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CE Mark Clearance for Coherex Medical, Inc.'s Coherex FlatStent EF PFO Closure System Entirely Anticipated Based on Its Performance in Clinical Trial, MDs Say


7/8/2009 6:35:05 AM

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SALT LAKE CITY--(BUSINESS WIRE)--After using a new medical device on opposite sides of the globe to close a heart defect found in roughly 20 percent of the population, two well-respected cardiologists claim they are not surprised that the Coherex FlatStent™ EF PFO Closure System has garnered CE Mark clearance for use in closing PFOs in Europe and other countries around the world.

According to Professor Horst Sievert, M.D., Principal Investigator of the COHEREX-EU clinical study using the Coherex FlatStent EF PFO Closure System, the Coherex FlatStent EF is unique among PFO closure technologies in the way it is used to repair patent foramen ovale – a common heart defect that experts project exists in approximately 20 percent of the worldwide population.

“The most common approach taken today for repairing a PFO is to use a device that clamps two metal mesh-like disks on either side of the PFO opening, with these disks exposed inside the left and right atria (or upper chambers) of the heart,” Dr. Sievert said. “And to be clear, this approach works. However, anytime you insert any foreign object into the heart, there are several risks, including:

* blood clot formation, * damage or erosion of the septal wall that separates the left and right atria, and even * the potential for interfering with the electrical signals within the heart muscle itself.

“These risks appear to be reduced with the Coherex FlatStent EF device, however. In fact, the Coherex FlatStent EF is the first in-tunnel device to receive regulatory clearance for PFO closure. Its rapid exchange system allows a physician to deliver the Nitinol™ and polyurethane structure of the FlatStent EF quickly and easily to the PFO where it can easily be maneuvered within the PFO tunnel before its anchors secure it into place — and that’s the key. As a result, there is very little exposed surface area within the left atrium, little or no damage to the septal wall, and significantly less metal mass than current devices. The rapid exchange design also reduces the risk of introducing an air embolism into the left atrium by eliminating the need for a large bore delivery catheter common to other devices.”

The COHEREX-EU Study – a clinical trial conducted by Coherex Medical, Inc. to pursue CE Mark clearance for the Coherex FlatStent EF device – was conducted at sites in Germany, Switzerland, New Zealand and Australia. 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.

Another physician who participated in the COHEREX-EU Study was Peter Ruygrok, M.D., Clinical Director of the Green Lane Cardiovascular Service at Auckland City Hospital in Auckland, New Zealand. Dr. Ruygrok is also on staff at the Auckland Heart Group, the largest private cardiology practice in New Zealand.

“I was delighted with the high rate of closure immediately after implantation, something I was not expecting, but I suspect we saw such results because the Coherex FlatStent EF functions almost entirely within the PFO tunnel,” Dr. Ruygrok said. “Six months after implantation, it was clear the Coherex device functioned exactly as we had anticipated – the PFO tunnels were closed, there was no more shunting of blood from the right to left atrium, and no damage to the septal wall. The final results were very encouraging and that’s what I was hoping for from an in-tunnel device like the Coherex FlatStent EF.”

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, Dr. Ruygrok explained. 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 defect is called a patent foramen ovale (PFO) – a common heart condition that occurs in approximately 20 percent of the population.

According to Coherex Medical™ President and CEO, Richard J. Linder, 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.

“The Coherex FlatStent EF is designed to repair the common heart condition called PFO and 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,” Linder said. “Receiving CE Mark clearance for the Coherex FlatStent EF PFO Closure System is clearly a significant event for our company. We also believe, however, that this is potentially a major benefit for those who suffer with this heart defect and the various clinical problems associated with PFO, as ours is the first ever in-tunnel device to receive a CE Mark. Clearly, cardiologists and patients alike now have a favorable new choice when it comes to PFO closure.”

Coherex Medical has already begun its initial efforts to ramp-up sales and marketing in Europe for its Coherex FlatStent EF, and the company expects to make future announcements about its progress as it moves forward in these areas. [NOTE: Coherex Medical also distributed another news release today that provides additional background about the CE Mark clearance granted to the Coherex FlatStent EF.]

About the Coherex FlatStent EF PFO Closure System

The Coherex FlatStent EF PFO Closure System is similar in use and function to self-expanding vascular stents that are widely used by interventional cardiologists. However, the patent-pending Coherex FlatStent EF PFO Closure System incorporates a unique fusion of PFO closure mechanisms in a design that is intended to naturally seal a PFO tunnel.

About Coherex Medical

Formed in 2003, 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 Medical and Coherex FlatStent are trademarks of Coherex Medical, Inc. All other trademarks are the properties of their respective owners.

Contact:

Coherex Medical Trent Loveless, 801-433-9900 tloveless@coherex.com or Politis Communications David Politis, 801-523-3730(w) 801-556-8184(c) dpolitis@politis.com


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