Innovative Sirolimus Balloons Rival Paclitaxel: SIRONA Trial Findings

SIRONA trial reveals that sirolimus-coated balloons by Concept Medical match the efficacy of paclitaxel-coated balloons for peripheral artery disease. Conducted in Germany and Austria, the RCT confirmed non-inferiority, favorable safety, and functional outcomes, suggesting a viable alternative for femoropopliteal interventions.

Concept Medical Inc. has announced positive results from the SIRONA trial, highlighting the potential of sirolimus-coated balloons as a viable alternative for treating peripheral artery disease (PAD). The findings were disclosed during a late-breaking session at the TCT USA 2024 conference.

The rigorous RCT compared the performance of Concept Medical's MagicTouch PTA sirolimus-coated balloon against paclitaxel-coated balloons across 25 sites in Germany and Austria, with 482 participants enrolled. It concluded that MagicTouch PTA achieved comparable primary patency and safety profiles, meeting the non-inferiority efficacy endpoint.

Experts assert the trial represents the first level one evidence supporting the clinical efficacy of sirolimus-coated DCBs, signaling a possible shift in treatment protocols. Concept Medical remains committed to innovation in vascular therapy, reinforcing its leadership in drug-delivery technology.

(With inputs from agencies.)