Diamond Bar,
CA (March 15, 2006) -- 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 NOGA® 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
NOGA® 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 NOGA® XP Cardiac
Navigation System. Biologics Delivery Systems Group, Cordis Corporation, will
distribute the technology.
"The integration of software and catheter design found in the NOGA® 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 NOGA® 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 NOGA® 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 NOGA® XP in the U.S. in the
second quarter of 2006. The NOGA® 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 NOGA® 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 QWIKMAP® 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 NOGA® Cardiac
Navigation System. The NOGA® XP is being used in more than 17 ongoing clinical
trials throughout the world.
About Biosense Webster, Inc.
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, Inc.'s, technology
includes the largest installed base of navigation systems worldwide in leading
hospitals and teaching institutions. With proprietary products such as the
CARTOMERGE™ Image Integration Software Module, the THERMOCOOL® Irrigated Tip
Catheter and the LASSO® 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 www.cordis.com.