(By Balaseshan) St. Jude Medical Inc. (NYSE:STJ), a global medical device company, said it has got U.S. Food and Drug Administration (FDA) clearance of the Amplatzer Vascular Plug 4 (AVP 4) for use in transcatheter embolization procedures.
The company would 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.
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. About 50,000 peripheral embolizations are performed each year in the United States.
The company said 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.
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. 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 embolization 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 embolizes a vessel that would often require many coils, which makes it an efficient and cost-effective alternative.
STJ closed Friday's regular session at $35.55. The stock has been trading between $32.13 and $49.90 for the past 52 weeks.