Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon as a Promising Alternative for PAD Treatment

Concept Medical Inc., a global leader in innovative drug-delivery technology, proudly reports positive outcomes from the SIRONA (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery) RCT, which show that its sirolimus-coated balloons (SCB) (MagicTouch -PTA) provide patency and functional benefits on par with paclitaxel-coated balloons 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.

Sirolimus-Coated Balloon (MagicTouch PTA) as a Promising Alternative for PAD Treatment

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-balloon against 7 commercially available paclitaxel-coated-balloons.

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.

• Favorable 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 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," said Dr. Manish Doshi, Founder & Managing Director of Concept Medical. "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."

About Concept Medical

Headquartered in Tampa, Florida, Concept Medical is a world leader in cutting-edge drug-delivery platforms. Its flagship MagicTouch Sirolimus Coated Balloon (SCB) has reshaped the landscape of coronary and peripheral interventions, reaching more than a million patients globally by continuously investing in rigorous clinical research—exemplified by the SIRONA trial—Concept Medical remains at the forefront of developing next-generation vascular therapies.