AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
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MINNEAPOLIS, Aug. 24 / / -- AGA Medical Corporation ("AGA") announced today that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II").
The AMPLATZER Vascular Plug II expands the AGA family of occlusion devices designed to embolize, or close blood vessel and blood vessel malformations in the peripheral vasculature. The Amplatzer Vascular Plug II is a self- expandable nitinol mesh occlusion device and is designed to be introduced in a minimally invasive fashion through a catheter. The delivery cable that comes pre-attached uses the unique AMPLATZER user interface to enable the physician to more precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released. The vascular plug II is designed with multiple lobes to facilitate rapid clotting.
"I have used the new Amplatzer Vascular Plug and I found it to be very easy to use and very effective in causing a quick and complete occlusion, said Dr. James F. Benenati, Medical Director of the Peripheral Vascular Lab at the Baptist Cardiac & Vascular Institute in Miami, Florida. "Deployment is easy, radio-opacity is excellent and occlusion is complete and rapid."
The vascular plug two comes in sizes ranging from 3 mm to 22 mm enabling treatment of a wider range of vessel sizes. Unlike competing devices, a single vascular plug II is generally required to occlude the targeted vessel making it a cost and time effective alternative.
"The new vascular plug is an important addition to our family of occlusion devices", said Franck Gougeon, President and CEO of AGA. "The vascular plug is among the fastest growing AGA products and we believe this new model can only help to further accelerate its growth. With more products under development that are specifically targeted for use by interventional specialists that treat peripheral vascular disease, the vascular plug is establishing a strong and exciting foundation for future diversification by AGA Medical."
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
Source: AGA Medical Corporation
Web site: www.amplatzer.com/
