Concept Medical’s MagicTouch Balloon Shows Low TLR and MALE Rates in Analysis From SirPAD Trial

October 15, 2026—A secondary analysis of the randomized SirPAD trial demonstrated lower rates of target-lesion revascularization (TLR) and major adverse limb events (MALE) at 1 year with the MagicTouch sirolimus-coated balloon (Concept Medical) for percutaneous transluminal angioplasty compared with standard uncoated balloon angioplasty in patients with femoropopliteal peripheral artery disease without tissue loss.

Stefano Barco, MD, presented the findings in a late-breaking trials session at VIVA 2026, the Vascular Interventional Advances conference.

According to the VIVA press release, the multicenter, randomized, blinded-endpoint SirPAD trial assigned patients 1:1 to undergo angioplasty with either a sirolimus-coated balloon or an uncoated balloon. The analysis included 597 patients (median age, 71 years; women, 34.7%). Median target-lesion length was 150 mm, and 53.8% of lesions were total occlusions.

Outcomes at 1 year included TLR, MALE, amputation or TLR, and all-cause mortality.

As summarized in the VIVA press release, the 1-year SirPAD secondary analysis findings included the following findings for the sirolimus-coated balloon group versus the uncoated balloon group, respectively:

• TLR occurred in 17.0% versus 27.1% of patients (absolute risk difference [ARD], –10.1%; 95% CI, –16.6 to –3.4; hazard ratio [HR], 0.58; 95% CI, 0.40-0.82).
• MALEs occurred in 4.1% versus 8.9% of patients (ARD, –4.8%; HR, 0.44; 95% CI, 0.22-0.88).
• The composite outcome of any unplanned amputation or TLR occurred in 17.7% versus 27.1% of patients (ARD, –9.4%; HR, 0.60; 95% CI, 0.42-0.85).
• Target-limb revascularization rates were 19.4% versus 28.4% (HR, 0.63; 95% CI, 0.45-0.89).
• Clinical improvement of at least one Rutherford category occurred in 76.2% versus 70.0% of patients (relative risk, 1.09; 95% CI, 0.99-1.20).
• All-cause mortality was similar between groups, 3.7% versus 5.3% of patients (HR, 0.70; 95% CI, 0.32-1.51).

According to the VIVA summary, these findings were consistent in a more restrictive subgroup of patients with lower disease burden.

The results suggest that sirolimus-coated balloon angioplasty reduces repeat revascularization and improves clinical outcomes compared with uncoated balloon angioplasty in patients with femoropopliteal artery disease without tissue loss, noted the VIVA press release.

In March 2026, the primary results of the SirPAD trial were presented by Professor Barco at ACC.26, the American College of Cardiology’s annual scientific session and simultaneously published by Prof. Barco et al in The New England Journal of Medicine (2026;395:561-570).