London, April 29: Concept Medical Inc., a global leader in drug-delivery technologies for vascular interventions has announced the presentation of preliminary 3-year follow-up data from the SIRONA trial at the Charing Cross (CX) Symposium 2026.
The data were presented by Principal Investigator Prof. Ulf Teichgräber during a podium session focused on long-term outcomes from the study.
SIRONA is a randomised controlled trial (RCT) comparing sirolimus-coated balloon (SCB) angioplasty with paclitaxel-coated balloon (PCB) angioplasty in patients with femoropopliteal artery disease (FAD), an area traditionally dominated by paclitaxel-based therapies.
Earlier 12-month results, published in Journal of the American College of Cardiology, demonstrated non-inferiority across key safety and efficacy endpoints. The latest three-year analysis now provides insights into long-term durability.
The findings showed that MagicTouch PTA, a sirolimus-coated balloon (SCB), delivered higher freedom from clinically driven target lesion revascularization (cdTLR) compared to paclitaxel-coated balloons (PCB) (88.2% vs 80.2%; HR 0.60; p=0.03). These results are pending adjudication by the Clinical Events Committee. Overall, the data suggest improved long-term outcomes with sirolimus-based therapy.
Safety outcomes remained consistent between both groups. Freedom from all-cause mortality was identical at 92.6% in both arms, while major amputation rates were low and comparable (99.6% vs 99.6%), reinforcing a balanced safety profile.
Commenting on the findings, Prof. Teichgräber said
“The sustained reduction in revascularization rates highlights the durability of sirolimus-based drug delivery. He noted, “While the results are encouraging, evaluation of individual technologies remains critical.”
Manish Doshi, Founder & Managing Director (MD), added
“The trial reflects the company’s focus on long-term clinical evidence and strengthening confidence in sirolimus-coated balloon therapies as they expand globally.”
