Coherex FlatStent Cleared in EU for PFO Closure

July 8, 2009—Coherex Medical, Inc. (Salt Lake City, UT) announced that the Coherex FlatStent EF patent foramen ovale (PFO) closure system has been granted CE Mark clearance for use in Europe and other countries. The company has initiated efforts for the commercial launch of the device. This clearance follows successful PFO closure procedures during the company's COHEREX-EU clinical trial, which was conducted at sites in Germany, Switzerland, New Zealand, and Australia. Professor Horst Sievert, MD, was the COHEREX-EU study's principal investigator.

According to the company, the Coherex FlatStent EF is similar in use and function to self-expanding vascular stents. However, the device combines a planar nitinol structure with a polyurethane substrate in a fusion of PFO closure mechanisms designed with the intent to naturally seal PFO tunnels. The device is cleared for use to close a PFO from within the PFO tunnel, which is done by using the body's natural defenses to enclose its polyurethane foam and nitinol metal structure.

Dr. Sievert commented, "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 of the heart. 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 separating 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. Its rapid exchange system allows a physician to deliver 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. 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."