News | March 20, 2008

FDA Gives Green Light to RenalGuard Study for CIN Prevention

March 21, 2008 - The FDA gave conditional approval to PLC Systems to begin enrollment in a U.S. pivotal trial to study the effectiveness of RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy (CIN).

RenalGuard is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.

RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys. The real-time measurement and matched fluid replacement design of the RenalGuard System is intended to ensure that a high urine flow is maintained before, during and after these procedures. This should allow the body to rapidly eliminate contrast, reducing its toxic effects. The RenalGuard System, with its matched fluid replacement capability, is intended to minimize the risk of over- or under-hydration.

The FDA’s conditional approval to the Investigational Device Exemption (IDE) supplement will enable the company to commence its pivotal study this spring focused on incorporating FDA’s input into our final study protocol.

Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre- existing renal impairment - all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. The U.S. pivotal study, under the supervision of principal investigators Charles Davidson, M.D., professor of Medicine, Northwestern University Medical School and Richard J. Solomon, M.D., professor of Medicine, University of Vermont College of Medicine, is designed as an adaptive, randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial is expected to last through 2009 and will include a minimum of 246 patients.

Studies indicate that approximately 15-20 percent of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN. The estimated mortality rate for patients that acquire CIN may be as high as 35 percent.

For more information: www.plcmed.com

Related Content

Imaging agent helps predict success of lung cancer therapy
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – Doctors contemplating the best therapy for...
OptiStar Elite injector
Feature | Contrast Media Injectors | March 07, 2018 | Grand View Research Inc.
The global contrast media injectors market is expected to reach $1.4 billion by 2025, growing at a compound annual...
TriHealth in Cincinnati

TriHealth in Cincinnati.

Sponsored Content | Case Study | Contrast Media Injectors | March 06, 2018
The continuing search for advantages to improve workflow has radiology departments constantly searching for new...
Guerbet Presents Contrast&Care Injection Management Solution at ECR 2018
News | Contrast Media | February 28, 2018
February 28, 2018 — Guerbet will present its new Contrast&Care application, as well as other...
A brain MRI. Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns. Gadolinium deposition in the brain has raised concerns about Gadolinium toxicity.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Feature | Magnetic Resonance Imaging (MRI) | February 16, 2018 | Dave Fornell
One of the biggest concerns in radiology in recent years is the safety of gadolinium-based contrast agents (GBCAs) us
ACR Introduces New Contrast Reaction Card
News | Contrast Media | February 07, 2018
The American College of Radiology (ACR) introduced a new contrast reaction card that summarizes important steps to be...
Bracco Diagnostics' MultiHance Contrast Agent Earns Expanded Approval for Pediatric MRI
News | Contrast Media | January 30, 2018
Bracco Diagnostics Inc. announced the labeling of its contrast agent MultiHance has obtained U.S. Food and Drug...
Study Finds No Evidence that Gadolinium Causes Neurologic Harm

MR images through, A, C, E, basal ganglia and, B, D, F, posterior fossa at level of dentate nucleus. Images are shown for, A, B, control group patient 4, and the, C, D, first and, E, F, last examinations performed in contrast group patient 13. Regions of interest used in quantification of signal intensity are shown as dashed lines for globus pallidus (green), thalamus (blue), dentate nucleus (yellow), and pons (red).

News | Contrast Media | January 11, 2018
January 11, 2018 — There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive dec
Male Triathletes May Be Putting Their Heart Health at Risk
News | Cardiac Imaging | January 09, 2018
Competitive male triathletes face a higher risk of a potentially harmful heart condition called myocardial fibrosis,...
Overlay Init