Concept Medical Inc. has announced positive results from the SIRONA (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery) randomized controlled trial, indicating that its MagicTouch PTA sirolimus-coated balloons (SCB) offer comparable patency and functional improvements to paclitaxel-coated balloons for individuals with peripheral artery disease (PAD). The one-year data were unveiled by Principal Investigator Prof. Ulf Teichgräber at the TCT USA 2024 conference.
The SIRONA trial was a prospective, multi-center, head-to-head RCT that enrolled 482 patients across 25 sites in Germany and Austria. The trial compared the MagicTouch PTA sirolimus-coated balloon against seven commercially available paclitaxel-coated balloons.
Key Findings from SIRONA
The SIRONA trial demonstrated that MagicTouch PTA achieved a primary patency rate of 73.8%, compared to 75% for paclitaxel DCBs. This slight difference of 1.2% met the non-inferiority efficacy endpoint for primary patency.
Safety analysis showed no significant difference in clinically-driven target lesion revascularization (cdTLR) at 12 months, with 92.9% in the MagicTouch PTA group and 95.4% in the paclitaxel group.
Both the sirolimus and paclitaxel groups exhibited similar improvements in functional outcomes, with an 89% improvement of >=1 Rutherford stage and many improving by >=2 stages, showing only a 0.1% difference between the groups.
Expert Commentary
"Historically, paclitaxel-coated balloon angioplasty has been the mainstay therapy for PAD, particularly in the femoropopliteal vascular segment, and is based on the 'leaving nothing behind' principle. However, safety concerns remain, so that emerging evidence supports the exploration of sirolimus as alternative drug option in the treatment of PAD. With the SIRONA RCT showing sirolimus to be as effective as paclitaxel, physicians may soon have more personalized approaches to address the wide-ranging needs of PAD patients," said Prof. Ulf Teichgräber.
Prof. Dierk Scheinert added, "After several positive signals from pre-clinical studies and smaller single arm investigations with sirolimus coated DCBs, the findings of the SIRONA RCT using the Head-to-Head randomization design represent the first level one evidence to support clinical efficacy of the Magic Touch sirolimus-coated DCB for a broad spectrum of femoropoliteal obstructions."
SIRPAD Trial and Future Directions
Concept Medical is also investigating MagicTouch PTA in the SirPAD (Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial treated with either sirolimus-coated or uncoated balloon) randomized controlled trial. SirPAD is the world's largest study evaluating the treatment of PAD using the MagicTouch PTA Sirolimus Coated Balloon versus uncoated balloons. The trial has completed enrollment of over 1,250 patients, with final results expected by Q1-Q2 2026. The primary outcome is major adverse limb events (MALE) assessed at 12 months.
"At Concept Medical, we are committed to generating robust clinical evidence to support our innovative technologies," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. "Following the successful completion of SIRONA...we are proud to announce the completion of enrollment for another historical milestone: the largest randomised clinical trial for peripheral all-comers patients, completed enrolment of 1250+ patients."
