SirPAD trial shows reduced major adverse limb events at 1 year with sirolimus-coated MagicTouch balloon for PAD; NEJM publication after ACC 2026 presentation

Concept Medical Inc. (CMI) said that at ACC 2026, results from the SirPAD study—a large randomized controlled trial evaluating a sirolimus-coated balloon for peripheral arterial disease (PAD)—were presented and simultaneously published in the New England Journal of Medicine.

SirPAD trial design and patient population

The SirPAD study enrolled 1,252 patients with femoropopliteal or below-the-knee PAD. Participants were randomized to treatment with the sirolimus-coated balloon MagicTouch PTA or angioplasty using an uncoated balloon.

Primary outcome: major adverse limb events

The primary endpoint was major adverse limb events (MALE), defined as major amputation of the target extremity or revascularization of the target lesion in critical limb ischemia. At one year, MALE occurred in 8.8% of patients in the sirolimus-coated balloon group versus 15% in the uncoated balloon group. The median unadjusted risk difference was -4.9%.

Concept Medical said the difference was non-inferior and superior in favor of MagicTouch PTA compared with the uncoated balloon.

Secondary outcome: reduction in composite events

The authors also reported a statistically significant reduction in a composite secondary endpoint, consisting of an unplanned amputation of the target limb or a revascularization of the target limb.

All-comers cohort and statistical power

Concept Medical highlighted that SirPAD included an “All-Comers” cohort, described as consecutive patients without inclusion criteria based on characteristics of the target lesion or PAD stage. The company said this resulted in nearly 50% of enrolled patients having acute or chronic limb-threatening ischemia, which it said provided sufficient events and statistical power to demonstrate superiority for hard clinical endpoints at one year.

Implications and context

Concept Medical said the SirPAD primary analysis adds evidence that a sirolimus-coated balloon improves clinical outcomes in an All-Comers population, which could influence future guidelines and broaden treatment options for physicians.

The company also referenced the SIRONA RCT in femoropopliteal PAD, which compared MagicTouch PTA with paclitaxel drug-coated balloons (DCBs) and confirmed non-inferiority.

Statements from study leadership and company executives

Prof. Dr. med. Nils Kucher and Prof. Dr. Stefano Barco, co-chairs of the SirPAD study, said the trial was among the few in the field to successfully include an All-Comers cohort and that this supported the demonstration of superiority for hard clinical endpoints at one year.

Dr. Manish Doshi, founder and CEO of Concept Medical and inventor of MagicTouch, said the evaluation of MagicTouch PTA in a large investigator-led randomized study, supported by peer-reviewed publication, reinforces the company’s view that innovations should be validated through rigorous scientific methods.

Publication and presentation

Concept Medical said the trial results were presented as a Late-Breaking Clinical Trial at ACC 2026 on March 30, 2026, in New Orleans, Louisiana, and were published simultaneously in the New England Journal of Medicine.

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