# Paclitaxel drug-coated balloons and drug-eluting stents

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/d64e1b34-766d-4bc6-8264-e0024d8d99ae
Type: Guidance
Published: June 3, 2019
Updated: March 3, 2026

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated clinical guidance regarding the use of paclitaxel-coated devices (PCD) for treating peripheral arterial disease (PAD). Following a review of mortality data by the Expert Advisory Group (EAG), the MHRA recommends that these devices should no longer be used to treat patients with intermittent claudication due to the availability of safer alternatives. For patients with critical limb ischaemia, PCDs may still be considered if the clinical benefits outweigh the risks, in accordance with NICE guidelines. The regulatory framework emphasizes patient safety and data transparency. Required actions include establishing enhanced follow-up protocols for all patients receiving these implants. Furthermore, the MHRA mandates reporting of any adverse events through the Yellow Card scheme for patients or national reporting systems for healthcare professionals in England, Scotland, Wales, and Northern Ireland. While this document does not cite a specific company or inspection date, it represents a formal safety update published in February 2024 under reference DSI/2024/001. This directive ensures that the use of paclitaxel-coated technology is limited to high-risk cases where clinical necessity is clearly demonstrated.

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## Content

The EAG recommended that these devices are not used to treat patients with intermittent claudication (a pain in the leg caused by the lack of blood flow). This is a condition that may be treated effectively with other devices and therapies. The devices may still be considered in patients with critical limb ischaemia (severe obstruction of the arteries), where it is felt that the benefits outweigh the risks and taking NICE guidance into account. If these devices are to be used there should be enhanced patient follow-up. The MHRA encourages anyone – patient, carer or healthcare professional, who knows of a safety problem or adverse event that is or might be linked to a medical device, to report to us. Patients can report via the Yellow Card scheme . Healthcare professionals should report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England , Scotland , Northern Ireland , Wales . Post-publication note In February 2024, following additional review by the MHRA of more recent and comprehensive published mortality data, comparing the use of paclitaxel coated devices (PCD) to non-paclitaxel coated devices (nPCD) in the treatment of peripheral arterial disease (PAD), we have updated our guidance - see DSI/2024/001 .

## Attachments

- [Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug Coated Balloons (DCBs) and Drug Eluting Stents (DESs) to the MHRA](/government/publications/recommendations-from-the-independent-expert-advisory-group-on-the-use-of-paclitaxel-drug-coated-balloons-dcbs-and-drug-eluting-stents-dess-to-the/recommendations-from-the-independent-expert-advisory-group-on-the-use-of-paclitaxel-drug-coated-balloons-dcbs-and-drug-eluting-stents-dess-to-the)