Concept Medical Inc., a global leader in innovative drug delivery technologies, is proud to report positive results from the SIRONA (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting BallooNA) studyngioplasty in the femoropopliteal artery, to German: Direct comparison of SIROlimus and paclitaxel-coated balloNAngioplasties in the femoropopliteal artery) RCTs, showing that the sirolimus-coated balloons (SCB) (MagicTouch-PTA) in patients with peripheral artery disease (PAD) provide patency and functional benefits comparable to those of paclitaxel-coated balloons are comparable. The data from the first year were presented by lead researcher Prof. Ulf Teichgräber at the TCT USA 2024 conference in a Late-Breaking Clinical Trials Session (LBCT). TCTMD has reported these findings, highlighting sirolimus-based therapy as a viable new option in femoropopliteal procedures.

The prospective, multicenter, core-lab-reviewed RCT included a total of 482 patients at 25 sites in Germany and Austria and compared the MagicTouch PTA Sirolimus coated balloon to seven commercially available paclitaxel-coated balloons.

• Primary patency: SIRONA concluded that MagicTouch PTA achieved a primary patency of 73.8% compared to 75% for paclitaxel DCBs, representing a difference of only 1.2% and meeting the non-inferiority efficacy endpoint of primary patency.

• Favorable safety profile: SIRONA shows no significant difference in clinically-driven target lesion revascularization (cdTLR) at 12 months with 92.9% (MagicTouch PTA) and 95.4% (paclitaxel group).

• Functional improvements: SIRONA showed similar improved functional outcomes in both the sirolimus and paclitaxel groups, with a 0.1 difference between them and an 89% improvement in ≥1 Rutherford stage and ≥2 stages in many.

"Historically, paclitaxel-coated balloon angioplasty has been the main therapy for PAD, particularly in the femoropopliteal vascular segment, and is based on the 'leave nothing behind' principle. However, safety concerns remain, so recent findings support research into sirolimus as an alternative drug option in the treatment of peripheral arterial disease. Since SIRONA RCT has shown that sirolimus is as effective as paclitaxel, physicians may soon have further personalized approaches available to address the diverse needs of patients with peripheral arterial disease," says Prof. Ulf Teichgräber.

Prof. Dierk Scheinert, who has supported and promoted the RCT, stated after the exciting results: "After several positive signals from preclinical studies and smaller single-arm investigations with sirolimus-coated DCBs, the results of the SIRONA RCT with the head-to-head randomization design represent the first Level 1 evidence of the clinical efficacy of the Magic Touch Sirolimus-coated DCB for a wide range of femoropoliteal obstructions."