Concept Medical Inc.a global leader in innovative drug delivery technologies, is proud to report positive results from the SIRONA-Studie (Head-to-Head Comparison of SIROSludge versus Paclitaxel Drug-Eluting BallooTHATngioplasty in the Femoropopliteal Artery RCT showing that Sirolimus-Coated Balloons (SCB) (MagicTouch-PTA) provide patency and functional benefits comparable to those of paclitaxel-coated balloons in patients with peripheral artery disease (PAD). The first year data 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 results and highlighted sirolimus-based therapy as a viable new option in femoropopliteal procedures.
The prospective, multicenter, core laboratory-reviewed RCT included a total of 482 patients at 25 sites in Germany and Austria and compared the MagicTouch PTA sirolimus-coated balloon with seven commercially available paclitaxel-coated balloons.
Key results
· Primary patency: SIRONA concluded that a primary patency of 73.8% was achieved with MagicTouch PTA versus 75% with 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 cdTLR (clinically-driven target lesion revascularization) at 12 months at 92.9% (MagicTouch PTA) and 95.4% (paclitaxel group).
· Functional improvements: SIRONA demonstrated similar improved functional outcomes in both the sirolimus and paclitaxel groups with a difference of 0.1 between them and an 89% improvement 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 “leave nothing behind” principle. However, safety concerns remain, so recent evidence has encouraged the exploration of sirolimus as an alternative drug option Support treatment of peripheral arterial disease Since the SIRONA RCT has shown that sirolimus is as effective as paclitaxel Doctors may soon have additional personalized approaches available to address the diverse needs of patients with peripheral arterial disease,” says Prof. Ulf Teichgräber.
After the exciting results, Prof. Dierk Scheinert, who supported and promoted the RCT, stated: “After several positive signals from preclinical studies and smaller single-arm studies with sirolimus-coated DCBs, the results of the SIRONA RCT with the head-to-head “The randomization design represents the first level 1 evidence of clinical efficacy of the Magic Touch sirolimus-coated DCB for a broad spectrum of femoropoliteal obstructions.”
“Concept Medical has consistently driven innovation in vascular therapy,” said Dr. Manish Doshi, founder and executive director of Concept Medical. “The results of the SIRONA study bring us closer to our goal of providing patient-centered, evidence-based solutions that improve care and outcomes for people with peripheral artery disease.”
Information about Concept Medical
Headquartered in Tampa, Florida, Concept Medical is a global leader in advanced drug delivery platforms. The flagship MagicTouch Sirolimus Coated Balloon (SCB) has reshaped the landscape of coronary and peripheral interventions, reaching more than one million patients worldwide. Through continued investment in rigorous clinical research ー an example of this is the SIRONA study ー Concept Medical remains at the forefront of developing next-generation vascular therapies.
Further information about the SIRONA study or Concept Medical’s innovative device portfolio can be found at www.conceptmedical.com
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