AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II

Minneapolis (ots/PRNewswire) -

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

MEDIA CONTACT:
Devin Nagy
Brunswick Group LLC
+1-202-393-7337
[email protected]

Web site: http://www.amplatzer.com

Rückfragehinweis:
Devin Nagy of Brunswick Group LLC for AGA Medical Corporation,
+1-202-393-7337, [email protected]

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