MHRA Updates Guidelines on the Use of Paclitaxel-Coated Devices for Treating PAD

February 12, 2024—The United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) recently updated its guidance on the use of paclitaxel-coated devices (PCDs) for the treatment of peripheral artery disease (PAD).

Following an extensive review of recent literature and the advice of the Interim Devices Working Group (IDWG), MHRA removed restrictions on indication, dose, and repeated exposure. The new guidelines from MHRA now state that where indicated, PCD can be considered as a treatment option for both critical limb ischemia (CLI) and intermittent claudication (IC) patients.

This update comes several months after the United States FDA had also determined there was no excess mortality risk found in patients treated with PCDs in July 2023.

MHRA provided the following actionable items that health care professionals in the UK can take when considering PCD:

• PCD can be considered (where indicated) as a clinical treatment option for patients experiencing PAD, including patients with CLI or IC.
• Previous MHRA advice relating to the use of the lowest dose PCD available and to avoid/reduce repeated exposure of PCDs is withdrawn.
• Routine patient follow-up should continue as per standard of care.
• Direct any suspected adverse incidents associated with PCD to your national reporting system.
• When reporting suspected adverse incidents, include the following information:
  • Details of the device, including manufacturer, model, and batch number
  • Details of problems with the device and when the problems started
• To assist with the capture of long-term, high-quality follow-up outcomes data for possible future evaluation, please ensure details are completed utilizing the National Vascular Registry and also the Outcomes and Registries Programme for follow-up outcomes in England.