Boston Scientific Gets FDA OK for Carotid Artery Stent, Insurance Reimbursements on the Device Still Limited
Natick, MA-based medical devices giant Boston Scientific has garnered market approval for a carotid artery stent, the company announced yesterday afternoon. The stent is a coiled metal tube intended to prop open the carotid artery in the neck that keeps blood flowing from the heart to the brain. When plaques cause the arteries to narrow, patients are at risk of stroke and death.
Boston Scientific’s (NYSE:BSX) carotid stent, which is already marketed in Europe and other foreign markets, is intended for used in conjuction with another of the company’s devices, a filter that captures plaques dislodged from the artery during the stent-insertion procedure. The company says the procedure is less invasive than surgery to remove buildups in carotid arteries.
The FDA has previously approved carotid stents for at least one other firm, Abbott Laboratories (NYSE:ABT), the Illinois-based medical products powerhouse. Still, insurance coverage for use of carotid stents is limited to patients for which the traditional surgical option would be risky, and in April researchers reported in the New England Journal of Medicine that a study of treating carotid artery disease with stents versus surgery saw no difference between the two.
News of Boston Scientific’s stent approval follows company CEO Jim Tobin’s announcement this week that the FDA had lifted part of a moratorium on new product approvals placed on the firm in January 2006 due to quality-control issues throughout the company, according to media reports.