MINNEAPOLIS, March 29 /PRNewswire/ -- AGA Medical Corporation announced today that it has received approval from the Cantonal Ethical committee in Bern, Switzerland to initiate enrollment in a new study examining the connections between migraine headaches and a heart defect found in more than 20 percent of all adults. The company also recently announced approval from the U.S. Food and Drug Administration for a similar trial in the U.S.
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 an AMPLATZER device have a reduction in both the number and severity of migraine headaches. The study is expected to enroll approximately 120 patients at up to 8 medical centers in Europe. In addition to the approval in Switzerland, regulatory approval and enrollment in Italy, Germany, Poland and the United Kingdom is expected shortly.
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, nonregenerated blood traveling directly to the brain may trigger migraine attacks.
“PFO closure is presently in regular use for prevention of certain types of stroke in Europe and worldwide,” said Dr. Bernhard Meier, Principal Cardiovascular Investigator on the PRIMA Trial and Chairman and Professor of Cardiology at the Swiss Cardiovascular Center, University Hospital, Bern Switzerland. “The PRIMA Trial will help to determine if this very same procedure can benefit a large population of migraine sufferers who have to live day in day out with this debilitating condition.”
“The causes of migraine are still not clearly understood. If the results of the trial are positive, PFO closure may prove to be the first treatment that eliminates the cause of one form of migraine, instead of treating only the symptoms.” stated Dr Heinrich Mattle, Co-Director of the Department of Neurology, University Hospital, Bern, Switzerland and Principal Neurology Investigator for the PRIMA Trial. “In addition to potentially resolving a major health concern in a specific group of patients, we may learn important factors in the origins of migraine that could advance treatment in other areas as well.”
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, and 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 from one hour to as little as 15 minutes among experienced physicians, and the patient is able to go home in less than 24 hours.
“Our investment in the PRIMA study further reinforces the leadership position that AGA Medical has established in PFO closure around the world,” said Franck Gougeon, the company’s President and CEO. “Our devices have been used to successfully close more structural heart defects than all of our competitors combined. Early on we recognized the importance of designing a device specific for PFO closure. Introduced in Europe in 1998, our PFO devices have a well-documented record for successful closure combined with ease of use and a strong safety profile. PRIMA represents the fourth trial, currently underway and sponsored by AGA Medical, designed to establish the link between PFO closure and prevention of recurrent stroke or the treatment 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 175,000 devices shipped to date. For more information, visit http://www.amplatzer.com.
MEDIA CONTACT: Brunswick Group London: Justine McIlroy +44 207 404 5959 jmcilroy@brunswickgroup.com Frankfurt: Fiona-Claire Nagel +49 69 24 00 55 22 fnagel@brunswickgroup.com New York: Elie Jacobs +1 212 333 3810 ejacobs@brunswickgroup.com
AGA Medical Corporation
CONTACT: London: Justine McIlroy, +44-207-404-5959,jmcilroy@brunswickgroup.com, or Frankfurt: Fiona-Claire Nagel,+49-69-24-00-55-22, fnagel@brunswickgroup.com, or New York: Elie Jacobs,+1-212-333-3810, ejacobs@brunswickgroup.com, all of Brunswick Group for AGAMedical Corporation
