A Medical Device Daily
AGA Medical (AGA; Minneapolis) said Friday that it has received FDA and CE mark approvals for the Amplatzer vascular plug II.
The Amplatzer is a self-expandable nitinol mesh occlusion device and is designed to be introduced in a minimally invasive fashion through a catheter. The delivery cable that comes pre-attached uses the Amplatzer user interface to enable the physician to more precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released. The vascular plug II is designed with multiple lobes to facilitate rapid clotting.
The new vascular plug comes in sizes ranging from 3mm to 22mm enabling treatment of a wider range of vessel sizes.
“The new vascular plug is an important addition to our family of occlusion devices,” said Franck Gougeon, president/CEO of AGA. “With more products under development that are specifically targeted for use by interventional specialists that treat peripheral vascular disease, the vascular plug is establishing a strong and exciting foundation for future diversification by AGA Medical.”
AGA Medical specializes in the repair of congenital and structural heart defects using non-surgical techniques for treating a wide range of these life-threatening diseases.