Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients

Exclusion Criteria

• •1. Subject is a pregnant or nursing (lactating) woman, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
• •2. History or presence of conditions which, in the judgment of the investigator, are known to interfere with the distribution, metabolism, or excretion of drugs
• •3. History or presence of conditions that may place the subject/patient at increased risk as determined by the investigator.
• •4. History of surgery or major trauma within 12 weeks of screening or surgery planned within 4 weeks of the study, including during study participation.
• •5. Has taken other investigational drugs within 30 days or 5 half-lives of the investigational drug's PK, PD, or biological activity, whichever is longer, prior to first dose of VFI in this study.
• •6. Prior exposure to VFI or known allergy or hypersensitivity to dextran, 5-aminofluorescein dye, or 2-sulfohexamine rhodamine dye.
• •7. History of any clinically significant allergic or negative reactions, side effects, or anaphylaxis to iodine, dyes, shellfish, isotopes, or dextran molecules.
• •8. Significant blood loss (\> 450 mL) or has donated 1 or more units of blood or plasma within 4 weeks prior to study participation.
• •9. Presence of significant hemodynamic instabilities defined as systolic BP \<100 on dialysis requiring saline infusion in the past 4 weeks.
• •10. Presence of ascites and/or 4+ anasarca.
• •11. Any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
• •12. Involved in the planning or conduct of this study.
• •13. Unwilling or unlikely to comply with the requirements of the study.
• •14. Clinically significant ongoing bleeding, changing hemoglobin, or experienced significant blood loss within the last 4 weeks.
• •15. Had a PRBC transfusion in the prior 2 weeks
• •16. Use of midodrine.
• •17. Any other condition or prior therapy that, in the investigator's opinion, is likely to deteriorate during study participation
• •18. Subjects suffering from significant non-cardiac diseases of other organ systems (e. g. Malignancies, significant neurological diseases).
• •19. Subject has a psychiatric disease or a history of illicit drug use that would prohibit them from complying with study requirements.
• •20. Use of hemodialysis catheter as primary vascular access for hemodialysis