The United States Food and Drug Administration (FDA) has issued a Letter to Health Care Providers concerning treatment of paclitaxel-coated balloons and paclitaxel-eluting stents potentially associated with increased mortality.
FDA is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease (PAD) in the femoropopliteal artery.
A recent meta-analysis of randomized trials published in the Journal of the American Heart Association (JAHA) suggests a possible increased mortality rate after two years in PAD patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with control devices (non-coated balloons or bare metal stents). The specific cause for this observation is yet to be determined.
Paclitaxel-coated balloons and paclitaxel-eluting stents are intended to treat de novo or restenotic lesions in the femoropopliteal artery. The balloon and stent work to mechanically open the obstructed vessel. Paclitaxel is released from the balloon or stent to prevent scar tissue formation in the blood vessel that can re-obstruct the artery (restenosis).
The FDA is currently evaluating available long-term follow-up data to determine if there are any long-term risks associated with paclitaxel-coated products. 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. FDA is working with manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents to better understand this issue.
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.
The FDA recommends that health care providers:
For details, please refer to the following FDA website:
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm629589.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 January 2019