Abstract WP41: The NeVa Thrombectomy Device: Initial Clinical Experience

Abstract

Introduction: The NeVa (Vesalio) thrombectomy device is a CE approved novel hybrid-cell stent retriever with offset enlarged openings coupled with enhanced expansive radial force and a closed distal end. The device was designed to incorporate and trap resistant emboli inside the device. Materials and Methods: Prospective data was collected on the first thirty consecutive patients treated at four stroke centers in two countries with NeVa as first line treatment. Clinical outcome measures included re-perfusion scores after each NeVa pass, device and procedure related complications, 24 hour NIHSS, mRS at discharge and 90 days. Results: The mean presenting NIHSS was 16 (IQR 13-20) with mean time from stroke onset of 5.45 hours. Sites of primary occlusion were 10 ICA, 16 M1-MCA, 3 M2-MCA and one basilar. There were five tandem occlusions that required extracranial treatment. Reperfusion outcomes after each NeVa pass; TICI >/= 2b after first pass 63%(19/30), after 1 or 2 passes 83% (25/30), after 1 to 3 passes 90% (27/30). TICI 2c-3 after first pass 47% (14/30), after 1 to 2 passes 57% (17/30), after 1 to 3 passes 60% (18/30). TICI >/= 2b after final NeVa pass 93% (28/30). TICI 2c-3 after final NeVa pass 63% (19/30). There were no device related SAEs and no sICH. Clot material was partially or completely incorporated into the inside of the device after 28 of 40 (70%) passes. The mean 24 hour NIHSS was 7 (IQR 1-11) and the discharge mRS was 0-2 in 40% (12/30) of patients. The 90 day mRS follow up will be completed late August. Conclusions: The NeVa device demonstrated a high rate of first pass complete reperfusion effect and a good safety profile in this initial clinical experience.