MINNEAPOLIS, July 20 /PRNewswire/ -- AGA Medical Corporation today announced that it has enrolled the first patients in its PREMIUM clinical trial, a study examining the connections between certain types of migraine headaches and a heart defect found in more than 20 percent of all adults. The first patient was enrolled at Abbott Northwestern Hospital.
The PREMIUM (Prospective Randomized investigation to Evaluate the incidence of headache reduction in subjects with Migraine and PFO Using the AMPLATZER(R) PFO Occluder compared to Medical Management) trial is a prospective, randomized, two-arm, double blind multi-center trial in the U.S. to determine whether patients who undergo closure of a PFO with an AMPLATZER(R) device have a reduction in both the frequency and severity of migraine headaches. The study is expected to enroll approximately 400 patients at up to 35 medical centers.
Patent foramen ovale or PFO (pronounced "pay-tent for-ay-men oh-volley") is a heart defect found in more than 20 percent of adults. A PFO is a small flap-like opening between the upper chambers of the heart. This opening is normal in fetuses but usually closes shortly after birth. When it remains open, or "patent," it allows blood to bypass the filtering system of the lungs. Substances such as very small blood clots or chemicals in this unfiltered, non-regenerated blood traveling directly to the brain may trigger migraine attacks.
More than 28 million people in the United States, about 11 percent of the population, suffer migraine headaches. Recent observational studies have reported that a significant number of patients experience a reduction in the frequency and severity of migraine headaches following closure of the PFO.
"We are pleased and excited to enroll the first patient in the PREMIUM clinical trial," said Dr. Ronald Tarrel, a neurologist at the Noran Neurological Clinic in Minneapolis, MN and Co-Director of the Stroke Services Program at Abbott Northwestern Hospital. "PREMIUM has the potential to yield important new information on the link between migraine and a PFO. If successful, PFO closure could represent an important new method of relief from migraine headaches for many migraine sufferers."
The AMPLATZER(R) PFO Occluder offers a less-invasive alternative to open heart surgery for closing a PFO. The device is implanted via a catheter inserted in the patient's groin. The procedure typically takes as little as 15 minutes among experienced physicians, and the patient can resume a normal lifestyle in about 24 hours.
PREMIUM is one of two AGA Medical sponsored studies exploring the link between PFO holes and certain types of Migraine headaches. The PRIMA study is already underway at sites in Europe and Canada.
"The PRIMA and PREMIUM studies represent significant opportunities to further expand AGA Medical's well established worldwide leadership position in the transcatheter closure of structural heart defects," said Franck Gougeon, CEO of AGA Medical. "AGA is pleased to be working with leading neurologists, headache specialists and cardiologists throughout the United States, Europe and Canada. Through our active, ongoing collaboration with these leaders in their respective fields, we have designed a protocol that we believe can provide a definitive answer on the relationship between PFO closure and reduction in the frequency and severity of certain types of migraine headaches."
ABOUT AGA MEDICAL: AGA Medical Corporation, based in Golden Valley, Minnesota (just outside Minneapolis) is the leader in developing interventional devices to treat structural heart defects. As a result of the many contributions and creative genius of Dr. Kurt Amplatz, the Company has developed and commercializes a series of devices that have revolutionized the treatment of the most common congenital "holes in the heart" such as atrial septal and patent foramen ovale defects. Over 500 articles have been published in peer reviewed medical publications that support the benefits of AGA Medical devices including improved patient outcomes, reduced length of stay and accelerated recovery times for the patient. AGA Medical devices have received regulatory approval and are marketed in over 90 countries with over 190,000 devices shipped to date. For more information visit http://www.amplatzer.com
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MEDIA CONTACT: Elie Jacobs Brunswick Group LLC 212.333-3810 ejacobs@brunswickgroup.com
AGA Medical CorporationCONTACT: Elie Jacobs of Brunswick Group LLC, +1-212-333-3810,ejacobs@brunswickgroup.com
