FDA clears St. Jude Medical's AMPLATZER Vascular Plug 4 for transcatheter embolization

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance and will immediately launch the AMPLATZER^™ Vascular Plug 4 (AVP 4) 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.

“The AMPLATZER Vascular Plugs have been beneficial in precisely targeting specific vessels for embolization”

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 Dr. Jafar Golzarian of the University of Minnesota Medical Center in Minneapolis. "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."

Vascular plugs assist physicians in quickly blocking or rerouting blood flow by occluding (closing) abnormal blood vessels. Vascular occlusion lessens pressure on malformed, weakened or leaking blood vessels and reduces blood supply to benign or malignant 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.

"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 U.S. market a more complete family of vascular plugs for peripheral embolization."

The AMPLATZER Vascular Plug 4 received European CE Mark approval in July 2009.