MINNEAPOLIS--(BUSINESS WIRE)--AGA Medical Holdings, Inc. (AGA Medical) (NASDAQ:AGAM - News) 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.
Contact:
Padilla Speer Beardsley Nick Banovetz, 612.455.1705 nbanovetz@psbpr.com
