Concept Medical Inc., a global leader in drug-delivery technology, has announced successful results from the groundbreaking SIRONA trial, the world’s first head-to-head comparison of Sirolimus and Paclitaxel drug-coated balloons for treating Peripheral Artery Disease (PAD) in the femoropopliteal artery.
The trial evaluated the efficacy of MagicTouch PTA Sirolimus-Coated Balloons (SCB) against seven Paclitaxel Drug-Coated Balloons (DCB) across 482 patients in 25 sites in Germany and Austria. The findings were presented at the TCT USA 2024 conference.
Key outcomes revealed that MagicTouch PTA achieved a primary patency rate of 73.8%, closely matching the 75% rate of Paclitaxel DCBs, confirming non-inferiority. Additionally, the trial demonstrated similar safety profiles, with 92.9% of MagicTouch patients and 95.4% of Paclitaxel patients avoiding clinically driven Target Lesion Revascularization (cdTLR) within 12 months. Functional improvements were also nearly identical, with 89% of patients in both groups showing significant advancements in their Rutherford stages.
“Sirolimus provides a viable alternative to paclitaxel-coated balloons, offering comparable efficacy and safety,” stated Prof. Ulf Teichgräber, Principal Investigator. Dr. Manish Doshi, Founder & Managing Director of Concept Medical, emphasized the company’s dedication to patient-centric innovations, marking a significant step forward in vascular therapy.
The SIRONA trial’s results offer a new horizon for PAD treatment, enabling physicians to personalize therapy and improve patient outcomes.