AGA Medical Corporation Receives FDA And CE Mark Approvals For The AMPLATZER Vascular Plug II

AGA Medical Corporation ("AGA")
announced 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
amplatzer


AGA Medical Corporation

amplatzer

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