First-in-human evaluation of a novel subcutaneous intraosseous vascular access device for outpatient infusions

Abstract

Background:

Conventional intraosseous (IO) access is typically reserved for emergency situations and limited to short-term use (⩽48 h). We introduce a novel, fully subcutaneous IO device designed to provide stable, longer-term vascular access in non-emergent settings. This device may benefit patients requiring intravenous therapies with challenging venous access or chronic kidney disease (CKD) who need to preserve peripheral and central veins for future arteriovenous fistula creation for hemodialysis.

Aim and methods:

This prospective, single-arm, first-in-human study evaluated the feasibility and safety of the fully subcutaneous IO device over a 7-day implant with daily infusions in patients with challenging venous access or CKD. Patency was assessed radiographically after placement, clinically during infusion visits, and either radiographically or clinically before explant. Usability and tolerability were evaluated through clinician and patient surveys. Safety was assessed by monitoring device-related adverse events for 30 days after explant.

Results:

Ten patients were successfully implanted with the device, and patency was maintained for a full 7-day duration without routine maintenance. Clinicians reported easy device implant, use, and explant. Three patients experienced pain during the first medullary infusion; one had additional pain during the second and third infusions. No patient discomfort was reported after day three. No adverse device effects (ADEs) occurred during the study or follow-up.

Conclusion:

This novel, fully subcutaneous IO device appears to be a feasible, usable, and safe option for short-term infusion therapy in patients with CKD or challenging venous access. These findings support further investigation into its use as a long-term intraosseous vascular access option.