LONDON, April 27, 2026 /PRNewswire/ -- Concept Medical Inc., today announced the presentation of preliminary 3-year follow-up data from the SIRONA randomised trial at the Charing Cross (CX) Symposium 2026, reinforcing its leadership in drug-delivery technologies for peripheral interventions.
The data were presented by Principal Investigator Prof. Ulf Teichgräber during a podium first session on '3-year results from the SIRONA randomised trial.'
SIRONA is a randomised controlled trial evaluating sirolimus-coated versus paclitaxel-coated balloon angioplasty in femoropopliteal artery disease, designed to generate robust head-to-head comparative evidence in a field historically dominated by paclitaxel-based therapies. Previously in JACC published 12-month results demonstrated non-inferiority across the trial's primary efficacy and safety endpoints.
In the current 3-year analysis, MagicTouch PTA, a sirolimus-coated balloon, showed higher freedom from clinically driven target lesion revascularization (cdTLR) compared with the paclitaxel-coated balloon group (88.2% vs 80.2%; HR 0.60; 95% CI 0.36-0.97; log-rank p=0.03). The results are pending Clinical Events Committee (CEC) adjudication. Taken together, these preliminary findings suggest that sirolimus-coated balloon angioplasty may provide more durable long-term outcomes than paclitaxel-coated balloon angioplasty.
At 3 years, Freedom of all-cause mortality remained comparable between treatment groups (92.6% vs 92.6%; HR 1.12; p=0.67), supporting a balanced long-term safety profile. Rates of Freedom of major amputation were low, with no statistically significant difference observed between groups (99.6% vs 99.6%;HR 0.54; p=0.61).
Prof. Ulf Teichgräber, Principal Investigator, said, "The preliminary 3-year SIRONA data are very exciting. Seeing a sustained reduced reduction in cdTLR with MagicTouch PTA over such a long follow-up period is highly encouraging and speaks to the durability of sirolimus-based drug delivery in femoropopliteal interventions. These findings add important long-term randomized evidence to the field and, pending final CEC adjudication, represent a very promising signal for the future role of sirolimus-coated balloons in peripheral artery disease. Importantly, these findings should not be interpreted as a class effect, but rather highlight the need to evaluate individual sirolimus-coated balloon technologies based on robust clinical evidence."
Dr Manish Doshi, Founder and Managing Director, Concept Medical, added, "For us, SIRONA represents the discipline of long-term clinical science, going beyond early outcomes to truly understand durability. These 3-year findings continue to strengthen the comparative evidence for sirolimus-coated balloon therapy. As we scale globally, our focus remains on generating high-quality, long-term data that clinicians can rely on with confidence."
About Concept Medical
Concept Medical Inc. is a global pioneer in drug-delivery technologies for vascular interventions. The company is headquartered in Florida, USA, with manufacturing operations in India. Its proprietary Nanolute technology platform is designed to enable controlled and sustained delivery of sirolimus across coronary and peripheral applications. The company's flagship product, MagicTouch, is among the most clinically studied sirolimus-coated balloon platforms worldwide.
Source: Data from the SIRONA randomised trial, presented by Prof. Ulf Teichgräber at the Charing Cross (CX) Symposium 2026, London, UK. Preliminary results prior to Clinical Events Committee (CEC) adjudication.
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