Coherex Medical has announced that its Coherex FlatStent EF PFO [patent foramen ovale] closure system has garnered CE Mark clearance for use in Europe.
"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. And to be clear, this approach works," said Horst Sievert, MD, principal investigator of the COHEREX-EU.
However, he added that the risk factors with this approach include: blood clot formation; damage or erosion of the septal wall that separates the left and right atria; and the potential for interfering with the electrical signals within the heart muscle.
The Salt Lake City-based company said its Coherex FlatStent EF is an in-tunnel device with an exchange system that allows a physician to deliver the Nitinol and polyurethane structure of the FlatStent EF to the PFO, where it can be maneuvered within the PFO tunnel.