FDA Clears St. Jude Vascular Plug

The U.S. Food and Drug Administration has (FDA) has granted 510(k) clearance to St. Jude Medical for its Amplatzer vascular plug 4 (AVP4). The device will be launched immediately for use in transcatheter embolization procedures (minimally invasive procedures that involve the selective blocking of blood vessels) within the peripheral vasculature. Approximately 50,000 peripheral embolizations are performed each year in the United States, according to St. Jude.

Patients may need peripheral embolizations for various reasons, including: arteriovenous malformations; Cerebral aneurysm; gastrointestinal bleeding; epistaxis; primary post-partum hemorrhage; surgical hemorrhage; and uterine fibroids. Vascular occlusion reduces pressure on weak or damaged blood vessels, and also serves to reroute blood flow away from tumors. The current standard of care for vascular occlusion involves placing several individually threaded coils through a catheter and packing them together to block blood flow.

St. Jude is marketing the device as the first vascular plug deliverable via a standard diagnostic catheter. The AVP4 can access smaller vessels and vessels more difficult to access, the company claims. The device also features cross-sectional vessel coverage and may be recaptured and repositioned prior to deployment, which would allow physicians to block a vessel faster and more accurately than they might with embolic coils.

“The Amplatzer vascular plugs have been beneficial in precisely targeting specific vessels for embolization,” said Jafar Golzarian, M.D., of the University of Minnesota Medical Center in Minneapolis. “With the Amplatzer vascular plugs 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.”

The AVP4 received European CE Mark approval in July 2009.

“[Clearance] 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.”

Based in St. Paul, Minn., St. Jude Medical provides medical devices and technology in the cardiac, neurological and chronic pain spaces. The company has a line of vascular plugs for peripheral embolization.