Gujarat: Concept Medical Announces Successful SIRONA Trial Results, Demonstrating Sirolimus-Coated Balloon As Promising Alternative For PAD Treatment

Concept Medical Inc., a global leader in innovative drug-delivery technology having its state-of-the-art manufacturing facility in Surat has revealed  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 below-the-knee 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-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 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.

Statement Of Prof. Ulf Teichgräber

“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.

“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.”