Paclitaxel drug-coated balloons and drug-eluting stents
Recommendations from the independent Expert Advisory Group to the MHRA on the use of paclitaxel balloon catheters and stents to treat peripheral arterial disease.
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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.
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.
Updates to this page
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Replaced PDF attachment with an html version and added a post-publication note.
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Updated following review of new evidence in 2020 (no change to advice).
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Updated to include link to MHRA's MDA on the issue.
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First published.