St. Jude Medical received FDA clearance for its AMPLATZER Vascular Plug 4 (AVP 4), a minimally invasive device for performing transcatheter embolization procedures.
This is the first vascular plug that is positioned using a standard diagnostic catheter, permitting its use in difficult to access peripheral vasculature.
From the announcement:
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.”
Press release: St. Jude Medical Announces FDA Clearance of the AMPLATZER Vascular Plug 4…
Product page: AMPLATZER vascular plug…
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