Devices Neurology Cardiology

 News Release - May 3, 2006

Minnesota Company Announces Enrollment of First Patients in European Migraine Study

Clinical Trial to Study the Link Between Common Heart Defect and Migraine Headaches

MINNEAPOLIS, May 3 (HSMN NewsFeed) -- AGA Medical Corporation today announced that it has enrolled the first patients in its PRIMA 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 patients were enrolled at the Swiss Cardiovascular Center Bern, University Hospital, Bern, Switzerland.

The PRIMA (Patent foramen ovale closure Reduction In Migraine with Aura) trial is a prospective, randomized, two-arm, multi-center trial to determine whether patients who undergo closure of a PFO with the AMPLATZER PFO Occluder device have a reduction in both the number and severity of certain types of migraine headaches. The study is expected to enroll approximately 120 patients at up to 10 medical centers in Europe.

Patent foramen ovale (pronounced "pay-tent for-ay-men oh-volley") or PFO is a heart defect found in more than 20 percent of adults. A patent foramen ovale 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 small blood clots or chemicals in this unfiltered, non-regenerated blood traveling directly to the brain may trigger migraine attacks.

"We are pleased and excited to enroll the first patient in this important trial to determine a potential link between PFO closure and relief of migraine headaches," said Dr. Bernhard Meier, one of the principal cardiovascular investigators on the PRIMA Trial and Chairman and Professor of Cardiology at the Swiss Cardiovascular Center Bern, University Hospital, Bern Switzerland. "The PRIMA Trial will be conducted at leading centers throughout Europe. We are delighted to initiate this important study that could yield welcome information on the treatment of this debilitating condition."

"The PRIMA Trial is the next important step in studying the potential link between migraine and PFO," said Dr Heinrich Mattle, deputy chairman of the department of neurology of the university hospital in Bern and principal neurologist investigator on PRIMA. "The PRIMA trial is designed differently than the previous PFO Migraine trials in that the endpoint is a more appropriate 50% reduction of migraines in 50% of the patients. Additionally, the roll in phase is longer, the follow up treatment phase is longer, and neurologists are important investigators in the trial."

About 11 percent of the population suffers from 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 a PFO.

Trial neurology and cardiology specialists will select migraine patients with aura, a headache with pain that is accompanied by flashing lights, vision loss, and other temporary neurological deficits. They will provide randomized treatment of either PFO closure with the AMPLATZER PFO Occluder, or medical treatment. This randomized trial is designed for comparative evaluation of the effectiveness of PFO closure in migraine reduction.

The AMPLATZER® 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 is back to a completely normal lifestyle in less than 24 hours.

PRIMA is one of two AGA Medical sponsored studies exploring the link between PFO holes and certain types of Migraine headaches. The other study is taking place in the United States.

"We remain committed to investing actively in both PRIMA and PREMIUM studies with the objective of expanding our worldwide leadership position in transcatheter closure of structural heart defects," said Franck Gougeon, CEO of AGA Medical. "AGA is pleased to have many of the leading experts in both Europe and the U.S. participate in our migraine trials."

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 175,000 devices shipped to date. For more information visit www.amplatzer.com.

Source: AGA Medical

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