Warnings over paclitaxel-coated devices in vascular interventions

Tuesday 4 June 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (4 June) issued a Medical Device Alert regarding paclitaxel-coated balloons and stents used in vascular interventions.

There has been a significant safety concern over the use of paclitaxel-coated balloons and paclitaxel-eluting stents in treating peripheral vascular disease of the lower limbs, following meta-analysis by interventional radiology researchers, published in the Journal of the American Heart Association. 

These findings suggested there is an increased risk of death from two-to-five years, following interventions using these devices.

The MHRA formed an independent Expert Advisory Group (EAG) to review the complex information related to these devices. The review has been completed and the EAG report has made several recommendations. The MHRA has now issued a Medical Device Alert providing specific safety information on the use of these devices. 

Healthcare professionals, in particular interventional radiologists and vascular surgeons, are advised to review their practices based on the MHRA recommendations.