NATIONAL HEADACHE FOUNDATION (NHF) ISSUES CAUTIONARY STATEMENT IN RESPONSE TO RECENTLY DISCLOSED DATA REGARDING PFOs and MIGRAINE
Chicago, IL – October 14, 2008 – In response to the October 13, 2008 press release issued by Coherex Medical entitled, Chronic Migraines Caused by a Hole in the Heart? "Highly Likely," New Research Says, reporting research conducted by Dr. Stephen Silberstein, the National Headache Foundation (NHF) has issued the following statement.
There has been substantial research on patent foramen ovales (PFOs) and their closure as a treatment for migraine. Current medical literature appears to question and raise serious doubt that PFOs cause migraine and that closure procedures provide relief from migraine.
Because of the publicity given by the recent press release from Coherex Medical, a company that promotes the Coherex FlatStent PFO Closure System, many physicians may perform this procedure and patients will be encouraged to have this procedure which is currently not approved by the FDA and poses significant risks.
Because of Dr. Silberstein’s presentation at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C., there is concern that some of the physicians in attendance may recommend a PFO closure before investigating other less invasive treatment options and without further studies. It should be noted that with chronic migraine it is very difficult to judge the efficacy of treatments such as the PFO closure.
Dr. Silberstein's research was sponsored in part via a grant from Coherex Medical. Further, this study was performed at an individual clinic and was not a multi-clinic study.
ABOUT THE NATIONAL HEADACHE FOUNDATION
The National Headache Foundation, founded in 1970, is a non-profit organization which exists to enhance the healthcare of headache sufferers. It is a source of help to sufferers’ families, physicians who treat headache sufferers, allied healthcare professionals and to the public. The NHF accomplishes its mission by providing educational and informational resources, supporting headache research and advocating for the understanding of headache as a legitimate neurobiological disease. Interviews with headache specialists are available upon request.
For more information on headache causes and treatments, visit www.headaches.org or call 1-888-NHF-5552 (M-F. 9 a.m. to 5 p.m. CT).
Suzanne E. Simons