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# UK Caution on Some Balloons, Stents
- URL: https://www.fdaweb.com/uk-caution-on-some-balloons-stents/
- Published: 2019-06-06T12:00:00.000Z
- Updated: 2026-09-15T01:31:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144276

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) says doctors should not use paclitaxel drug-coated balloons or drug-eluting stents in routine treatment of patients with intermittent claudication until further notice, as the potential mortality risk outweighs the benefits. An agency [medical device alert](https://www.gov.uk/drug-device-alerts/recommendations-for-ongoing-use-of-paclitaxel-drug-coated-balloons-dcbs-and-implantable-drug-eluting-stents-dess-in-the-treatment-of-patients-with-peripheral-artery-disease-pad-mda-2019-023?ref=fdaweb.com) says use of the balloons and stents in patients with critical limb ischemia remains an appropriate option as the benefits may outweigh the risks because such patients generally have a higher risk of irreversible ischemic damage resulting from restenosis, and a lower life expectancy.

The notice says a 12/2018 meta-analysis published in the *Journal of the American Heart Association* highlighted a statistically significant all-cause mortality from two to five years post-treatment, compared with patients treated with plain balloons or bare-metal stents. “These findings raised significant concerns on their use in routine clinical practice and clinical trials,” MHRA says. The agency formed an independent expert advisory group that recently made recommendations.

FDA issued a similar safety [alert](https://www.fdaweb.com/fda-finds-increased-mortality-with-paclitaxel-devices/) earlier this year.