Concept Medical Inc., a global leader in drug-delivery technologies for vascular interventions, presented the preliminary three-year follow-up data from the SIRONA trial at the Charing Cross (CX) Symposium 2026.

Principal Investigator Prof. Ulf Teichgräber showcased the data during a podium session focused on long-term clinical outcomes.

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)—a segment historically dominated by paclitaxel-based therapies.

Earlier 12-month results, published in the Journal of the American College of Cardiology, demonstrated non-inferiority across key safety and efficacy endpoints. The newly presented three-year analysis offers deeper insights into long-term durability.

Findings showed that MagicTouch PTA, a sirolimus-coated balloon (SCB), achieved 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, but overall suggest improved long-term outcomes with sirolimus-based therapy.

Safety outcomes remained consistent across both treatment arms. Freedom from all-cause mortality was identical at 92.6% in both groups, while major amputation rates were similarly 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. 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.”