Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Inclusion Criteria:

To be eligible for participation in this study, an individual must meet all the following criteria:

1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG)and/or valvular surgery

2. Male or Female age 22 to 85 years

3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2

4. Signed and dated informed consent

5. Female patients of childbearing potential must:

6. have negative pregnancy test at the informed consent visit,

7. be using previously initiated approved and effective contraception from theinformed consent visit through completion of the study *The only recommendedcontraception is condoms.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Any individual, or their legally authorized representative (LAR), who does notunderstand the requests and risks of participating in the clinical trial or isunable to give informed consent

2. Pregnancy or lactation

3. Prior cardiac surgery within the last 6 months

4. Hemodynamic instability as determined by the Principal Investigator

5. Immunosuppression

6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis)

7. History of polycystic kidney disease

8. Patients with only one active kidney or one poorly functioning kidney

9. Evidence of current kidney obstruction (e.g., Kidney stones)

10. Evidence of current hydronephrosis

11. Active upper and/or lower urinary tract infections

12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment

13. Ongoing sepsis or endocarditis

14. Patients who have an expected 30-day postoperative mortality greater than 10% asdetermined by the Principal Investigator

15. Any secondary condition as determined by the investigator that would place thesubject at an increased risk or preclude the subject's full compliance with thestudy procedures, including injuries to the urinary organs and/or external genitals;or severe BPH

16. Unexplained/unexpected gross hematuria as determined by the Investigator

17. Current or planned treatment with an investigational drug (IND), device (IDE), orother investigational intervention within 3 months prior to or during participationin this clinical trial

18. Patients who have a current unrepaired ureteral avulsion as determined by theinvestigator

19. Patients otherwise contraindicated for urological interventions, including ureterguidewire placement via bladder cystoscopy and ureteral catheterization, orotherwise contraindicated for any of the other study procedures