FDA probes paclitaxel-eluting stents, balloons

The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices.

The agency is “evaluating” the new information presented by the study and recommended that healthcare providers continue closely watching patients who have been treated with the drug-eluting devices.

The FDA added that it plans to assess long-term follow-up data from studies that supported the approval of paclitaxel-coated balloons or paclitaxel-eluting stents in the U.S. Specifically, the regulatory group is slated to focus on causes of death within these studies, paclitaxel dose delivered and patient characteristics.

“There are a number of paclitaxel-coated balloons or paclitaxel-eluting stents approved or under study for peripheral vascular use in the U.S.,” the FDA wrote. “Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use.”

Following the publication of the meta-analysis, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) defended the use of their paclitaxel devices in a report from the Star Tribune.

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