BfArM, the German Federal Institute for Drugs and Medical Devices, recently published a warning notice for patients, users and manufacturers of stents and balloons that are coated with Paclitaxel.
A meta-analysis of randomized controlled trials (RCTs) showed that patients treated with these products in the femoropopliteal artery of the lower limbs had a significantly increased risk of death compared to patients who have been treated with uncoated balloons or bare metal stents.
Manufacturers of these products are recommended to take into account the results of the analysis when reviewing the marketability of their devices – in cooperation with the Notified Bodies. Corrective actions should be reported to the competent authorities.
It is necessary to generate additional long-term data. For this purpose, follow-up with patients of already completed RCTs can be resumed.
Should you require the direct link to the above-mentioned analysis, please let us know.