Concept Medical Inc. (CMI), a global leader in drug-delivery technologies for vascular interventions, has announced the presentation of the world’s largest randomized controlled trial evaluating a sirolimus-coated balloon (SCB) for peripheral artery disease (PAD) at the ACC 2026 Scientific Sessions.

The SirPAD trial results were presented as a Late-Breaking Clinical Trial by Prof. Dr. Stefano Barco of University Hospital Zurich, on behalf of the SirPAD Steering Committee and investigators. The findings have also been simultaneously published in the New England Journal of Medicine.

The investigator-led SirPAD trial enrolled 1,252 patients with femoropopliteal or below-the-knee PAD, who were randomized to receive either the MagicTouch PTA sirolimus-coated balloon or standard uncoated balloon angioplasty.

At one year, the primary endpoint of Major Adverse Limb Events (MALE)—including major unplanned amputations or target-lesion revascularization for critical ischemia—occurred in 8.8% of patients treated with MagicTouch PTA, compared to 15% in the uncoated balloon group. This translated to a significant risk reduction, demonstrating both non-inferiority and superiority of the sirolimus-coated balloon.

Additionally, the study reported a statistically significant reduction in key secondary endpoints, including unplanned target-limb amputations and revascularizations.

“This is one of the few trials in this space to include a true all-comers population, with nearly 50% of patients presenting acute or chronic limb-threatening ischemia. This design enabled robust clinical outcomes and sufficient statistical power to demonstrate superiority at one year,” said Prof. Dr. Nils Kucher and Prof. Dr. Stefano Barco, Co-Chairs of the trial.

The SirPAD trial marks a significant milestone in vascular intervention, positioning MagicTouch PTA as a promising future alternative for PAD treatment. It also adds to a growing body of evidence supporting sirolimus-coated balloon technology across both coronary and peripheral applications.

Supporting these findings, the SIRONA randomized controlled trial in femoropopliteal PAD has already demonstrated the non-inferiority of MagicTouch PTA compared to paclitaxel drug-coated balloons.

With the publication of SirPAD’s primary results, the study provides strong clinical evidence that sirolimus-coated balloons can improve outcomes in a broad patient population. These findings are expected to influence future treatment guidelines and expand therapeutic options for physicians.

“SirPAD represents a major milestone for the PAD community and the evolution of sirolimus-coated balloon therapy. The validation of MagicTouch PTA through a large, investigator-led randomized trial and peer-reviewed publication underscores our commitment to evidence-based innovation,” said Dr. Manish Doshi, Founder and Managing Director of Concept Medical and inventor of MagicTouch.