Carotid Stent Receives FDA Approval For Widespread Use
Patients who are at a high risk for stroke due to clogged carotid arteries may now be eligible for a less-invasive corrective procedure known as a carotid stent.
The announced on Friday that the carotid stent RX Acculink, which is the device used to unblock the carotid arteries in the neck and prevent stroke, can now be made available to all patients who are considered a high risk for stroke due to carotid artery disease. This decision will allow for more widespread use of the device which was previously only approved for patients ineligible for the standard surgical procedure used to unblock arteries.
Carotid Artery Disease
The carotid arteries are the two main blood vessels located in the neck which supply blood to the brain. Like other blood vessels in the body, they are susceptible to the buildup of a fatty substance called plaque as a result of poor diet, lack of exercise, and elevated cholesterol levels. As plaque builds up inside the carotid arteries, the vessels become more narrow and damaged which promotes the formation of blood clots at the site of injury. If these blood clots break off and become lodged in the blood vessels supplying blood to the brain – this is called a stroke.
Up until 2004, the only treatment for blocked carotid arteries was a procedure called an endarterectomy. This surgical technique is performed under general anesthesia and involves a surgeon manually scrapping out plaque from the carotid artery. However, like all surgeries, this procedure involves many risks for patients – particularly patients who may have other conditions which may make them unable to withstand a major surgical procedure.
In 2004, Abbott's RX Acculink carotid stent device was given approval as an alternative option for those who need surgical de-blocking of the carotids, but were a high surgical risk. These patients were required to be symptomatic with at least 50 percent blockage or asymptomatic with 80 percent blockage.
The advantage of the carotid stent procedure over the endarterectomy is that it does not require a major surgical intervention. The patient receives a local anesthesia at the incision site in the groin area. A special catheter is then guided by X-ray and contrast material from the femoral artery to the blockage site in the neck. Once the blocked artery has been reached a small balloon is inflated which re-opens the vessel. Then a stent is left in place to help support the artery, similar to scaffolding.
In order to evaluate the efficiency and safety of the carotid stent procedure, a 10 year study, called the CREST study, was conducted by the National Institute of Neurological Disorders and Stroke. The results, published in the New England Journal of Medicine, showed that the stent produced results equivalent to the surgery in all patients – regardless of surgical risk.
Based on these findings the FDA voted last week to approve the expansion of this device to all patients at a high risk for 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.
Further studies are continuing to be conducted on the safety and efficiency of the RX Acculink. The CHOICE study (Carotid Stenting for High Surgical-Risk Patients) is one example of an ongoing study evaluating this device for the outcome on death, stroke and myocardial infarction. Already this study has generated positive results. One participating group of cardiologists reported that out of 80 carotid stents placed, there has not been a single stroke reported. In addition, the typical side effects of carotid artery clearing surgery which include cranial nerve palsy, infection, and bleeding have been avoided in these patients.
The FDA did add one condition to its approval of Abbot's device which is a requirement of a three year post-study follow up on all study participants.