Initial Clinical Experience with the CLEANERTM Plus Thrombectomy System for Acute and Chronic Deep Vein Thrombosis: A Case Series

AbstractBackground: Deep vein thrombosis (DVT) poses a significant public health burden, with potential long-term compli- cations such as post-thrombotic syndrome (PTS). Mechanical thrombectomy devices, including those integrating mac- eration and aspiration, aim to rapidly reduce thrombus burden while minimizing systemic thrombolytic exposure. The CLEANERTM Plus Thrombectomy System (Argon Medical Devices) is a novel 18F, 115-cm aspiration catheter with an integrated 0.035-inch rotational sinusoidal maceration wire (4000 rpm, 15-mm amplitude) and vacuum aspiration (max- imum 28 inHg via a 400-cc canister), controlled via a handpiece allowing independent or simultaneous operation. This system is indicated for mechanical thrombectomy, aspiration, and selective infusion in peripheral venous vasculature Objective: To report detailed initial clinical outcomes, including efficacy in thrombus reduction, safety metrics, and usability, in a series of patients with acute and acute-on-chronic DVT, emphasizing performance in complex chronic thrombi.Design, Setting, and Participants: Retrospective case series of 5 consecutive patients treated between April 3, 2025, and July 14, 2025, at 4 US centers (IU Health Methodist Hospital, Lakeland Regional Health Medical Center, and Baylor Scott & White, The Heart Hospital Plano). Patients included adults with symptomatic lower extremity DVT confirmed by imaging.Intervention: Percutaneous venous thrombectomy using the CLEANER Plus system, with adjunctive balloon angio- plasty, stenting, utilizing intravascular ultrasound (IVUS), under fluoroscopic guidance when indicated.Main Outcomes and Measures: Primary efficacy: Percentage thrombus burden reduction (assessed via fluoroscopy or IVUS, graded as >75%, 50%-75%, or <50%). Safety: Estimated blood loss (EBL), procedure duration, adverse events (e.g., pulmonary embolism [PE], bleeding), hemodynamic instability, and transfusions. Secondary: Device usability, complications, and physician feedback on comparative performance.Results: Patients (3 female; mean age, 69.6 years [range, 33-83]) predominantly presented with acute-on-chronic il- iofemoral DVT (80%), including those with prior stents or IVC filters. Access was via internal jugular (40%) or popliteal (60%) with 18-22F sheaths. Mean procedure duration was 84 minutes (range, 65-105); mean EBL, 483 mL (range, 325- 850), with no instability or transfusions. Thrombus reduction exceeded 75% in most vessels across 80% of cases, with complete flow restoration in all, even in chronic organized thrombi. No device-related adverse events. Physicians noted superior or comparable performance to alternatives in 80%, particularly for chronic thrombus components.Conclusions and Relevance: The CLEANER Plus system achieved high thrombus clearance rates (>75% in 80% of cases) with acceptable safety in complex DVT, demonstrating particular success in acute-on-chronic thrombi resistant to aspiration-alone approaches. Larger prospective studies are needed to confirm these findings.Keywords: Thrombectomy, DVT, VTE, Rotational, Cleaner, Post Thrombotic Syndrome