FDA clears Amplatzer Vascular Plug 4


The US Food and Drug Administration (FDA) has given clearance to St Jude Medical to market the Amplatzer Vascular Plug 4 (AVP 4) for use in transcatheter embolization procedures within the peripheral vasculature.

As the industry’s first vascular plug that can be delivered using a standard diagnostic catheter, the AVP 4 offers physicians the ability to treat smaller and more difficult-to-access blood vessels using vascular plug technology. The AVP 4 also provides full cross-sectional vessel coverage and may be recaptured and repositioned prior to deployment, allowing physicians to block a vessel with greater precision and speed than is achievable with conventional embolic coils.

“The Amplatzer Vascular Plugs have been beneficial in precisely targeting specific vessels for embolization,” said Jafar Golzarian, University of Minnesota Medical Center, Minneapolis, USA. “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.”

“Approval of the AVP 4 represents a significant milestone for our U.S. vascular business,” said Frank J Callaghan, president of the St Jude Medical Cardiovascular Division. “This technology simplifies the peripheral embolization procedure for physicians by eliminating the need for catheter exchanges and blocking or redirecting blood flow through the peripheral vessels in a more efficient manner than with surgical clips or embolic coils. We are excited to offer the US market a more complete family of vascular plugs for peripheral embolization.”

The Amplatzer Vascular Plug 4 received European CE mark approval in July 2009.