SIRONA is a randomised controlled trial comparing sirolimus-coated balloon angioplasty
with paclitaxel coated balloon angioplasty in patients with femoropopliteal artery disease,

an area traditionally dominated by paclitaxel based therapies.

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.”