SILVER SPRING, Md., May 6, 2011 /PRNewswire-USNewswire/ — The
U.S. Food and Drug Administration today approved an expanded
indication that will allow a new group of patients at risk of
stroke due to clogged neck arteries to be treated with the RX
Acculink carotid stent.
The carotid arteries on each side of the neck bring blood to the
brain. The blood flow in the arteries can become partially or
totally blocked by fatty material called plaque. Lack of blood flow
to the brain can result in a stroke.
In 2004, the FDA approved the RX Acculink for patients with
clogged carotid arteries who were at high risk of complications if
they underwent a surgical treatment known as carotid
endarterectomy, a procedure that involves cutting open the neck
artery and scraping out the plaque.
Today’s action expands the indication for use of the stent to
include all patients with clogged carotid arteries who are at risk
for stroke, not just those who are not good candidates for
With the RX Acculink, physicians insert a catheter into the
groin and thread it up to the affected neck artery. Physicians then
place a small mesh tube, called a stent, into the artery to keep
the artery open.
“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
The FDA based its approval on a 10-year study of 2,502 patients
at 119 clinical sites in the United States and Canada. Patients
were treated and followed for at least one year. The National
Institutes of Health helped to fund the study, which found that
patients treated with RX Acculink had a similar combined rate of
death, stroke, and heart attack (myocardial inf