Promising Results for Sirolimus-Coated Balloons in Treating Peripheral Arterial Disease

Groundbreaking Study on Sirolimus-Coated Balloons for PAD

In a significant development in vascular intervention, Concept Medical Inc. recently unveiled the results of the SirPAD study at the 2026 American College of Cardiology (ACC) conference. This pivotal study is recognized as the largest randomized controlled trial focused on the application of sirolimus-coated balloons for the treatment of Peripheral Arterial Disease (PAD).

The primary findings were presented by Professor Stefano Barco of the University Hospital Zurich, representing the SirPAD steering committee and participating researchers. Simultaneously, these crucial results were published in the prestigious New England Journal of Medicine, underscoring the study's importance.

Key Findings from the SirPAD Study

The SirPAD study involved 1,252 participants suffering from femoropopliteal or below-the-knee PAD. Patients were randomized to receive either the sirolimus-coated MagicTouch PTA balloon or a non-coated balloon angioplasty. The main endpoint of the study measured Major Adverse Limb Events (MALE), which includes significant unplanned amputations of the targeted limb or the need for revascularization due to critical ischemia.

After one year, the results revealed that only 8.8% of patients treated with the sirolimus-coated balloon experienced MALE, compared to 15% in the control group using the uncoated balloon. This translates to a median unadjusted risk difference of -4.9%. The study not only met the criteria for non-inferiority but also demonstrated superiority for the MagicTouch PTA (Concept Medical Inc.) compared to the uncoated balloon. Moreover, findings indicated a statistically significant reduction in the composite secondary endpoint that included unplanned amputations or revascularization needs.

Importance of the Study

The investigators expressed their enthusiasm about the primary endpoints’ results from the SirPAD study, marking it as one of the few studies to successfully encompass an