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April 22, 2021  
HEART NEWS: Feature Story

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  • FDA Panel Cautiously Backs New Stent

    FDA Panel Cautiously Backs New Stent


    April 22, 2004

    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.


    Last updated: 22-Apr-04

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