FDA expands use of stroke treatment device

WASHINGTON - Federal well being officials have expanded approval of an artery-opening stent from Abbott to a bigger group of sufferers at risk for stroke caused by plaque buildup within the neck arteries.

The Food and Drug Administration said Friday it permitted the Acculink stent as an alternative choice to a extra invasive surgical prodedure for sufferers at reasonable risk of issues from the surgery. Beforehand it had only been authorised for those at high risk.

The surgical procedure, referred to as endarterectomy includes cutting open the neck artery and scraping out plaque formations that may block blood flow. The stent will be implanted with solely a small incision.

The FDA initially permitted Acculink in 2004.

Stents are mesh-steel tubes used to hold open arteries where plaque is starting to form. They're threaded up into the artery with a catheter through a small incision made within the groin. The procedure is less invasive than surgical procedure, though stents carry their own risks, including blood clots and rupture of the blood vessel.

About 450,000 individuals in the U.S. have carotid artery illness, or plaque buildup within the arteries that carry blood to the mind, based on Abbott. Roughly 60% of those patients are eligible to receive the stent under the brand new FDA-authorized indication. The opposite 40% had been coated beneath the prior FDA approval.

Friday's FDA approval offers Abbott an edge over medical system opponents like Boston Scientific Corp., Medtronic Inc. and Johnson & Johnson.

The FDA expanded Acculink's approval primarily based on a ten-yr examine of 2,500 patients that found comparable rates of loss of life, stroke and heart assault between sufferers getting a stent and those having surgery. The study was co-funded by the Nationwide Institutes of Health and Abbott Laboratories.

In January and FDA panel of outside consultants voted 7-three that Acculink's advantages outweighed its risks for the brand new use. However, panelists mentioned extra info is needed concerning the security of the system after it has been implanted.

As a condition of approval, the FDA is requiring Abbott to track new patients with the stent for no less than three years. Amongst different variables, the corporate will report how sufferers 80 years and older respond to treatment.

North Chicago-primarily based Abbott reported total stent sales of over $2 billion final year. The company does not break out sales of various models.