif., March 15 (HSMN NewsFeed) -- The U.S. Food and Drug Administration (FDA) has cleared for marketing an innovative 3D imaging system and the only such guided electromechanical cardiac navigation technology available to physicians for use in a wide variety of advanced medical procedures.

Biologics Delivery Systems Group, Cordis Corporation, will launch the NOGAŽ XP Cardiac Navigation System, the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. The NOGAŽ XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.

Biosense Webster, Inc. developed and manufactured the NOGAŽ XP Cardiac Navigation System. Biologics Delivery Systems Group, Cordis Corporation, will distribute the technology.

"The integration of software and catheter design found in the NOGAŽ XP represents a breakthrough in cardiology which will benefit physicians and patients," said Emerson Perin, M.D., Director, New Cardiovascular Interventional Technology, Texas Heart Institute at St. Luke's Episcopal Hospital in Houston.

"Biologics Delivery Systems has established itself at the forefront of research in this area, developing technology that will enable targeted delivery of potential treatments for a wide variety of diseases such as congestive heart failure, one of the most common and most difficult coronary conditions to treat that impacts more than 20 million patients worldwide," Dr. Perin continued.

Built on a proprietary magnetic reference system that operates like a global positioning system, the NOGAŽ XP enables physicians to view the treatment area in a 3D reconstruction that represents real anatomy and provides accuracy of the site being mapped within 1 mm. These highly precise images assess heart tissue with pinpoint specificity, identifying areas for therapeutic targeting.

"The NOGAŽ XP System provides accuracy in electromechanical mapping of tissue type which enables physicians to identify a specific area for targeted therapy, " said Bill Pinon, Vice President, Biologics Delivery Systems Group.

Biologics Delivery Systems Group will launch the NOGAŽ XP in the U.S. in the second quarter of 2006. The NOGAŽ XP System has been available in Europe since late 2005 and has been well received by physicians.

"Our hospital performed a number of cases using the NOGAŽ XP," said Jens Kastrup M.D., DMSc, Director of Angiogenesis Research Program, The Heart Centre, University Hospital Rigshospitalet, Copenhagen, Denmark. "It is a truly innovative technology that offers remarkably consistent and precise tissue characterization available, which has had a significant importance for our intramyocardial delivery of stem cells and genes in cardiac patients. Features such as reduced mapping time made possible by QWIKMAPŽ Software and universal data portability that enable one to download the cardiac maps are vast improvements over existing technologies."

About Biologics Delivery Systems Group

Biologics Delivery Systems Group, Cordis Corporation, is a leader in the emerging field of biologics delivery, developing breakthrough technology in targeted delivery across multiple disease states and clinical specialties. Biologics Delivery Systems Group delivery technology is advancing the standard of care by enabling physicians to identify and visualize optimal delivery sites, and to precisely target single and multiple treatment sites. Biologics Delivery Systems Group currently markets the first generation NOGAŽ Cardiac Navigation System. The NOGAŽ XP is being used in more than 17 ongoing clinical trials throughout the world.

About Biosense Webster

Biosense Webster, Inc, a Johnson & Johnson company, pioneered EP diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic, and mapping tools. As the leader in navigation systems, Biosense Webster's technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. With proprietary products such as the CartoMerge(TM) Image Integration Software Module, the ThermoCoolŽ Irrigated Tip Catheter and the LassoŽ Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at

Source: Cordis

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