Healthcare Industry News:  Vascular Stent 

Devices Interventional Cardiology Regulatory

 News Release - July 8, 2009

Coherex Medical's Coherex FlatStent EF PFO Closure System Granted CE Mark Clearance for Closing PFOs - a Common Heart Defect; Company to Begin Sales/Marketing Efforts in Europe

The Coherex FlatStent is the first “in tunnel” medical device to receive regulatory clearance to close Patent Foramen Ovales (PFOs)

PFOs are common heart defects found in approximately 20 percent of the worldwide population

PFO closure is estimated to be a multi-billion dollar annual market

SALT LAKE CITY--(HSMN NewsFeed)--Coherex Medical, Inc. today announced that its Coherex FlatStent(TM) EF PFO Closure System has been granted CE Mark clearance for use in Europe and other countries to close Patent Foramen Ovales (PFO), a common heart defect found in approximately 20 percent of the worldwide population.

As a result, Coherex Medical(TM) has begun initial efforts to ramp-up sales and marketing in Europe for its Coherex FlatStent EF PFO Closure System. The company also expects to make future announcements about its progress as it moves forward in these areas.

The Coherex FlatStent EF device is similar in use and function to self-expanding Vascular Stents that are widely used around the world by interventional cardiologists. However, the patent-pending Coherex FlatStent EF device combines a planar Nitinol(TM) structure with a polyurethane substrate in a unique fusion of PFO closure mechanisms designed with the intent to naturally seal PFO tunnels.

According to Coherex President and CEO, Richard J. Linder, the Coherex FlatStent EF is the first device cleared for use to close a PFO from within the PFO tunnel.

“Although there are a handful of older, legacy devices cleared for closing PFOs, these devices are significantly larger than the Coherex FlatStent EF and they close PFOs by completely overlapping PFO openings on both sides of the septal wall,” Linder said. “Conversely, by its very design, the Coherex FlatStent EF represents the next generation approach to PFO closure. The Coherex FlatStent EF has dramatically less mass and less exposed surface area than other PFO closure systems and it is deployed almost entirely within the PFO tunnel (the only exception being two tiny anchors). As a result, the Coherex FlatStent EF uses a body’s natural defenses to enclose its polyurethane foam and Nitinol metal structure and thereby close the PFO opening from within the PFO tunnel. We believe this technology will be much safer for patients during the long term and reduce or eliminate safety concerns that are associated with older technologies.”

Coherex Medical was granted CE Mark clearance for its Coherex FlatStent EF PFO Closure System following successful PFO closure procedures during its COHEREX-EU Study – a clinical trial conducted at sites in Germany, Switzerland, New Zealand and Australia. Leading the COHEREX-EU Study as Principal Investigator was Professor Horst Sievert, M.D., an internationally renowned interventional cardiologist. [NOTE: Coherex Medical also distributed another news release today that provides additional background on Dr. Sievert and some of his opinions about the Coherex FlatStent EF.]

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 while a fetus is in the womb. 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 approximately 20 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 blood flowing through the body, this shunt may allow unfiltered blood clots and other components to travel directly to the brain or other regions of the body.

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.

In addition, 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 even larger than the stroke market once a successful randomized clinical trial is completed.

“The Coherex FlatStent EF is designed to prevent this potentially dangerous right-to-left shunting of blood directly from one side of the heart to the other without passing through the lungs by closing the PFO,” Linder said. “It is clearly a significant event for Coherex Medical to receive CE Mark clearance for the Coherex FlatStent EF PFO Closure System. However, as the first ever in-tunnel device to receive a CE Mark, we also feel that this is potentially a major benefit for those who suffer with this heart defect. European cardiologists and patients alike now have a clear choice when it comes to PFO closure: They can go with older legacy technologies or they can go with the next generation PFO closure solution – the Coherex FlatStent EF.”

About Coherex Medical

Formed in 2003, Coherex Medical is focused on addressing structural heart disease and conditions through the development of innovative medical devices. For more information, please visit or call 801-433-9900.

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

Source: Coherex Medical

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