Dealing With Calcium: A Case Report

Purpose: We report the 24-month outcomes of the PROMISE I early US feasibility study (EFS) after treatment of no-option chronic limb-threatening ischemia (CLTI) with Transcatheter Arterialization of Deep Veins (TADV) using the LimFlow System.

Materials and Methods: There were 32 patients with no-option CLTI who were enrolled in this single-arm EFS of the LimFlow TADV System. Following TADV treatment using the LimFlow System, patients were assessed for clinical status and pain, wound healing status, and duplex ultrasound at 30 days and 6 months post treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 months. Secondary endpoints evaluated included technical success of the procedure, wound healing, and secondary patency at 6 months.

Results: Of 32 enrolled patients, 31 were successfully treated with the LimFlow System at the time of the procedure. The 30-day and 6-month, 12-month, and 24-month AFS rates were 91%, 74%, 70%, and 59%, respectively. The 30-day and 6-month, 12-month, and 24-month limb salvage rates were 91%, 77%, 77%, and 77%, respectively. There were no amputations after day 75. Wound healing status of fully healed or healing was 92% at 24 months.

Conclusions: The LimFlow TADV System was effective in treating no-option CLTI with a high technical success rate, resulting in a significant percentage of patients treated surviving free of major amputation at 24 months. These results, combined with a high percentage of patients with full or partial wound healing, suggests the LimFlow System is safe and technically feasible.