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

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

RenalGuard US Pilot Study (Complete)

A Pilot Study was comducted in four clinical sites in the U.S. with a total of 23 patients enrolled in the study.The Study ws 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).

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