Carotid Stent Use Expanded For More Patients With Clogged Carotid Arteries

The RX Acculink carotid stent has now been approved for both high risk and standard surgical risk patients by the FDA. It was used only for patients with clogged neck arteries who could not undergo surgery because of a high risk of complications; it is now approved for all patients with blocked arteries who have a high stroke risk, regardless of surgery suitability.

The carotid arteries lie in the front of the neck. Blood flows through them to the brain. There is one carotid artery on each side of the neck. They provide the head and neck with their main blood supply.

Blood flow within a carotid artery can become undermined because of plaque, fatty material which partially or totally block its flow. A shortage of blood flow to the brain can lead to a stroke.

A stent is a small metal coil with a metal mesh that is placed in the artery to keep it open. Usually, before implanting a stent, the blockage is flattened with angioplasty.

Christy Foreman, M.B.E., director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said:

“Expanded access to RX Acculink means patients and their health care providers have another option for treating clogged neck arteries.”

The Food and Drug Administration (FDA) examined the results of a 10-year study involving 2,502 patients in 119 hospitals throughout the USA and Canada – the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) study. All patients were treated and then followed up for at least twelve months.

The study, which was partly financed by the NIH (National Institutes of Health), found that the combined risk of myocardial infarction (heart attack), stroke and death was similar for patients who received the RX Acculink stent and those who had surgery.

L. N. Hopkins, M.D., Professor and Chairman, Department of Neurosurgery, and Professor of Radiology, State University of New York at Buffalo, said:

“The CREST data demonstrated that carotid artery stenting is a safe, effective and minimally invasive treatment for standard-risk patients with carotid artery disease. With this broader indication, the RX ACCULINK Carotid Stent System will become an important option for physicians as they determine the most appropriate treatment approach for their patients.”

An FDA Advisory Committee told the FDA that the RX Acculink appeared to be generally safe and efficacious for all patients, not just those who could not undergo surgery. However, the Committee said further long-term follow-up data was needed, especially information regarding “..the importance of the stent’s use in conjunction with an embolic protection device to capture plaque and other debris that break away during the procedure, potentially causing a stroke.”

In order for approval to go through, Abbot Vascular, was told it had to produce a post-approval study in which patients treated with RX Acculink will have to be followed-up for at least three years. The aim here is to confirm the findings from the pre-market study.

The post-approval study will also have to report on how well patients aged at least 80 years responded to treatment, how successful it was, and whether patients who had clogged carotid artery symptoms had different outcomes compared to those with no symptoms before treatment occurred.

Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular, said:

“FDA approval of the RX ACCULINK Carotid Stent System for patients at standard risk of surgery has the potential to significantly impact the treatment of patients with carotid artery disease. More than 60 percent of U.S. patients with carotid artery disease are at standard surgical risk, many of whom require a procedure to open the narrowed arteries that lead to the brain. This expanded indication for Abbott’s RX ACCULINK provides these patients with an additional treatment option.”