Healthcare Industry News:  migraine 

Devices Interventional Cardiology

 News Release - October 2, 2007

Coherex Medical to Begin its COHEREX-EU Study to Pursue CE Mark Clearance for its Coherex FlatStent PFO Closure System

Professor Horst Sievert, M.D. Selected as Principal Investigator for the COHEREX-EU Study

SALT LAKE CITY & FRANKFURT, Germany--(HSMN NewsFeed)--Coherex Medical, Inc., a privately held medical device company, today announced it will soon begin its COHEREX-EU Study to pursue CE Mark clearance for the Coherex FlatStent(TM) PFO Closure System. Additionally, Professor Horst Sievert, M.D. (an internationally renowned interventional cardiologist) has been selected by the company as its Principal Investigator for its COHEREX-EU Study.

Coherex(TM) will soon begin enrolling patients for its COHEREX-EU Study and anticipates completing the first human implants of its Coherex FlatStent PFO Closure System in the near future.

"We are extremely pleased to have received all of the clearances and approvals necessary from the governing regulatory agencies and committees to begin our COHEREX-EU Study," said Richard J. Linder, president and CEO of Coherex Medical. "In addition, we are quite honored to have Professor Sievert lead this study as our Principal Investigator and look forward to tracking his progress as we pursue CE Mark clearance for the Coherex FlatStent PFO Closure System."

"Coherex has developed a unique approach to treating the common heart defect we know as PFO (Patent Foramen Ovale)," Prof. Sievert said. "The Coherex FlatStent has potential significant benefits over existing PFO closure technologies because it promises to be safer, easier to use and may improve closure rates. Given that approximately 25 percent of adults have a PFO, there is a significant need for the Coherex FlatStent. I look forward to evaluating this novel new technology in the coming days."

Professor Horst Sievert, M.D. Background Information

Dr. Sievert is the Director of the CardioVascular Center Frankfurt, Sankt Katharinen, and the Department of Internal Medicine, Cardiology and Vascular Medicine of the Sankt Katharinen Hospital in Frankfurt, Germany. He is also an Associate Professor of Internal Medicine/Cardiology at the University of Frankfurt.

Dr. Sievert received his medical degree at the University of Frankfurt, Germany. After training in internal medicine, nephrology and intensive care medicine, he completed a fellowship in cardiology and vascular medicine under the direction of Dr. Martin Kaltenbach. Dr. Sievert became director of the Department of Interventional Cardiology and Angiology of the Heart Center Rotenburg in 1990, senior consultant at the Bethanien Hospital in Frankfurt in 1993 and director of the CardioVascular Center Frankfurt, Sankt Katharinen in 2003. Additionally, earlier this year Dr. Sievert was appointed Director of Structural Heart Interventions and the Peripheral Cath Lab at the Washington Hospital Center in Washington, D.C.

He has been the Principal Investigator of numerous clinical trials and has authored more than 130 manuscripts and 600 abstracts in peer-reviewed journals, as well as 70 books and book contributions. Dr. Sievert has also delivered more than 600 invited lectures around the world.

He has personally performed more than 16,000 PCIs (percutaneous coronary interventions) and 6,000 peripheral angioplasties. However, his activity in the cath lab is focused on highly specialized non-coronary interventions for patients with congenital heart disease, carotid disease or a high risk of stroke, among other conditions. Dr. Sievert was the first physician to close a left atrial appendage percutaneously. He has the most experience in the world in catheter closure of heart defects in adults and regularly receives referrals from around the world.

About Patent Foramen Ovale (PFO) Heart Defects

A foramen ovale is a tunnel-like opening between the upper chambers of the heart that is present in all fetuses and allows blood to bypass the lungs. Normally, the foramen ovale closes soon after an infant is born. However, if this opening fails to close naturally after birth the opening is said to remain patent and the condition is called a patent foramen ovale (PFO).

A common heart defect that occurs in roughly 25 percent of the population, PFOs allow blood to bypass the lungs and shunt directly from the right side of the heart to the left, thus
  • increasing the likelihood of blood clots in the heart flowing directly to the brain; and
  • preventing the filtration of chemicals out of the blood that occurs in the lungs.
At least two medical conditions that may benefit from PFO closure: stroke and migraine. According to the Stroke Council of the American Heart Association, approximately 500,000 strokes each year worldwide may be attributable to the presence of a PFO, which represents a potential annual market size of close to $2 billion.

migraine affects approximately 12 percent of adults. Multiple retrospective studies have demonstrated a marked reduction in migraine symptoms following PFO closure. As such, the worldwide market potential for PFO closure to treat migraine patients has been estimated to be more than $15 billion per year.

About the Coherex FlatStent PFO Closure System

The Coherex FlatStent PFO Closure System is similar in use and function to self-expanding vascular stents which are widely used by Interventional Cardiologists. However, Coherex' patent-pending FlatStent Closure System incorporates a unique fusion of PFO closure mechanisms and accepted medical practices in a design expected to naturally seal a PFO tunnel.

About Coherex Medical

Formed in 2003 by Brian Whisenant, M.D., Coherex Medical is focused on addressing structural heart disease and conditions through medical devices. For more information, please visit www.coherex.com or call 801-433-9900.

Coherex and FlatStent are trademarks of Coherex Medical, Inc. All other trademarks are the properties of their respective owners.


Source: Coherex Medical

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