The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them.
In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who have been treated with them.
The FDA left it up to clinicians to determine whether the benefits of using paclitaxel-eluting stents and balloons in patients at high risk for restenosis and repeat femoral bypass surgeries.
Use of the devices plunged after a meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons and stents could be at a higher risk for late death. An FDA panel convened to consider the evidence in June.
“Clinicians may determine that the benefits of using a paclitaxel-coated device outweigh the risk of late mortality,” the agency letter said. “For many patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents provide a more favorable benefit-risk profile based on currently available information.”
The FDA said it will continue working with manufacturers and investigators on assessing the devices’ long-term safety and with medtech companies on labeling updates to include information about the late-mortality risk.