News | October 23, 2007

First "Live Case" Transmission Of PFO Closure Procedure Using The Coherex FlatStent PFO Closure System Presented

Salt Lake City, UT & Washington, DC - Physicians attending the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium had the first opportunity to observe a "live case" PFO closure procedure using the Coherex FlatStent™ PFO Closure System, announced Coherex Medical.

The live case was part of the COHEREX-EU CE Mark Study conducted on Monday, October 22, 2007 at Sankt Katharinen Hospital in Frankfurt, Germany and delivered via closed circuit satellite broadcast in the Main Arena at TCT 2007. Prof. Horst Sievert, M.D. is the Principal Investigator of the COHEREX-EU Study.

"This live case broadcast is a great opportunity for cardiologists to see how the Coherex FlatStent can be used to close a heart defect called a patent foramen ovale (PFO) quickly and easily," said Richard J. Linder, Coherex president and CEO. "Approximately 25 percent of all adults have a PFO, which may lead to an increased incidence of stroke or migraine. We believe that we have pioneered a new class of stent that will be used in much the same way as existing stents but with one major exception – the Coherex FlatStent is used to close a cardiac structure instead of opening one."

About Patent Foramen Ovale (PFO) Heart Defects
A foramen ovale is a tunnel-like opening between the upper chambers of the heart that allows blood to bypass the lungs and is present in all fetuses. 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).

PFO is a common heart defect that occurs in approximately 25 percent of the population. Under certain conditions, a PFO may allow blood to bypass the lungs and shunt directly from the right side of the heart to the left. Since the lungs normally filter all of the blood, this shunt may allow unfiltered blood clots and other components to travel directly to the brain.

There are 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.

SOURCE: Coherex Medical