First in-human feasibility evaluation of an integrated guidewire Seldinger system with enhanced ultrasound feedback for central venous access

Introduction: Central venous access procedures are among the most frequently performed invasive procedures worldwide, yet they remain associated with measurable complication rates and technical challenges. Despite the widespread adoption of ultrasound guidance, limitations in needle visualization, needle stability and workflow inefficiencies persist. Methods: This study presents the first in-human feasibility evaluation of an integrated guidewire Seldinger-based central venous access system with enhanced echogenic feedback. Three experienced physicians performed central venous access on forty patients using the Seldinger-based 510k-approved Primero device vascular access system under ultrasound guidance. Results: The device demonstrated a procedural success rate of 97.5%, a successful first attempt placement rate of 95%, and a median time from skin puncture to guidewire placement of 103.5 s. Physicians reported qualitatively improved visualization, ease of use, enhanced control, and reduced hand transitions, which improved workflow during vascular access. Conclusions: These findings support feasibility and justify further controlled prospective evaluation.