Tampa, Florida, USA, November 3, 2026
Concept Medical Inc. has announced encouraging three-year results from the randomized SIRONA clinical trial, demonstrating a higher rate of freedom from repeat target-lesion revascularization with its MagicTouch PTA sirolimus-coated balloon compared with paclitaxel-coated balloons in patients with femoropopliteal artery disease. The findings were presented as late-breaking clinical science at the TCT 2026 conference and published simultaneously in JACC: Cardiovascular Interventions. The study evaluated the long-term performance of two drug-coated balloon technologies used to treat peripheral artery disease (PAD), a condition involving narrowed or blocked arteries that restrict blood flow to the lower extremities. The results showed that patients treated with the sirolimus-coated balloon were less likely to require another procedure at the originally treated lesion during the three-year follow-up period. However, walking capacity, quality of life and clinical safety outcomes were similar between the treatment groups.
SIRONA Trial Demonstrates Improved Freedom from Repeat Procedures
The SIRONA trial is an investigator-initiated, multicenter randomized study conducted across 25 clinical centers in Germany and Austria. A total of 482 patients with symptomatic femoropopliteal artery disease were enrolled and randomly assigned to receive either sirolimus-coated balloon (SCB) angioplasty or paclitaxel-coated balloon (PCB) angioplasty. Of the participants, approximately 96.3% had intermittent claudication, a condition characterized by leg pain or discomfort during walking because of inadequate blood supply to the muscles. Participants received the MagicTouch PTA sirolimus-coated balloon, developed by Concept Medical, or a commercially available paclitaxel-coated balloon following successful lesion predilation. The study previously achieved its primary non-inferiority endpoints for patency and safety at 12 months. The newly reported three-year analysis provides additional information about the durability of treatment outcomes. At three years, freedom from clinically driven target lesion revascularization (cdTLR) was 88.2% in the sirolimus-coated balloon group, compared with 80.2% in the paclitaxel-coated balloon group. This represented an absolute difference of eight percentage points, with a hazard ratio of 0.60 and a nominal log-rank P-value of 0.03. The findings indicate that fewer patients in the sirolimus group required another clinically driven procedure at the originally treated arterial lesion. The investigators also observed that the difference between treatment groups emerged primarily after the first year. This time-dependent pattern is an important aspect of the long-term findings and requires further evaluation through continued follow-up.
MagicTouch PTA Advances Sirolimus-Coated Balloon Technology
MagicTouch PTA is a drug-coated balloon developed by Concept Medical for peripheral vascular interventions. It uses the company’s proprietary Nanoluté technology to deliver sirolimus, an antiproliferative drug, to the vessel wall during balloon angioplasty. Sirolimus is intended to limit excessive tissue growth that can contribute to recurrent narrowing of the treated artery. Drug-coated balloons combine mechanical vessel expansion with localized drug delivery. Unlike permanent implants, they are designed to deliver the therapeutic agent during the intervention without leaving a drug-eluting stent behind. This approach is particularly relevant in peripheral artery disease, where maintaining blood vessel patency and minimizing repeat procedures are important treatment objectives. Paclitaxel-coated balloons are another established technology used in peripheral vascular interventions. The SIRONA trial provides a randomized comparison between sirolimus-based and paclitaxel-based drug delivery, adding valuable long-term evidence to the field of endovascular treatment. The study found that walking capacity and health-related quality of life improved in both groups, without significant differences between the treatments. Freedom from clinically driven target vessel revascularization was also not significantly different, at 83.8% for sirolimus-coated balloons and 79.1% for paclitaxel-coated balloons.
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Three-Year Safety Outcomes Remain Comparable
The three-year analysis also evaluated mortality, major amputation and other clinical safety outcomes. All-cause mortality was approximately 7.4% in both treatment groups, while major ipsilateral amputations were uncommon, occurring in one patient in the sirolimus group and two patients in the paclitaxel group. Amputation-free survival was 92.1% and 92.2%, respectively. These findings indicate that the two treatment strategies had comparable clinical safety outcomes during the reported follow-up period. The researchers emphasized that the three-year analysis was exploratory because the original SIRONA trial was powered for its 12-month primary endpoints. The long-term target-lesion revascularization difference was not adjusted for multiple comparisons and therefore requires confirmation. Follow-up is expected to continue through five years, providing additional information about long-term treatment durability, patient outcomes and safety. Overall, the SIRONA findings represent an important development in drug-coated balloon technology and peripheral artery disease treatment. The higher three-year freedom from repeat target-lesion procedures observed with MagicTouch PTA provides encouraging evidence for sirolimus-based vascular intervention, while further follow-up and confirmatory research will be necessary to establish the durability and clinical significance of this difference.
Source: Concept Medical press release
