AGA Applauds New Law Promoting Pediatric Medical Devices
MINNEAPOLIS, September 27, 2007 - AGA Medical Corporation ("AGA") applauded President Bush's signing of legislation to promote the development and use of pediatric medical devices. The Food and Drug Administration Amendments Act of 2007 reforms guidelines for pediatric clinical trials, makes pediatric device issues a priority at the FDA and the National Institutes of Health and provides incentives for manufacturers to bring pediatric devices to market.
"AGA is very pleased that Congress and the President have recognized the importance of creating incentives for developing devices specifically designed to treat children. Too often, doctors are forced to adapt adult devices for pediatric problems," said Franck Gougeon, President and CEO of AGA. "From the very beginning, AGA has been a pioneer in developing pediatric treatment options, and we remain committed to researching and manufacturing heart and vascular devices that will greatly improve the quality of life for children."
One in 120 children is born with a heart defect, which can severely limit their growth, activity and lifespan. AGA has revolutionized the treatment of congenital heart disease. Over the past decade, the Company's devices have transformed the standard of care for the treatment of holes in the heart, such as ventricular septal defects and atrial septal defects, from open heart surgery to minimally invasive, catheter-based technology. A procedure that was once life threatening and required lengthy recovery can now take less than an hour to perform.
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ABOUT AGA MEDICAL: AGA Medical Corporation, based in Plymouth, 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. The company is expanding into new areas such as the minimally invasive repair of vascular abnormalities. Over 700 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 250,000 devices shipped to date. For more information visit www.amplatzer.com.
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MEDIA CONTACT:
Jake Sargent
Brunswick Group LLC
202.393.7337
jsargent@brunswickgroup.com