The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners
Are between 18 and 80 years of age and Care Partner is at least 18 years of age at the time of signing consent.
Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Screening Period
Have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min prior to the end of Screening
Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period.
Hgb level of < 9 g/dL at Screening
Persistent pre-dialysis sitting SBP < 100 mmHg despite medical therapy,
Nadir intradialytic Systolic Blood Pressure (SBP) < 90 mmHg, if Subject's pre-HD SBP < 160 mmHg
Nadir intradialytic SBP < 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg