PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System

This is a prospective, open label, single arm, non-randomized, multicentric first in human clinical trial of the PortIO device for intraosseous infusion of fluids and/or medications for up to 60 days in subjects that meet the inclusion criteria. Both hospitalized patients as well as outpatients can be screened and, if appropriate, can be consented and enrolled into the study. They will have the PortIO device implanted by a qualified physician and then undergo prescribed infusions as needed and determined by the treating physician over either a 7-day or a 60-day period. The device will then be removed after the 7 days or 60 days of use and the subject followed up at 30 days after explant.