Abbott to ask FDA panel for expanded approval of carotid stent

An FDA panel will review an Abbott Labs carotid stent Wednesday for use in less-risky patients. The Acculink carotid stent has already been approved for higher-risk patients, but Abbott wants the flexibility to market the stent for patients with fewer risks.

In a 2,502 patient Abbott-funded study whose results were released in preparation for the panel meeting, the stent procedure didn't create more risks than a carotid endarterectomy surgery, where the fatty deposits in the carotid artery are scraped out. In October, the Archives of Neurology published findings that neck stents did create a greater chance of stroke and death.

Abbott spokesman Jonathon Hamilton said if FDA approves the wider use, the company will also seek expanded reimbursement coverage through Medicare, Reuters adds.

- see the Reuters coverage
- get the panel documents here