St.Jude’s Amplatzer™ Vascular Plug 4 Cleared By FDA For Peripheral Vessels

In short

St. Jude Medical, Inc. has received FDA clearance and will immediately launch the Amplatzer™ Vascular Plug 4 (AVP 4) for use in transcatheter embolisation procedures within the peripheral vasculature.

Background

St.Jude reckons approximately 50,000 peripheral embolisations are performed each year in the United States and with its range of different embolisation catheter configurations the company is clearly trying to meet all anatomical challenges faced with the procedure.

Vascular plugs assist physicians in quickly blocking or rerouting blood flow by occluding 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.

AVP 4 is the latest addition to the Amplatzer Family of Vascular Plugs, which includes the AVP and AVP II devices in the U.S. The Amplatzer Family of Vascular Plugs are designed to provide optimal embolisation of peripheral arteries and veins through single-device occlusion; full cross-sectional vessel coverage; and controlled, precise deployment. A single device from the Amplatzer Family of Vascular Plug embolises a vessel that would often require many coils, which makes it an efficient and cost-effective alternative.

AVP4 is the industry’s first vascular plug that can be delivered using a standard diagnostic catheter, and its floppy distal section 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.

Clinician comments

“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 embolisation of smaller, more tortuous vessels can benefit from this technology.”

Company comments

“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.”

EU regulatory status

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

Source: Adapted from a press release from St.Jude Medical Inc.. Business Wire