Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients

Inclusion Criteria:

- Male or non-pregnant female equal or greater than the age of 18 years old and is able
to provide informed consent.

- Subject is scheduled to undergo an elective catheterization procedure

- Hemodynamically stable

- At increased risk of developing CIN

- Subject has agreed to all follow-up testing.

Exclusion Criteria:

- Class 4 Congestive Heart Failure (CHF)or a documented left ventricular ejection
fraction < 30%

- Is anuric or has undergone renal replacement therapy within the past month, or has a
known inability to have a Foley catheter placed.

- Subject has been hospitalized or treated medically for any change in renal function
over the past week (i.e. dialysis, etc.), or a significant change in renal function is
noted at time of screening.

- Has documented severe Aortic Stenosis.(Note: Subjects who have undergone successful
replacement or repair of their aortic valve are not excluded.)

- Currently has a known clinically significant electrolyte imbalance or clinically
significant arrhythmias which compromise subject's hemodynamic state.

- Patient has severe anemia (hemoglobin < 8.0 g/dL) at screening

- Has received contrast within 10 days of procedure or has a planned additional cardiac
or renal or other major surgical procedure within the 7 day follow-up period.

- Has ruled in for a Serious Heart Attack within 48 hours of the planned procedure

- Has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90%
on room air assessed on day of procedure.

- Planned addition, discontinuation or dose adjustment of nephrotoxic drugs

- Subject has a known hypersensitivity to furosemide and/or the contrast agent being
used.

- Subject is currently, plans, or has been enrolled in another clinical study involving
use of an investigational drug or device within the prior 30 days.

- Subject is pregnant or breastfeeding.

- Subject is unable to provide informed consent.