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Heart-valve rings slip through FDA loophole

Chicago Tribune, May 23, 2011

If you have a faulty heart valve and decide to get it replaced, a surgeon will implant an artificial one that has undergone rigorous examination by the Food and Drug Administration. But if you choose the option recommended for most patients -- repairing your valve with an annuloplasty ring -- there are no such guarantees, even though both devices are permanently stitched into the heart and considered life-sustaining. That's because, a decade ago, the FDA downgraded the regulatory class of the rings. Instead of being grouped with heart valves and implantable pacemakers, annuloplasty rings were put into a class with most catheters, sutures and hearing aids, which allows the medical device industry to gain approval for new rings without clinical studies. "It's absolutely ridiculous. How could something that is permanently implanted in the heart be regulated this way?" said Diana Zuckerman, president of the National Research Center for Women & Families.