Abbott Laboratories (NYSE:ABT) won a favorable vote from a Food & Drug Administration advisory panel for expanded use of its RX Acculink carotid stent system.
By a vote of 7-3, with one abstention, the FDA’s Circulatory System Devices Panel today recommended that the benefits of using the company’s carotid artery stent in standard-risk patients outweighs the risks of surgically treating the patients to remove arterial blockages.
The panel’s vote is a milestone towards the agency expanding the indication of the RX Acculink.
“If the FDA approves an expanded indication, carotid artery stenting would represent an important additional option for physicians as they work with their patients to determine the best individualized treatment approach,” Abbott Vascular chief medical officer Dr. Charles Simonton said in prepared remarks.
If the agency goes along with the panel’s recommendation, Abbott still faces a major hurdle: Convincing the Centers for Medicare and Medicaid Services to approve reimbursement for standard-risk patients.
The RX Acculink is designed to relieve obstructions in the carotid artery, the main blood feed to the brain, and was was originally granted pre-market approval in August 2004 for high-risk patients. Surgeons insert the stent via catheter to prop open the blood vessel as opposed to surgically opening the artery to remove plaque obstructions in a procedure called carotid endarterectomy.
The move for an expanded indication follows the release of data from a 2,307-patient study of the device last summer. The "Carotid Revascularization Endarterectomy Versus Stenting Trial," — or "CREST" for short — compared the surgical procedure to carotid stenting with the RX Acculink device and demonstrated that stenting resulted in an adverse event rate of 7.2 percent, compared with 6.8 percent for surgery.
“[The expanded] proposed indications are supported by a primary analysis of the CREST trial data and by multiple important secondary and tertiary analyses,” according to the FDA panel’s executive summary (PDF). “The frequency of adverse events to the patients and problems with the device as reported to the sponsor is relatively low. The sponsor reports that the RX Acculink has not been withdrawn from marketing in any country for any reason.”
The nod by the FDA panel may slightly improve the mood at the Abbott Park, Ill.-based company after it today announced the lay-offs of 2 percent or its workforce, or about 1,900 employees, despite solid top-line results for both the fourth quarter and full year. The company’s stent business performed well for the year, but its pharmaceutical business significantly dragged down profits.
The FDA’s panel voted three times today to consider not only risk versus benefit, but also safety and effectiveness within the parameters of the proposed expanded indication for the RX Acculink carotid stent system. For safety, the vote was 6-4, with one abstention, and for effectiveness, the vote was 8-2, with one abstention, both in favor.