LONDON, April 27, 2026 /PRNewswire/ -- , today announced the presentation of preliminary 3-year follow-up data from the , reinforcing its leadership in drug-delivery technologies for peripheral interventions.
The data were presented by during a podium first session on '3-year results from the SIRONA randomised trial.'
, designed to generate robust head-to-head comparative evidence in a field historically dominated by paclitaxel-based therapies. Previously in demonstrated non-inferiority across the trial's primary efficacy and safety endpoints.
In the current 3-year analysis, , a sirolimus-coated balloon, showed compared with the paclitaxel-coated balloon group (). The results are pending . 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 between treatment groups (), supporting a balanced long-term safety profile. Rates of Freedom of , with between groups ( ).
, Principal Investigator, said, "The preliminary 3-year SIRONA data are very exciting. Seeing a sustained reduced reduction in cdTLR with 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."
, 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."
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 is designed to enable controlled and sustained delivery of sirolimus across coronary and peripheral applications. The company's flagship product, , is among the most clinically studied sirolimus-coated balloon platforms worldwide.
Data from the , presented by at the , London, UK. Preliminary results prior to Clinical Events Committee (CEC) adjudication.
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