The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center
by trained individuals and In-Home by trained Subjects.
- Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis
achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by
his/her treating nephrologist.
- Subject has a well-functioning and stable vascular access that allows a blood flow of
at least 300 ml/min.
- Life expectancy less than 12 months from first study procedure.
- Subject has had a recent major cardiovascular adverse event within the last 3 months.
- Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction
less than 30%.
- Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
- Subject has uncontrolled blood pressure.
- Subject is intolerant to heparin.
- Subject is seroreactive for Hepatitis B Surface Antigen.
- Subject has an active, life-threatening, rheumatologic disease.
- Subject has a history of adverse reactions to dialyzer membrane material.
- Subject is expected to receive an organ transplant during the course of the study.
- Subject has a life-threatening malignancy actively receiving treatment that would
prevent successful completion of the study protocol.