UltraScore: Final Results of a Multi-Center Study

During a session at the first day of LINC 2022 that focused on novel approaches and insights for treatment of complex femoropopliteal disease, Dr. Robert Beasley, from Palm Vascular Centers in Miami Beach, Florida, spoke to attendees about the results of a study on the UltraScore device (BD), a semicompliant balloon. The prospective, multi-center, single-arm, nonrandomized study was conducted to assess the clinical use of the UltraScore balloon in a real-world, on-label, clinical application. Thirty sites enrolled subjects; 350 were treated with the study device (176 femoropopliteal; 174 infrapopliteal).

After 12 months, the primary endpoint of procedural success (less than or equal to 30% residual stenosis, without major flow-limiting dissection, was 62.3% in the femoropopliteal group. “The reason for the lower number is that the core lab stated that there was a greater than 30% stenosis after the second inflation in over a quarter of the patients they looked at and 15% had a major flow-limiting dissection,” Dr. Beasley explained. Procedural success for the infrapopliteal group was 83.3%, and procedural success for the full cohort was 72.8%. Technical success was 100% for both cohorts.

In summary, primary patency was 77.9% (Kaplan Meier) for the femoropopliteal cohort; freedom from TLR (Kaplan Meier) was 89.8%; freedom from major amputation at 12 months (Kaplan Meier) was 94.6%; the rate of bailout stenting after the UltraScore balloon for the full cohort was 4.0%; and an overall improvement was seen in both ankle-brachial index and Rutherford class.