Nov. 4, 2009 (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.