Originally published January 15 2006
Makers of heart device seek to market it as migraine reliever
by Mike Adams, the Health Ranger, NaturalNews Editor
California-based Cierra, which produces the PFX Closure System, used by doctors to close PFOs, or openings in the heart, are now seeking approval to market their device as a migraine reliever, after doctors discovered that patients treated with the device reported they had no more headaches.
There, the device lands on the PFO, applies suction to hold it closed, and directs radio-frequency energy at the closure site, essentially "welding" the tissue together.
The device is in the midst of clinical trials in Europe, and Cierra president and CEO Erik Engelson expects it to be approved as a PFO treatment in Europe by mid-2006.
The company also plans to launch a clinical trial of the device in migraine patients in the United States next year.
Cierra's system is the first to close PFOs without leaving behind a device implanted in heart tissue, and this was a key factor in developing a treatment specifically for the migraine condition, Engelson says.
"Implanting something permanent in these individuals didn't seem to be the appropriate level of risk, whereas leaving nothing behind seemed to be a better approach."
While rare, those risks may include blood clots or bacteria forming on the devices, according to Dr. Jonathan Tobis, director of interventional cardiology research and professor of medicine at the University of California at Los Angeles.
Cardiologists currently close PFOs with one of two implantable devices, and only perform the procedure in the case of cryptogenic stroke, which occurs when a patient has no known stroke risk factors such as heart disease.
Many of these patients also suffer from migraines, and in a majority of cases, their headaches disappear after having the heart defect fixed, Tobis and his colleagues report.
But cardiologists still haven't found an explanation for the connection between PFO closure and migraine relief, and they point out the relation remains a correlation, and not a cause-and-effect relationship.
"It's an unproven hypothesis -- that's a leap of faith right now," says Dr. Carey Kimmelstiel, associate professor of medicine at Tufts University and director of the Cardiac Catheterization Laboratory at Tufts-New England Medical Center.
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