#USA #London #Concept Medical #Sirolimus #SIRONA Study

Preliminary Three-Year Data from SIRONA Study at CX 2026

Concept Medical Inc. recently unveiled the preliminary results from the long-term follow-up of the randomized SIRONA study during the Charing Cross Symposium 2026. This significant presentation underscores the advancements in drug delivery technologies specific to peripheral interventions, reinforcing Concept Medical's status as a frontrunner in this domain. Professor Ulf Teichgräber, the study lead, presented the data during a panel discussion focused on the “Three-Year Outcomes from the Randomized SIRONA Study.”

Highlights from the SIRONA Study

The SIRONA study represents a pivotal randomized controlled trial that compares Sirolimus-coated balloon angioplasty with Paclitaxel-coated balloon angioplasty in patients with femoropopliteal artery disease. This study is noteworthy as it aims to establish robust comparative data in a field historically dominated by Paclitaxel-based treatments. Previous 12-month results, published in the Journal of the American College of Cardiology, exhibited non-inferiority with regard to the primary efficacy and safety endpoints.

In the recent three-year analysis, the MagicTouch PTA, a Sirolimus-coated balloon, demonstrated a statistically significant advantage in the rates of clinically indicated target lesion revascularization (cdTLR) when compared with the Paclitaxel-coated balloon group. The numbers showed an impressive freedom rate of 88.2% for the Sirolimus group versus 80.2% for the Paclitaxel group (HR 0.60; 95% CI 0.36-0.97; log-rank p=0.03). Importantly, these outcomes are still pending review by the Clinical Events Committee (CEC).

These preliminary findings suggest that Sirolimus-coated balloon angioplasty may lead to more durable long-term results than its Paclitaxel counterpart. Mortality rates remained comparable between treatment groups at three years (92.6% vs. 92.6%; HR 1.12; p=0.67), reinforcing a balanced long-term safety profile. The occurrence of major amputation rates was low, with no statistically significant distinction between the groups (99.6% vs 99.6%; HR 0.54; p=0.61).

Expert Insights

Professor Ulf Teichgräber remarked, “The preliminary three-year data from SIRONA is very intriguing. The sustained reduction in cdTLR rates with the MagicTouch PTA over such an extended follow-up period is incredibly encouraging, indicating the durability of Sirolimus-based drug delivery in femoropopliteal procedures. These results provide vital long-term randomized evidence for this field and represent a promising signal for the future role of Sirolimus-coated balloons in treating peripheral arterial occlusive diseases.”

Dr. Manish Doshi, the founder and CEO of Concept Medical, added, “To us, SIRONA symbolizes the discipline of clinical science over the long term, comprehending durability beyond early results. These three-year outcomes continue to bolster the comparative evidence supporting Sirolimus-coated balloon therapy. While we expand 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 recognized as a global pioneer in drug delivery technologies for vascular intervention. Headquartered in Florida, USA, with manufacturing facilities in India, the company’s proprietary Nanolute™ technology platform is crafted to enable controlled and sustained Sirolimus release for both coronary and peripheral applications. Its flagship product, MagicTouch, ranks among the world’s best-studied Sirolimus-coated balloon platforms.

This presentation of preliminary results from the randomized SIRONA study by Professor Ulf Teichgräber at the Charing Cross Symposium in London offers a forward-looking perspective on drug-coated balloons, especially for treating vascular conditions effectively and safely.