MagicTouch PTA Sirolimus Balloons Prove Effective In PAD Treatment: SIRONA Trial Results

Concept Medical, a pioneer in drug-delivery technology, has reported positive results from the SIRONA trial, the world’s first head-to-head comparison of Sirolimus-Coated Balloons (SCBs) with Paclitaxel Drug-Coated Balloons (DCBs) in treating Peripheral Artery Disease (PAD). The findings, presented by Principal Investigator Prof. Ulf Teichgräber during the Late-Breaking Clinical Trials Session at the TCT USA 2024 conference, highlight SCBs as a viable alternative for femoropopliteal interventions.

The prospective, multi-centre, core lab adjudicated randomised controlled trial (RCT) enrolled 482 patients across 25 sites in Germany and Austria. MagicTouch PTA SCBs were compared against seven commercially available Paclitaxel DCBs.

Key Findings from the SIRONA Trial:

• Primary Patency: MagicTouch PTA SCBs achieved a primary patency rate of 73.8 per cent, comparable to the 75 per cent achieved by Paclitaxel DCBs, meeting the non-inferiority endpoint.

• Safety Profile: Clinically-driven Target Lesion Revascularisation (cdTLR) rates showed no significant difference, with SCBs at 92.9 per cent and DCBs at 95.4 per cent at 12 months.

• Functional Improvements: Both groups demonstrated similar functional outcomes, with 89 per cent of patients improving by at least one Rutherford stage and many by two or more stages.

“Paclitaxel-coated balloon angioplasty has been a standard for PAD in the femoropopliteal segment but comes with safety concerns,” noted Prof. Ulf Teichgräber. “The SIRONA trial demonstrates that sirolimus is an equally effective alternative, paving the way for more personalised PAD treatments.”

Supporting the results, Prof. Dierk Scheinert added, “These findings provide the first level-one evidence for the clinical efficacy of sirolimus-coated DCBs in a broad range of femoropopliteal obstructions.”

Dr. Manish Doshi, Founder and Managing Director of Concept Medical, emphasised the company’s dedication to innovation. “The SIRONA trial underscores our commitment to delivering patient-centric, evidence-based solutions that improve PAD care and outcomes.”