Salt Lake City, Utah -- A new medical device has been used on opposite sides of the globe to close a heart defect found in roughly 20 percent of the population, and two respected cardiologists are unsurprised that the Coherex FlatStent EF PFO Closure System has gained CE Mark clearance for use in closing PFOs in Europe and other countries around the world.
PFOs are patent foramen ovale - a common heart defect that experts say exists in about 20 percent of the worldwide population.
According to Professor Horst Sievert MD, principal investigator of the COHEREX-EU clinical study, using the the Coherex PFO closure system is unique among PFO closure technologies in the way it is used to repair this heart defect.
"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," Sievert said. "This approach works," Sievert said. But, he added, "anytime you insert any foreign object into the heart, there are several risks."
* 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 itself.
"These risks appear to be reduced with the Coherex FlatStent EF device," Sievert said. "In fact, the Coherex FlatStent EF is the first in-tunnel device to receive regulatory clearance for PFO closure."
Physician can place the Nitinol and polyurethane structure of the FlatStent EF "quickly and easily to the PFO where it can easily be manoeuvred within the PFO tunnel before its anchors secure it into place," he said, adding "that's the key." This means 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, Sievert continued,
This rapid exchange 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, he added.
The COHEREX-EU Study was conducted at sites in Germany, Switzerland, New Zealand and Australia. Sievert is director of the CardioVascular Center Frankfurt, Sankt Katharinen.
Another physician who participated in the study was Peter Ruygrok, MD, clinical director of the Green Lane Cardiovascular Service at Auckland City Hospital in Auckland, 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," 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."
PIC: Clean room at Coherex in Salt Lake City