Small Wonders - AGA Medical Corporation Pioneers Minimally Invasive Treatments for Congenital Cardiovascular Defects

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US Cardiology 2006;2005:2(1):1-1

The old adage 'good things come in small packagesÔÇÖ has perhaps never been more true than in the case of the AGA Medical Corporation. The Golden Valley (Minnesota) company is the worldÔÇÖs leading manufacturer of implantable occlusion devices that enable minimally invasive treatment of congenital heart defects and peripheral vascular disorders

AGA Medical products offer physicians and their patients less invasive alternatives to more conventional treatmentsÔÇöchiefly open-heart surgery. Compared with an open-heart procedure, treatment with an AGA Medical device typically reduces patient trauma, shortens hospital stay and recovery time, and lowers overall treatment costs.

Founded in 1995 by Dr Kurt Amplatz, a former University of Minnesota radiology professor and a pioneer in the field of interventional radiology, AGA Medical employs 145 people and markets its products in 92 countries.

The companyÔÇÖs patented AMPLATZER┬« Occlusion Devices have been implanted in more than 40,000 patients in 92 countries worldwide. Since December 2001, it has received full or partial approval from the US Food and Drug Administration (FDA) to market four of its products in the US. Additionally, AGA Medical is investigating the possibility of a correlation that exists between the presence of a heart defect (also referred to as Patent Foramen Ovale or PFO) and the occurrence of strokes and migraines in some patients. The company is pursuing clinical studies to investigate closure of these defects using its patented AMPLATZER┬« PFO Occluder.

Minimally Invasive Occlusion

Congenital heart defects often present as gaps, or holes, in the walls of tissue that divide the heartÔÇÖs chambers. Left untreated, they can lead to serious, even fatal, health complications. Standard forms of treatment include anticoagulant drugs or open-heart surgery. AGA MedicalÔÇÖs devices, which are implantable via a catheter, are uniquely engineered to 'occludeÔÇÖ, or close, the defects, helping patients avoid a lifetime of drug therapy or the rigors of open-heart surgery.

The company also manufactures a device that physicians can use to occlude veins and arteries outside of the heart.Vascular occlusion is often indicated to help a patient avoid a burst aneurysm, to block blood flow to a growing tumor, or to correct situations where the venous and arterial sides of the circulatory system connect abnormally.

Often no larger than the diameter of an American quarter, AMPLATZER® Devices are made from Nitinol-wire mesh and lined with polyester fabric to inhibit blood flow, thus promoting occlusion. Nitinol, a nickel and titanium alloy, has properties that allow a device to be compressed inside a delivery sheath, then spring back to full size once deployed within the heart defect or blood vessel.

ÔÇ£At AGA Medical weÔÇÖre proud to be at the forefront of medical technologies that, while highly effective in treating many common and serious heart and vascular conditions, also actually reduce the overall impact on patients and the healthcare system,ÔÇØ said CEO Franck Gougeon. Ôûá