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LONDONApril 28, 2026 /PRNewswire/ — Concept Medical Inc. today announced that it will present the preliminary 3-year follow-up data from the SIRONA randomized trial at the 2026 Charing Cross (CX) Symposium, further solidifying its leadership in drug delivery technology for peripheral interventions.
Preliminary 3-year data from SIRONA presented at CX-2026 demonstrate durable reintervention-free outcomes with MagicTouch PTA in treating femoropopliteal disease
These data were presented by Professor Ulf Teichgräber, Principal Investigator, in the first session of the conference, titled “3-Year Results of the SIRONA Randomized Trial.”
SIRONA is a randomized controlled trial designed to evaluate the effects of sirolimus-coated balloons versus paclitaxel-coated balloon angioplasty in the treatment of femoropopliteal artery disease, aiming to provide robust head-to-head comparative evidence in a field historically dominated by paclitaxel-based therapies. Previously published 12-month results in JACC demonstrated non-inferiority in both primary efficacy and safety endpoints.
In this 3-year analysis, MagicTouch PTA, a sirolimus-coated balloon, showed superiority over the paclitaxel-coated balloon group in terms of clinically driven target lesion revascularization (cdTLR) rates (88.2% vs 80.2%; HR 0.60; 95% CI 0.36–0.97; log-rank p=0.03). Results are subject to adjudication by the Clinical Events Committee (CEC). Collectively, these preliminary findings suggest that sirolimus-coated balloon angioplasty may offer more durable long-term efficacy compared to paclitaxel-coated balloon angioplasty.
At the 3-year follow-up, all-cause mortality remained comparable between treatment groups (92.6% vs 92.6%; HR 1.12; p=0.67), indicating a balanced long-term safety profile. Major amputation rates were low, with no statistically significant difference observed between the two groups (99.6% vs 99.6%;HR 0.54; p=0.61).
Professor Ulf Teichgräber, Principal Investigator, stated: “The preliminary 3-year data from SIRONA are very encouraging. Observing a sustained reduction in cdTLR with MagicTouch PTA over such an extended follow-up period is promising and underscores the durability of sirolimus delivery systems in femoropopliteal interventions. These findings provide important long-term randomized controlled evidence for the field, and pending final CEC adjudication, they point to a very promising outlook for sirolimus-coated balloons in treating peripheral artery disease. Importantly, these results should not be interpreted as a class effect, but rather emphasize the need to evaluate individual sirolimus-coated balloon technologies based on robust clinical evidence.”
Dr. Manish Doshi, Founder and Managing Director of Concept Medical, added: “For us, SIRONA represents the rigor of long-term clinical science—not just focusing on early efficacy, but truly understanding durability. These 3-year results further strengthen the comparative evidence for sirolimus-coated balloon therapy. As we expand our global footprint, our focus remains on generating high-quality, long-term data that clinicians can rely on with confidence.”