Treating Calcified Above- and Below-the-Knee Arteries with a Focused Force PTA Balloon: Results from the UltraScore Post-Market, Real-World Study

Objective: To assess the clinical use of the UltraScore balloon in a real-world setting. Methods: This is a prospective, multicenter, single-arm, real-world study to assess the clinical use of the UltraScore balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal and below-the-knee (BTK) arteries. A total of 350 subjects were treated with the study device and follow-up was performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure. The primary endpoints were technical success and optimal PTA, defined as ≤30% residual stenosis without major flow-limiting dissection. Secondary endpoints included rate of bail-out stenting, freedom from target lesion revascularization (TLR), freedom from major amputation and clinical improvement measurements. Results: Technical success was 100% and optimal PTA was 72.8%. The rate of bail-out stenting was 4.0%; freedom from TLR was 100% at 30 days, 93.5% at 6 months and 88.2% at 12 months. Freedom from major amputation was 97.4% at 30 days, 94.7% at 6 months and 93.4% at 12 months. Conclusions: This study supports the feasibility and potential clinical utility of the UltraScore balloon when used during the endovascular treatment of stenotic and calcified lesions in the SFA, popliteal and BTK arteries.