Safety and Clinical Performance of Peripherics™ Paclitaxel-Coated Balloon Catheter in Below-the-Knee Arteries: A Multicenter Post-market Study.

INTRODUCTION: Below-the-knee (BTK) arterial disease is associated with a high risk of limb loss, yet evidence supporting the use of paclitaxel-coated balloons (PCB) in routine clinical practice remains limited. AIM: This study aimed to evaluate the safety and clinical performance of Peripherics™ PCB catheter (Sahajanand Medical Technologies Limited, Surat, India) in the treatment of BTK arteries during routine clinical practice. METHODS: This retrospective, observational, multicenter, single-arm, investigator-initiated, post-market study was conducted between September 2022 and September 2024 at four centers in India. All consecutive patients aged ≥18 years with Rutherford categories III-V, having de novo or non-stented restenotic lesions in one or two native arteries (below the tibial plateau and above the tibiotalar joint), and treated with at least one Peripherics™ PCB catheter were included. The primary safety endpoint was 30-day major adverse limb events (MALE) and perioperative all-cause death (POD). MALE comprised above-ankle amputation or major reintervention involving a BTK artery. RESULTS: A total of 71 Peripherics™ PCB catheters were used in 70 patients (mean age: 63.3±11.9 years; n=58; 82.9% male) to treat 70 lesions in BTK arteries. Rutherford class V was observed in the majority of patients (n=44; 62.9%). Thrombus was present in 39 (55.7%) lesions, total occlusion in 25 (35.7%), and calcification in 28 (40%) lesions. Device success, technical success, and procedural success were 100% (n=71), 100% (n=70), and 97.1% (n=68), respectively. The mean ankle-brachial index improved from 0.51±0.15 at baseline to 0.79±0.16 at 30 days. At 30 days, the MALE with POD was observed in two (2.9%) patients, including one patient who required thrombolysis followed by major reintervention (1.4%) and one perioperative death (1.4%). Clinical improvement was evident in 60 (87%) patients who demonstrated improvement in at least one Rutherford class. CONCLUSION: The Peripherics™ PCB catheter demonstrated favorable safety and clinical performance in the treatment of BTK arteries, with low event rates and marked clinical improvement at 30 days.