Study design <p>Retrospective study.</p> Objectives <p>To evaluate the safety of the Atalante exoskeleton in patients with tetraplegia and high paraplegia.</p> Setting <p>Three inpatient rehabilitation centers in France.</p> Methods <p>Data from thirty-three inpatients with tetraplegia (12 motor complete (American Spinal Injury Association Impairment Scale (AIS) grade A or B), 10 motor incomplete (AIS C or D)) and high paraplegia (at or above T4 level; 10 motor complete and 1 motor incomplete) and an average time since Spinal Cord Injury (SCI) of 2.6 years (19 individuals &lt; 12 months after injury), who completed at least one session of training with the Atalante exoskeleton, were analyzed. The primary outcome was the safety assessment through reported device-related adverse effects (AE). Secondary outcomes included pain (Numeric Pain Rating Scale), spasticity (Ashworth scale), walking ability (WISCI-II), and exoskeleton session data.</p> Results <p>Participants underwent a median of 7.5 (IQR: 3–22.8) exoskeleton training sessions, with a median verticalization duration of 22.4 min (IQR: 18–26.9) and 583.0 steps (IQR: 347.0–854.0) performed. The estimated rate of AEs per session across all sessions was 0.63%, with a 95% confidence interval ranging from −0.56 to 1.81%. One minor AE occurred in one patient, involving hypotension, fatigue and dizziness, leading to session discontinuation. No therapy-related pain or fracture was reported. Regarding secondary outcomes, spasticity remained unchanged while positive changes were observed in WISCI-II scores in 11 patients with incomplete SCI.</p> Conclusions <p>After individual benefit-risk assessment, the Atalante exoskeleton can be safely used in a clinical setting for high SCI patients.</p> Sponsorship <p>Wandercraft</p>