News | December 08, 2008

PLC Systems Receives FDA Approval for Study of RenalGuard

December 9, 2008 - PLC Systems Inc. said recently it has received full approval from the FDA for its U.S. pivotal trial to study the effectiveness of the its RenalGuard System and associated therapy in the prevention of Contrast-Induced Nephropathy (CIN).

The FDA also approved PLC's request to expand their investigation from the 246 patients conditionally approved earlier this year to 406 patients and eliminate the requirement for an interim study analysis to be performed. As a result of this and other changes, the study is no longer considered an adaptive study.

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 company’s 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 a randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial will now include 406 patients.

Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. CIN is the third most common cause of in-hospital acute renal failure. 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.

For more information: www.plcmed.com

Related Content

GlobalData, contrast media injectors market,
News | Contrast Media Injectors | May 03, 2016
The global market for contrast media injectors is set to increase from $830 million in 2015 to almost $1.8 billion by...
Galt Medical, Health Line International Corp., Nexus CT Midline Catheter with MST Insertion Kit

Image courtesy of Galt Medical

Technology | Contrast Media Injectors | October 01, 2015
Galt Medical has partnered with Health Line International Corp. and launched the Nexus CT Midline Catheter with MST...
Contrast media injectors. angiography contrast injectors

The Bayer Arterion contrast injector.

Feature | Contrast Media Injectors | February 10, 2015 | Raissa Rocha and Dave Fornell
There have been several recent advances with contrast media injector technology, including cutting costs by reducing...
contrast media injectors, angiographic contrast injector

Medrads Avanta injection system offers fixed or variable flow contrast and saline delivery on demand, replacing the manual manifold and syringe in the cath lab.

Feature | Contrast Media Injectors | July 08, 2010 | Dave Fornell
Automated contrast media injectors are used in cardiac imaging to help improve patient safety and enhance image quality...
Overlay Init