CONCEPT MEDICAL ANNOUNCES PRELIMINARY 3-YEAR SIRONA DATA AT CHARING CROSS SYMPOSIUM 2026

2026-04-27 02:07:34

(MENAFN- EQS Group)

Concept Medical / Key word(s): Miscellaneous
CONCEPT MEDICAL ANNOUNCES PRELIMINARY 3-YEAR SIRONA DATA AT CHARING CROSS SYMPOSIUM 2026
27.04.2026 / 12:50 CET/CEST
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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 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 NanoluteTM technology platform 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. Photo:
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