Coated Stents Should Stay on Market, U.S. Advisers Say

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Of particular concern are the number of people , about 60 percent of total patients, who receive the devices off-label. On-label use is limited to no more than two stents; off-label covers three or more.

"The label is fairly narrow, so most are getting it off-label," Schulman explained. "Most are getting multiple stents in one single procedure, and the original clinical trials didn't cover all of those uses."

One expert said he was concerned that the FDA was sidestepping the issue of off-label use.

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"This is a most compelling and overriding public health concern that the FDA has not been willing to tackle head-on," said Dr. Robert Michler, director of the heart center at Montefiore Medical Center/Albert Einstein College of Medicine in New York City. "The stents have clearly demonstrated a reduction in restenosis rates, but the question is: at what price?"

There may actually be two prices being paid, Michler added, one being the immediate risk of blood clots and the other the fact that patients are lulled into believing that their survival rates are being improved.

"There is no evidence to support that," he said. "There has never been demonstrated a survival benefit with stents when compared to the gold standard, which is bypass surgery. If stents are being applied to patients with multi-vessel disease or single vessel disease with decreased heart function, this is being done as an off-label use because there's no evidence to support that as a lifesaving therapy."

During Friday's hearing, the second in two days, the 21 panel members, who didn't take formal votes, stated their opinions and recommendations individually or reached informal agreements on positions as a group, according to Bloomberg News. The FDA usually heeds the recommendations of its outside advisers, though it isn't required to do so.

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