VIVA 2026: New Data Shifts Standards in Vascular Intervention

The SELUTION4SFA trial, the first U.S. randomized study for a sirolimus-eluting balloon, reported that the SELUTION SLR™ device achieved 78.6% primary patency at 12 months, outperforming standard plain balloon angioplasty. Complementing this, secondary analysis of the SirPAD trial confirmed that sirolimus-coated balloons reduced target-lesion revascularization to 17% at one year, compared to 27.1% with uncoated alternatives. These findings suggest a shift toward sustained drug-release platforms to manage femoropopliteal lesions.

Beyond mechanical interventions, pharmacological innovation showed promise. A double-blinded study on the drug montelukast demonstrated a significant reduction in major adverse limb events among patients undergoing endovascular treatment. By inhibiting leukotriene-mediated inflammation, the therapy achieved an 84% primary patency rate at 12 months. Meanwhile, the PROMISE III trial provided critical evidence for the LimFlow System in "no-option" patients, showing an 84.1% limb salvage rate at one year for those with chronic limb-threatening ischemia, offering a vital alternative for patients facing amputation.