FDA Clears St. Jude Medical's Amplatzer Vascular Plug 4

June 18, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced that it has received US Food and Drug Administration clearance for the Amplatzer Vascular Plug 4 (AVP 4) for use in transcatheter embolization procedures within the peripheral vasculature. The company will immediately launch the device in the United States. The AVP 4 received European CE Mark approval in July 2009.

According to St. Jude Medical, the Amplatzer vascular plugs are designed to provide optimal embolization of peripheral arteries and veins through single-device occlusion. The AVP 4 can be delivered using a standard diagnostic catheter, and allows for the treatment of small and difficult-to-access blood vessels. The company advised that the AVP 4 also provides full cross-sectional vessel coverage and may be recaptured and repositioned prior to deployment, allowing for fast, precise blockage.

“The Amplatzer vascular plugs have been beneficial in precisely targeting specific vessels for embolization,” said Jafar Golzarian, MD, of the University of Minnesota Medical Center in Minneapolis, in a press release. “With the Amplatzer Vascular Plug 4 we now have the ability to use a diagnostic catheter to deliver the device, which means that patients in need of embolization of smaller, more tortuous vessels can benefit from this technology.”