October 14, 2011
PLC To Begin U.S. Trial For RenalGuard
The Food and Drug Administration has given the go-ahead to Milford-based medical device maker PLC Systems Inc. to begin a United States trial for its RenalGuard product.
The study builds on two previous European trials that showed reductions in incident rates of contrast-induced nephropathy, or CIN, PLC said. The condition can lead to renal failure and has a mortality rate of as high as 35 percent.
RenalGuard is designed to hydrate patients, which can help reduce the risk of developing CIN.
The trial will take place at 30 sites and will include anywhere from 326 to 652 patients.
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