Federal health officials have expanded approval of an artery-opening stent from Abbott to a larger group of patients at risk for stroke caused by plaque buildup in the neck arteries.
The Food and Drug Administration said Friday it approved the Acculink stent as an alternative to a more invasive surgical prodedure for patients at moderate risk of complications from the surgery. Previously it had only been approved for those at high risk.
The surgery, called endarterectomy involves cutting open the neck artery and scraping out plaque formations that can block blood flow. The stent can be implanted with only a small incision.
The FDA originally approved Acculink in 2004.
Stents are mesh-metal tubes used to hold open arteries where plaque is beginning to form. They are threaded up into the artery with a catheter through a small incision made in the groin. The procedure is less invasive than surgery, though stents carry their own risks, including blood clots and rupture of the blood vessel.
About 450,000 people in the U.S. have carotid artery disease, or plaque buildup in the arteries that carry blood to the brain, according to Abbott. Roughly 60 percent of those patients are eligible to receive the stent under the new FDA-approved indication. The other 40 percent were covered under the prior FDA approval.
Friday's FDA approval gives Abbott an edge over medical device competitors like Boston Scientific Corp., Medtronic Inc. and Johnson & Johnson.
The FDA expanded Acculink's approval based on a 10-year study of 2,500 patients that found similar rates of death, stroke and heart attack between patients getting a stent and those having surgery. The study was co-funded by the National Institutes of Health and Abbott Laboratories.
In January and FDA panel of outside experts voted 7-3 that Acculink's benefits outweighed its risks for the new use. However, panelists said more information is needed about the safety of the device after it has been implanted.
As a condition of approval, the FDA is requiring Abbott to track new patients with the stent for at least three years. Among other variables, the company will report how patients 80 years and older respond to treatment.
North Chicago-based Abbott reported total stent sales of over $2 billion last year. The company does not break out sales of various models.