Guidance

Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons and Drug-Eluting Stents to the MHRA

The findings and recommendations of the Expert Advisory Group on paclitaxel drug-coated balloon catheters and drug-eluting stents which are used to treat patients with peripheral arterial disease.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 3 June 2019
• Last updated: 18 February 2021 — See all updates

Documents

Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stents (DESs) to the MHRA

PDF, 229 KB, 12 pages

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Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug Coated Balloons (DCBs) and Drug Eluting Stents (DESs) to the MHRA

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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.

Published 3 June 2019
Last updated 18 February 2021 + show all updates

1. 18 February 2021

   Updated following review of new evidence in 2020 (no change to advice).

2. 4 June 2019

   Updated to include link to MHRA's MDA on the issue.

3. 3 June 2019

   First published.