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