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IRIC safety alert

MHRA Medical Device Safety Information – MDSI2401

Published on 05 February 2024

From: Health Facilities Scotland

MDSI2401 - Paclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease: update to previous MHRA guidance on use.



The MHRA has updated its previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD). The MHRA conducted an extensive review of the most recent published literature and sought the advice of the Interim Devices Working Group (IDWG) and invited experts. Following this review, the MHRA has updated its previous advice on PCD to remove restrictions on indication, dose, and repeated exposure. Where indicated, PCD can be considered a treatment option in patients with critical limb ischaemia (CLI) or intermittent claudication (IC). Previous MHRA advice relating to the use of the lowest dose PCDs available and to avoid or reduce repeated exposure of paclitaxel coated devices is withdrawn.