WASHINGTON (AP) - Doctors may soon get a new way to clear blocked neck arteries: a stent that comes with a tiny filter to catch clots stirred up by the procedure before they float to the brain.
At issue is a way to prevent pending strokes by treating blockages in the carotid artery, the main blood vessel leading to the brain.
Currently, the main method is an operation called a carotid endarterectomy, where surgeons cut into the artery and remove clogs. It requires general anesthesia, making it too risky for some people - and sometimes the operation itself triggers strokes by loosening particles that lodge in the brain. Up to 200,000 Americans a year undergo this procedure.
A less invasive alternative is called angioplasty - sending a tiny balloon into the artery to push clogs out of the way, and then propping the artery open with a scaffolding-like device called a stent.
Stents are very common in heart surgery, and some doctors use them in the neck arteries, too, even though the stroke-prevention use hasn't formally won Food and Drug Administration approval. Recent studies suggest the two procedures are roughly equal in effectiveness.
The new twist: Cordis Corp. developed a tiny filter to go with its stent and catch any stirred-up debris - in hopes of lowering the risk of an angioplasty-triggered stroke. Doctors would put the net-like filter in first, do the angioplasty, insert the stent, and then drag out the filter.
Cordis cited a study that found 12 percent of patients getting the filtered-stent procedure had suffered a stroke, heart attack or died a year after the procedure - compared with 19 percent of patients who underwent the standard carotid surgery.
Wednesday, the FDA's scientific advisers cautiously recommended approval of Cordis' Precise stent-plus-Angioguard system. But they stressed that it should be used only in high-risk patients, and that the stent should be used with the filter.
The FDA isn't bound by its advisers' recommendations but usually follows them.
