MINNEAPOLIS, Feb. 8 /PRNewswire/ -- AGA Medical Corporation announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate a new study examining the possible connections between migraine headaches and a heart defect found in more than 20 percent of all adults. A similar study in Europe is pending approval to initiate enrollment at seven medical centers throughout Europe.
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 30 medical centers. Enrollment in the study is expected to begin shortly.
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 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 very small blood clots or chemicals in this unfiltered, nonregenerated 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.
“The PREMIUM Trial is important to help determine the relationship between PFO and migraine. If the results of the trial are positive, PFO closure may provide another important treatment option for this debilitating condition” stated Dr. Stephen Silberstein, Principal Neurology Investigator on the PREMIUM Trial, American Headache Society President, and Director of the Jefferson Headache Center, Philadelphia, PA.
“PFO closure is also currently being evaluated for its effect in reducing recurrent cryptogenic stroke in a separate trial here in the U.S.,” said Dr. Jonathon Tobis, Principal Cardiology Investigator for the PREMIUM Trial, and Director of Interventional Cardiology Research at the David Geffen School of Medicine at UCLA, Los Angeles, CA, “The PREMIUM Trial is designed to evaluate another exciting potential benefit from PFO closure.”
The PREMIUM study is designed as a double-blinded evaluation of the safety of the AMPLAZTER(R) PFO Occluder, and effectiveness of PFO closure for migraine reduction in this patient population. Trial neurology and cardiology specialists will select appropriate migraine patients, and have their treatment randomly assigned to either PFO closure with the AMPLATZER(R) PFO Occluder or standard of care medical management. The study neurologists will be blinded to the treatment received by the study participants, and will follow all patients in the 12-month treatment phase.
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 one hour with the patient able to return home within 24 hours.
“AGA Medical has revolutionized the treatment of structural heart defects using minimally invasive, interventional techniques,” said Franck Gougeon, the company’s President and CEO. “We are the acknowledged leader in the field with over 150,000 devices shipped to date to close holes in the heart. A successful outcome in the PREMIUM study will enable AGA Medical to make a meaningful and lasting contribution to the treatment of migraine headaches. These headaches have a devastating impact on migraine sufferers.”
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 150,000 devices shipped to date. For more information, visit www.amplatzer.com.
MEDIA CONTACT: Elie Jacobs Brunswick Group LLC 212.333-3810 ejacobs@brunswickgroup.com Journalists can visit www.agamedicalpress.com for additional information.
AGA Medical Corporation
CONTACT: Elie Jacobs, Brunswick Group LLC, +1-212-333-3810,ejacobs@brunswickgroup.com
Web site: http://www.agamedicalpress.com/
