SirPAD: Primary results confirm safety and efficacy of sirolimus-coated balloon in peripheral arterial disease

Concept Medical Inc. (CMI) said it presented at ACC 2026 results from what it describes as the world’s largest randomized trial of a sirolimus-coated balloon for peripheral arterial disease (SirPAD). The primary results were presented by Prof. Dr. Stefano Barco of University Hospital Zurich on behalf of the SirPAD steering committee and investigators, and were published simultaneously in the New England Journal of Medicine (NEJM).

Trial design and patient population

The SirPAD study enrolled 1,252 patients with femoropopliteal or popliteal disease. Participants were randomized to receive either the sirolimus-coated MagicTouch PTA balloon or an uncoated balloon.

Primary results

The primary endpoint was major limb adverse events (MALE), defined to include major amputations of the target limb or lesion-targeted revascularization for critical limb ischemia. At one year, MALE occurred in 8.8% of patients in the sirolimus-coated group versus 15% in the uncoated group. This corresponded to a median unbiased estimate of the difference in risk of -4.9 percentage points, favoring MagicTouch PTA over the uncoated balloon.

Secondary outcomes

The authors also reported a statistically significant reduction in a secondary composite endpoint, which included any non-planned amputation of the target limb or any revascularization of the target limb.

Real-world “all-comers” evidence

Investigators said SirPAD was among the few trials in this field to include a real-world, all-comers population. They reported that nearly 50% of patients presented with acute or chronic limb-threatening ischemia, which they said enabled sufficient events and statistical power to show clinical benefits at one year.

Context and potential impact

Prof. Nils Kucher and Prof. Stefano Barco described SirPAD as a “game-changing” trial for vascular intervention and for sirolimus-coated balloon therapy as a future therapeutic option. Concept Medical said MagicTouch PTA is the most studied drug-coated balloon and underpins the highest clinical evidence in both coronary and peripheral disease. The company also referenced the SIRONA trial, conducted recently for femoropopliteal PAD comparing paclitaxel-coated balloons, which it said confirmed the non-inferiority of MagicTouch PTA.

Company and inventor comments

Dr. Manish Doshi, founder and chief executive of Concept Medical and inventor of MagicTouch, said SirPAD is an important milestone for the MAP community and the ongoing evolution of sirolimus-coated balloon therapy. He added that the large randomized study and peer-reviewed publication reinforce the view that meaningful innovation must be validated by rigorous data.

Doshi expressed gratitude to the researchers, study teams, and patients who participated in the study.

Source and regulatory note

Concept Medical said the data were presented as a late-breaking trial at ACC’s 75th conference by Prof. Stefano Barco on March 30, 2026, in New Orleans, Louisiana, and published simultaneously in NEJM.

Disclaimer: The law restricts these devices to sale by a physician or on his order. Indications, contraindications, warnings and instructions for use are contained in the labeling provided with each device. Use is restricted to countries where the product is registered with the competent health authorities. MagicTouch PTA is an experimental device approved by the US FDA for use only in clinical trials.