Florida based new drug delivery technology company, Concept Medical Inc., based in Florida, has announced positive results from the SIRONA trial. To treat femoropopliteal artery disease, this was the first direct test of sirolimus-coated balloons (SCB) and paclitaxel drug-coated balloons (DCB). The results show that MagicTouch PTA Sirolimus-Coated Balloons (SCB) work just as well and have the same patency as paclitaxel-coated devices. This could mean that doctors can give patients with peripheral arterial disease (PAD) a safer option. 

Prof. Ulf Teichgräber, Principal Investigator, presented the trial's one-year data during the Late-Breaking Clinical Trials Session at the TCT USA 2024 conference. TCTMD's coverage underscored the relevance of these findings, emphasising the possibility that sirolimus-based medicines could play a larger role in femoropopliteal interventions.

SIRONA, a prospective multicenter, core lab-adjudicated randomised controlled trial (RCT), included 482 participants from 25 sites in Germany and Austria. The experiment aimed to directly compare the MagicTouch PTA SCB to seven widely available paclitaxel-coated balloons. SIRONA uses a head-to-head randomisation strategy to offer strong clinical evidence for the efficacy of sirolimus-coated balloons. 

It was found that MagicTouch PTA SCB had a primary patency rate of 73.8%, which was about the same as the 75% rate seen with balloons coated with paclitaxel. The small difference of 1.2% met the non-inferiority criterion, showing that sirolimus-coated devices work just as well at keeping arteries open. This finding is important because it shows that sirolimus-based therapy can work instead of the more common paclitaxel-based options. 

Aside from efficacy, the safety profile of MagicTouch PTA SCB was a key highlight of the experiment. The study didn't find any big differences between the two groups in the rates of clinically driven target lesion revascularisation (cdTLR). At the 12-month mark, the cdTLR rate was 92.9% for the sirolimus group and 95.4% for the paclitaxel group. The sirolimus-coated balloon is safe and reliable in clinical settings, as shown by this small change in the rate of revascularisation. 

The functional outcomes of sirolimus and paclitaxel-coated balloons were about the same, which supports the case for therapy based on sirolimus. Approximately 89% of patients in both groups improved by at least one Rutherford stage, with many improving by two or more. These functional gains demonstrate not just the treatments' equivalent clinical performance but also their positive influence on patient quality of life. 

Prof. Ulf Teichgräber stressed the trial's significance, saying, "Historically, paclitaxel-coated balloon angioplasty has been the standard of care for PAD, particularly in the femoropopliteal segment." However, worries about paclitaxel's safety have led to the investigation of alternate pharmacological choices. With SIRONA confirming that sirolimus is equally effective, we may now provide more personalised treatment options for PAD patients." 

Prof. Dierk Scheinert, a recognised expert who played an important role in conducting the trial, stated, "The results of SIRONA represent the first level of evidence confirming the clinical efficacy of sirolimus-coated DCBs for a broad range of femoropopliteal obstructions." This head-to-head randomisation method provides persuasive evidence that sirolimus-coated devices are an effective therapeutic alternative." 

Dr. Manish Doshi, Concept Medical's founder and managing director, is optimistic about the trial's future implications. "Concept Medical has long valued innovation in vascular therapy. The SIRONA trial results are a key milestone in our mission to create patient-centred, evidence-based solutions. These findings will surely improve PAD care and provide new hope to patients worldwide. 

The SIRONA trial's favourable results may stimulate widespread use of sirolimus-coated balloons in clinical practice, answering long-term concerns about paclitaxel's safety. Medics are looking for safer and more effective ways to treat femoropopliteal pain, and sirolimus-based devices like the MagicTouch PTA SCB may become the best option.