UK – UK discourages use of paclitaxel devices for intermittent claudication

  • The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) cast further doubt Tuesday on safety and effectiveness of paclitaxel-administering devices with new recommendations to healthcare providers informed by its expert advisory group (EAG). MHRA formed the investigative group in March to assess the devices’ safety, using data fromBard (BD), Biotronik, Cook, Medtronic and others.
  • « Do not use paclitaxel drug coated balloons (DCBs) or drug eluting stents (DESs) in the routine treatment of patients with intermittent claudication until further notice, as the potential mortality risk generally outweighs the benefits, » the regulatory body said in the notice to surgeons and radiologists.
  • MHRA noted the benefits of paclitaxel DCBs and DESs may outweigh risks in patients with critical limb ischaemia, given the population’s higher risk of irreversible ischemic damage resulting from restenosis and lower life expectancy. The regulatory body said it will also share a review of results from clinical trials examining use of the devices in patients with arterio-venous fistula once available…