The FDA is investigating a potential safety signal with paclitaxel-coated balloons and stents used to treat peripheral artery disease, it said Thursday in a Dear Doctor letter.
“This review will focus on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes. Additional statistical analyses will be performed to clarify the presence and magnitude of any long-term risks,” the letter said.
The agency is taking action after a meta-analysis in the Journal of the American Heart Association showed that patients getting these devices placed in femoropopliteal lesions had more deaths in 2 years compared with controls.
Within days, the BASIL-3, SWEDEPAD 1, and SWEDEPAD 2 investigators announced that they were pausing enrollment for these drug-coated balloon trials.
Until there is more information available, the FDA recommended healthcare providers continue monitoring patients that got these paclitaxel-coated devices, discuss the risks and benefits of these balloons and stents with patients considering them, and report adverse events through MedWatch.
“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,” according to the agency.
The educational non-profit group VIVA Physicians is hosting a forum in February to discuss the safety of these devices.