FDA Panel Backs Stents
Updated from 4 p.m.
A Food and Drug Administration panel said Thursday that while drug-coated stents seem to carry a small risk blood clots, the risk doesn't translate into a higher rate of heart attacks and deaths.
Specialists on the panel met Thursday and will reconvene Friday to review safety data, conduct public hearings and determine whether the stent makers will be required to submit additional safety data on their devices.Some stents, which are used to prop open arteries cleared of plaque, are coated with drugs designed to prevent regrowth of tissue in the area where the device is implanted. But recent studies have found that the polymers that enable the slow release of drugs remain after all active ingredients are absorbed. Scientists worry they could cause a reaction by the immune system, leading to tissue regrowth within the blood vessel. By the end of the first half of the panel meeting Thursday, the FDA committee members seemed to lean in favor of the drug-coated devices. The panel agreed that when device is used according to its FDA-approved use, there is no indication of an increased risk of heart attack or death, said FDA spokeswoman Heidi Valetkevitch. "We continue to have a meaningful scientific discussion of the issues and look forward to continued discussion tomorrow," she said Thursday afternoon. On Thursday, the panel heard presentations from companies and discussed use of the devices. Friday is expected to bring open hearings at which members of the public will have a chance to address the committee. At the meeting, panelists are expected to discuss whether FDA approvals or recommendations for stent use should be changed based on how severe a patient's condition is, whether the patient is diabetic or otherwise belongs to a high-risk group, according to briefing documents posted on the agency's Web site. The panel is also expected to discuss how long patients should take blood thinners like Bristol-Myers Squibb (BMY) and Sanofi-Aventis' (SNY) blockbuster drug Plavix after stents are implanted, another measure that doctors use to prevent artery re-clogging.
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