RenalGuard Clinical Investigations are conducted using RenalGuard Therapy® and RenalGuard System™.

For more information, please contact ClinicalInvestigations@plcmed.com.

MYTHOS

MYTHOS is an investigator-sponsored, randomized clinical trial designed to evaluate the effectiveness of RenalGuard Therapy® at reducing the incidence of Contrast-Induced Nephropathy (CIN). The study compares the rates of CIN in at-risk patient who receive induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to patients who receive standard overnight hydration. All of the patients enrolled in the study have been scheduled for cardiac catheterization and PCI and are already at increased risk of developing CIN due to reduced renal function. The trial anticipates enrolling a total of 120 patients, and is expected to be completed in 2009.

Preliminary results were presented August 31, 2009 at ESC and in September 2009 at TCT. Updated results, based on 105 patients, were presented in November 2009 at the American Heart Association conference. The control group had a 14% incidence of contrast-induced nephropathy (CIN), whereas only 4% of those who were treated with RenalGuard acquired CIN (P=0.08). Dr. Marenzi also reported that the incidence of in-hospital complications in the control group was 18%, while only 6% in the RenalGuard group, a statistically significant difference (p=0.05)

RenalGuard US Pilot Study (Complete)

A Pilot Study was conducted in four clinical sites in the U.S. with a total of 23 patients enrolled in the study. The Study was designed to evaluate the safety of RenalGuard System and RenalGuard Therapy, under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA). The results were presented at the American College of Cardiology, March 2009.

RenalGuard Pivotal Study

PLC Medical Systems has received FDA conditional approval for an Investigational Device Exemption (IDE) to begin the pivotal trial for RenalGuard Therapy. The trial is designed as a multi-center, prospective, randomized study to evaluate the effectiveness and safety of RenalGuard in the prevention of Contrast-Induced Nephropathy (CIN) during procedures performed in a catheterization lab.

Clinical Investigations are planned to establish the safety and effectiveness of RenalGuard Therapy in reducing the incidence of Contrast-Induced Nephropathy (CIN) in high-risk patients. RenalGuard System is not intended for the infusion of blood, blood components, medications, or nutritional fluids, nor have any investigations been carried out on patients with congestive heart failure (CHF) or acute cardiac instability.

Educational Resources
RenalGuard Resources