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AGA Medical wins new Chinese product approvals

Posted on: Mon, 09 Nov 2009 11:31:00 EST

Symbols: ABT, AGAM

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Nov 09, 2009 (Datamonitor via COMTEX) --
AGAM | Quote | Chart | News | PowerRating -- AGA Medical Holdings 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.

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. 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, said AGA Medical. The Amplatzer vascular plug II has a unique multi-segmented, multi-layered design which significantly reduces occlusion time for transcatheter embolization procedures, added AGA Medical.

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

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