FDA

FDA Investigating Long-Term Mortality Related to Paclitaxel-Coated Balloons and Stents

By MedTech Intelligence Staff
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FDA

The agency issued a letter to healthcare providers following a journal study about the potential risk of these devices in patients with a type of peripheral arterial disease.

Following the publication of a paper in the Journal of the American Heart Association that discusses the potential risk of death in certain peripheral arterial disease (PAD) patients who received paclitaxel-coated vascular balloons or drug-eluting stents, FDA is on the alert. On January 17 the agency issued a letter to healthcare providers about the issue, recommending that doctors continue to monitor patients treated with the device. However, at this point the agency believes that the benefits of these balloons and stents still outweigh the risks.

The journal paper specifically looked at patients with PAD who were treated with paclitaxel-coated vascular balloons or paclitaxel-eluting stents that release the drug in the femoropopliteal artery (in the leg), and compared data to patients treated with non-coated balloons or bare metal stents. They found an “increased risk of death” in patients who received the devices with paclitaxel and urged that further investigation is needed. According to the FDA alert, the increased risk of death happened at two years and beyond.

FDA is looking at long-term follow-up data to assess whether there are risks related to paclitaxel-coated devices, and if so, to what extent they exist.

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