Healthcare Industry News:  Atrial Septal Defect 

Devices Interventional Regulatory

 News Release - July 15, 2009

AGA Medical Corporation Receives European CE Mark Approval for AMPLATZER(R) Vascular Plug 4

Device Allows Delivery through Diagnostic Catheters

MINNEAPOLIS--(HSMN NewsFeed)--AGA Medical Corporation has received European CE Mark approval for its AMPLATZER(R) vascular plug, AVP 4. The device, which is indicated for arterial and venous embolizations in the peripheral vasculature, uses AMPLATZER’s proven mesh-braided Nitinol technology and may eliminate the need for catheter exchange, giving physicians a more efficient procedure. AGA Medical will begin marketing the AVP 4 in Europe immediately.

“The AVP 4 is a major technological advancement in the AMPLATZER vascular plug family and receiving CE Mark approval validates this achievement,” said John Barr, president and chief executive officer, AGA Medical Corporation.

With its low profile, the AVP 4 allows delivery through a standard 0.038 diagnostic catheter. The physician can now choose to use one AVP 4 instead of what often becomes multiple coil implants – without factoring in the need for a catheter exchange.

“Our physician customers requested a lower-profile option and we delivered, exceeding their expectations with the AVP 4,” Barr explained. “The AVP 4 complements our other vascular plugs, providing physicians with advanced tools to treat vascular conditions, which have the potential to reduce procedure times while offering improved flexibility and cost effectiveness.”

The AVP 4 is a single-device solution for peripheral embolization, the practice of reducing or eliminating blood flow to an area of the body by blocking – or occluding – a blood vessel to treat a wide range of circulatory and internal organ diseases. The lower-profile AVP 4 extends the reach of the AMPLATZER vascular plug family to smaller and often more distal vasculature. The device’s multi-layered, double-lobed design provides rapid embolization. Additionally, the flexible mesh and floppy distal section of the delivery wire facilitates easy tracking through torturous anatomy.

About the AMPLATZER Vascular Plug Family

AMPLATZER(R) Vascular Plugs are designed to provide embolization of peripheral arteries and veins through single-device occlusion; full cross-sectional vessel coverage; and controlled, precise deployment. A single device from the AMPLATZER Vascular Plug Family can frequently occlude a vessel that would have required many coils, providing an efficient and cost-effective alternative to coils or surgery. AMPLATZER Vascular Plugs have the ability to be recaptured and repositioned, if necessary. AGA offers the AVP 4 in diameters ranging from 4mm to 8mm.

About AGA Medical Corporation

AGA Medical Corporation, based in Plymouth, Minnesota, is a leader in developing interventional devices for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease. Founded in 1995 by Dr. Kurt Amplatz, a former professor and researcher at the University of Minnesota Department of Radiology, AGA Medical develops and commercializes devices for a range of structural heart repair and circulatory conditions. Several of these devices have been major innovations in the treatment of the most common congenital "holes in the heart," such as Atrial Septal Defects and patent foramen ovales.

More than 700 articles have been published in medical literature that support the benefits of AGA Medical devices, including improved patient outcomes, reduced length of stay and accelerated recovery times for the patient. AGA Medical devices have received regulatory approval and are marketed in 101 countries. For more information, visit www.amplatzer.com.


Source: AGA Medical

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