- Concept Medical reports & announces successful & positive trial result outcomes from the SIRONA (World’s First Head-to-Head Comparison of Sirolimus v/s Paclitaxel in Femoropopliteal Artery).
- MagicTouch PTA Sirolimus-Coated-Balloons provide patency & functional benefits on par with Paclitaxel Drug-Coated-Balloons for patients suffering from Peripheral Artery Disease.
Tampa, Florida – Concept Medical Inc., a global leader in innovative drug-delivery technology, proudly reports and announces successful and positive trial result outcomes from the SIRONA (World’s First Head-to-Head Comparison of Sirolimus v/s Paclitaxel in Femoropopliteal Artery) which show that it’s MagicTouch PTA Sirolimus-Coated-Balloons (SCB) provide patency and functional benefits on par with Paclitaxel Drug-Coated-Balloons (DCB) for patients suffering from Peripheral Artery Disease (PAD). The 1-year data was presented by Principal Investigator Prof. Ulf Teichgräber at the TCT USA 2024 conference in a Late‑Breaking Clinical Trials Session (LBCT). Coverage by TCTMD has highlighted these findings, underscoring sirolimus-based therapy as a viable new option in femoropopliteal interventions.
The prospective, multi-center, head-to-head, core lab adjudicated RCT enrolled a total of 482 patients across 25 sites in Germany and Austria and compared the MagicTouch PTA Sirolimus-Coated-Balloons (SCB) against 7 commercially available Paclitaxel Drug-Coated-Balloons (DCB).
Key Results:
- Primary Patency: SIRONA concluded that a primary patency of 73.8% was achieved by MagicTouch PTA against 75% of Paclitaxel DCBs showing a mere rate difference of 1.2% and meeting the non-inferiority efficacy endpoint of primary patency.
- Favourable Safety Profile: SIRONA demonstrates no significant difference in cdTLR (clinically-driven Target Lesion Revascularization) at 12 months, 92.9% (MagicTouch PTA) and 95.4% (Paclitaxel group).
- Functional Improvements: SIRONA showcased similar improved functional outcomes with both Sirolimus and Paclitaxel groups with a 0.1 difference between them and 89% improving by ≥1 Rutherford stage and many by ≥2 stages.
“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 an 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, who has been supporting and encouraging the RCT, stated after the exciting results. “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.”
“Concept Medical has consistently pursued innovation in vascular therapy. The results of the SIRONA trial advance our mission to offer patient-centric, evidence-based solutions that improve the care and outcomes of those challenged by PAD.” said Dr. Manish Doshi, Founder & Managing Director of Concept Medical.
