PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) I...(led trial at up to 30 sites inthe U.S. E...),Health
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PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) In the U.S.
Date:3/20/2008
led 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.
Contrast-Induced Nephropathy
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. It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and the risk of having to undergo renal dialysis therapy. Any of these can result in prolonged hospital stays and increased medical costs. Studies indicate that approximately 15-20% 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%.
About RenalGuard
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.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in
innovative technologies for the cardiac and vascular markets. Headquartered
in Franklin, Mass., PLC pioneered the CO2 Heart Laser System, which cardiac
surgeons use to perform CO2 transmyocardial revascularization (TMR) to
alleviate symptoms of severe angina. CO2 TMR offers a treatment option for
angina patients who suffer from severe coronary artery disease. The CO2
Heart Laser is the world's first TMR angina relief device cleared for
commercial distribution by both the U.S. Food and Drug Administration and
Japa
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