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Entries in Carotid Stent (1)

Friday
May062011

Cartoid Stent Approved for Wider Use

Pixland(WASHINGTON) -- Officials have approved an expanded indication that will allow a new group of patients who face the risk of stroke, to be treated with the RX Acculink carotid stent.

The U.S. Food and Drug Administration (FDA) announced the approval on Friday, allowing patients with the risk of stroke due to clogged neck arteries to have the stent implemented. This is a follow-up to the 2004 move by the FDA to allow RX Acculink for use with patients who had clogged arteries and were faced with the risk of complications if they underwent surgical treatment that involved scraping out plaque from the neck artery.

The FDA’s latest approval regarding the RX Acculink, extends the indication for use of the stent to all patients with clogged carotid arteries who face the risk of stroke.

“Expanded access to RX Acculink means patients and their health care providers have another option for treating clogged neck arteries,” said Christy Foreman, M.B.E., director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

According to a release from the FDA, with the RX Acculink, a catheter is inserted into the groin and then threaded up to the affected neck artery, following which a stent is placed into the artery to keep it open.

The FDA’s approval comes following a 10-year study that involved 2,502 patients at 119 clinical sites in the United States and Canada.

Copyright 2011 ABC News Radio







ABC News Radio