Concept’s MagicTouch PTA SCB Evaluated in Femoropopliteal Disease in 3-Year SIRONA Data

November 3, 2026—Concept Medical announced the presentation of 3-year results from the randomized SIRONA trial of patients with femoropopliteal artery disease treated with percutaneous transluminal angioplasty (PTA) using the company’s MagicTouch PTA sirolimus-coated balloon (SCB).

The SIRONA study’s Principal Investigator, Professor Ulf Teichgräber, MD, presented the data in a late-breaking clinical science session at TCT 2026. Simultaneously, the findings were published by Prof. Teichgräber et al in JACC: Cardiovascular Interventions.

According to Concept Medical, SIRONA is an investigator-initiated, multicenter randomized trial at 25 centers in Germany and Austria. The study included 482 patients with symptomatic femoropopliteal disease (96.3% with intermittent claudication). The patients were randomized 1:1 to SCB or paclitaxel-coated balloon (PCB) angioplasty after successful lesion predilation.

SIRONA previously met its 12-month noninferiority primary endpoints for patency and safety, noted the company.

As summarized in Concept Medical’s press release, the 3-year freedom from clinically driven target lesion revascularization (CD-TLR) was 88.2% with SCB and 80.2% with PCB, an absolute difference of 8.0 points (95% CI, 1.0-14.8; P = .01; hazard ratio [HR], 0.60; 95% CI, 0.36-0.97; log-rank P = .03). Curves separated after year 1.

The company also advised that patient-reported walking distance and quality of life improved in both groups and were sustained through 3 years, with no between-group differences.

Safety outcomes were similar, with an all-cause mortality of 7.4% in both groups (HR, 1.16; 95% CI, 0.59-2.28); major amputation was rare (1 vs 2 patients); and amputation-free survival rates were 92.1% with SCB and 92.2% with PCB. Finally, freedom from clinically driven target vessel revascularization did not differ significantly (83.8% vs 79.1%; P = .27), reported Concept Medical.

The investigators noted that SIRONA was powered for its 12-month endpoints, so the 3-year analyses are exploratory and the CD-TLR finding requires confirmation. Follow-up will continue to 5 years, advised the company.

“Patients in both groups did well; those treated with the SCB needed fewer repeat procedures at the target lesion, with the difference emerging after the first year,” commented Prof. Teichgräber. “Five-year follow-up will tell us whether this benefit holds.”

MagicTouch has received CE Mark approval in Europe. In the United States, it is an investigational device. The FDA has granted Breakthrough Device designation for MagicTouch for the treatment of below-the-knee (BTK) disease, as well as investigational device exemption approvals for both superficial femoral artery and BTK treatment in ongoing trials, stated Concept Medical.