Concept Medical’s MagicTouch PTA in Femoropopliteal Disease Evaluated at 3 Years in SIRONA Trial

April 29, 2026—Concept Medical Inc. announced preliminary 3-year follow-up data from the SIRONA randomized trial comparing the company’s MagicTouch PTA device, a sirolimus-coated balloon for percutaneous transluminal angioplasty (PTA), versus paclitaxel-coated balloon angioplasty in femoropopliteal artery disease.

The SIRONA trial’s Principal Investigator, Professor Ulf Teichgräber, MD, presented the data at the 2026 Charing Cross Symposium.

According to the company, the 3-year analysis showed that the MagicTouch PTA versus the paclitaxel device achieved the following:

• Freedom from clinically driven target lesion revascularization (CD-TLR) was 88.2% versus 80.2% (hazard ratio [HR], 0.6; 95% CI, 0.36-0.97; log-rank P = .03). The results are pending Clinical Events Committee (CEC) adjudication.
• Freedom from all-cause mortality remained comparable between treatment groups (92.6% vs 92.6%; HR, 1.12; P = .67).
• Freedom from major amputation showed no statistically significant difference between groups (99.6% vs 99.6%; HR, 0.54; P = .61).

These preliminary findings suggest that sirolimus-coated balloon angioplasty may provide more durable long-term outcomes than paclitaxel-coated balloon angioplasty, stated the company.

“The preliminary 3-year SIRONA data are very exciting,” commented Prof. Teichgräber in Concept Medical’s press release. “Seeing a sustained reduction in CD-TLR with MagicTouch PTA over such a long follow-up period is highly encouraging and speaks to the durability of sirolimus-based drug delivery in femoropopliteal interventions.”

Prof. Teichgräber continued, “These findings add important long-term randomized evidence to the field and, pending final CEC adjudication, represent a very promising signal for the future role of sirolimus-coated balloons in peripheral artery disease. Importantly, these findings should not be interpreted as a class effect, but rather highlight the need to evaluate individual sirolimus-coated balloon technologies based on robust clinical evidence.”