AGA Medical Receives Product Approvals in China

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Wed Nov 4, 2009 8:00am EST

Company Plans to Expand in Opportune Market
MINNEAPOLIS--(Business Wire)--
AGA Medical Holdings, Inc. (AGA Medical) (NASDAQ:AGAM) has received regulatory
approvals and licenses in China for its AMPLATZER® PFO Occluder and AMPLATZER®
Multi-Fenestrated Septal Occluder "Cribriform." The company has also received
regulatory approval for its AMPLATZER® Vascular Plug II in China, and its
license is pending. The company plans to make the products available through its
distributor Abbott Vascular, a division of Abbott Laboratories, Inc. 

"We see considerable opportunities in developing markets, such as China, and we
are excited to expand our presence there," said John Barr, president and chief
executive officer of AGA Medical. "Today`s announcement demonstrates our ability
to obtain product approvals in important markets, and we look forward to making
AMPLATZER products more widely available." 

About the Products

AGA Medical designed the AMPLATZER PFO Occluder for closure of PFO, or patent
foramen ovale, defects using a minimally invasive transcatheter procedure
instead of surgery. PFO is the most common structural heart defect. The
AMPLATZER Multi-Fenestrated Septal Occluder "Cribriform" is designed for use in
multiple-hole atrial septal defects, an abnormal opening in the wall between the
left and right atria. 

The AMPLATZER Vascular Plugs are designed to provide optimal embolization of
peripheral veins and arteries through single device occlusion, full
cross-sectional vessel coverage, controlled and precise deployment. The
AMPLATZER Vascular Plug II has a unique multi-segmented, multi-layered design
which significantly reduces occlusion time for transcatheter embolization
procedures. 

About AGA Medical

AGA Medical, based in Plymouth, Minnesota, is a leading innovator and
manufacturer of medical devices for the treatment of structural heart defects
and vascular diseases. AGA Medical`s AMPLATZER occlusion devices offer minimally
invasive, transcatheter treatments that have been clinically shown to be highly
effective in defect closure. The Company`s devices and delivery systems use
relatively small catheters and can be retrieved and repositioned prior to
release from the delivery cable, enabling optimal placement without the need to
repeat the procedure or use multiple devices. AGA Medical is the only
manufacturer with occlusion devices approved to close seven different structural
heart defects, with leading market positions for each of its devices. More than
1,500 articles supporting the benefits of AMPLATZER products have been published
in medical literature. AGA Medical markets AMPLATZER products in 112 countries
worldwide. In addition to its presence with cardiologists, AGA Medical has also
leveraged its core competencies in nitinol braiding and transcatheter delivery
systems to develop products for the treatment of certain vascular diseases,
which are sold primarily to interventional radiologists and vascular surgeons. 

Forward-Looking Statements

This news release and any attachments may include "forward-looking statements,"
within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange
Act, including, in particular, earnings guidance and any statements about the
Company`s plans, strategies and prospects.These statements are based on the
beliefs of our management as well as assumptions made by, and information
currently available to, the Company. These statements reflect the Company's
current views with respect to future events, are not guarantees of future
performance and involve risks and uncertainties that could cause actual
performance or results to differ materially from those expressed in or suggested
by the forward-looking statements. These factors include, among other things:
failure to implement the Company`s business strategy; failure to capitalize on
the Company`s expected market opportunities; lack of regulatory approval and
market acceptance of the Company`s new products, product enhancements or new
applications for existing products; regulatory developments in key markets for
the Company`s AMPLATZER occlusion devices; failure to complete the Company`s
clinical trials or failure to achieve the desired results in our clinical
trials; inability to successfully commercialize the Company`s existing and
future research and development programs; failure to protect the Company`s
intellectual property; intellectual property claims exposure, related litigation
expense, and any resultant damages, awarded royalties or other remedies, in
particular resulting from our Medtronic and Occlutech litigations; competition;
decreased demand for the Company`s products; product liability claims exposure;
failure to otherwise comply with laws and regulations; changes in general
economic and business conditions; changes in currency exchange rates and
interest rates; and other risks and uncertainties, including those detailed in
the Company`s Registration Statement on Form S-1 relating to its initial public
offering, as well as from time to time in the Company`s periodic reports filed
with the Securities and Exchange Commission. You should not put undue reliance
on any forward-looking statements. You should understand that many important
factors, including those discussed herein, could cause the Company`s results to
differ materially from those expressed or suggested in any forward-looking
statement. Except as required by law, the Company does not undertake any
obligation to update or revise these forward-looking statements to reflect new
information or events or circumstances that occur after the date of this news
release or to reflect the occurrence of unanticipated events or otherwise.
Readers are advised to review the Company's filings with the Securities and
Exchange Commission (which are available from the SEC's EDGAR database at
www.sec.gov, at various SEC reference facilities in the United States and via
the Company's website at www.amplatzer.com).

For more information, visit www.amplatzer.com.

Padilla Speer Beardsley
Nick Banovetz, 612.455.1705
nbanovetz@psbpr.com

Copyright Business Wire 2009

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