- The phase 3 SirPAD trial randomized 1,252 patients with symptomatic infrainguinal peripheral artery disease to sirolimus-coated or uncoated balloon angioplasty. - At one year, the primary composite endpoint of major target-limb amputation or target-lesion revascularization for chronic limb-threatening ischemia occurred in 8.8% versus 15%. - The key secondary composite endpoint of any unplanned amputation or revascularization occurred in 23% with sirolimus-coated balloons versus 30.8% with uncoated balloons. - One-year all-cause mortality was similar between groups at 11.8% versus 12.8%, offering short-term safety reassurance for the sirolimus platform.

Jun 30, 2026

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Biotronik AG

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SirPAD: Sirolimus-Coated Balloons Cut Amputation and Revascularization in Infrainguinal PAD