The FDA has expanded indications for the RX Acculink carotid stent to include patients at risk for stroke due to clogged neck arteries. This decision is a major breakthrough in the debate surrounding carotid artery stenting (CAS) and carotid endarterectomy (CEA) for stroke prevention.
The FDA approved the RX Acculink stent (Abbott Vascular) back in 2004 with indication to treat patients with clogged carotid arteries at a high risk for complication with CAE. The current approval extends usage to patients at a standard risk risk surgery, according to the agency.
The FDA said that the approval is based off of 10-year CREST trial results that found that patients treated with the device had similar rates of death, stroke and MI as patients who underwent CEA.
On Jan. 26, the FDA’s Circulatory System Devices Advisory Panel recommended that CAS extend to patients at a standard risk of stroke when undergoing surgery in a seven to three vote. One person abstained. Along with the recommendation the agency also recommended that the company conduct long-term follow-up to gain further evidence of these results.
“Expanded access to RX Acculink means patients and their health care providers have another option for treating clogged neck arteries,” said Christy Foreman, MBE, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
The FDA said that as a condition of the approval Santa Clara, Calif.-based Abbott will be required to conduct a post-approval trial that will follow patients treated with the device for at least three years. The study will also evaluate how patients age 80 and older respond to CAS treatment and whether successful outcomes are affected by physician experience.