In 2019, the FAMHP published recommendations for the use of paclitaxel-coated balloons and paclitaxel-eluting stents. The European Commission recently published a scientific advice from an expert panel. The expert panel's advice contains no new elements that change the previous recommendations.
Following a safety signal, the FAMHP published recommendations in 2019 for the use of paclitaxel-coated balloons (drug-coated balloons, DCBs) and paclitaxel-eluting stents (drug-eluting stents, DESs) in the treatment of peripheral arterial disease (PAV). As part of the further evaluation of this safety signal, an expert panel was consulted by the European Commission's Medical Device Coordination Group (MDCG). The European Commission recently published the expert panel's scientific advice.
The expert panel's advice contains no new elements that change the previous recommendations. Thus, the 2019 recommendations remain applicable.
- Do not use paclitaxel DCBs or DESs as a preferred treatment for intermittent claudication until futher notice. Carefully estimate the risks and benefits for each patient.
- Discuss the risks and benefits of all available treatment options for PAV with patients. Inform patients about the uncertainty of increased mortality.
- Ensure proper follow-up for patients who have already been treated with a paclitaxel DCB or DES.
- Report any adverse event involving a paclitaxel DCB or DES to FAMHP using our online adverse event form.
Patients who have any questions or doubts about these devices should talk to their attending physician.
More information
Scientific advice on paclitaxel-coated balloons and paclitaxel-eluting stents