March 27, 2009 - The first data from PLC Systems’ pilot safety trial for RenalGuard will be presented in a poster session at the American College of Cardiology Annual Conference, on Sunday, March 29, 2009 in Orlando, FL.
The first in-man study involving RenalGuard in the U.S. was designed to test the safety of the RenalGuard System when used to provide high volume matched diuresis in patients at high risk for contrast-induced nephropathy (CIN) undergoing angiography. The 23-patient study was completed in late 2007. The lead investigator for the trial was Frederic S. Resnic, M.D., director of the cardiac catheterization lab at Brigham and Women’s Hospital.
“Our conclusion was that the system demonstrated effective high volume fluid balancing with acceptable safety. Further evaluation of system efficacy at preventing CIN is warranted,” Dr. Resnic said.
In November 2008, the company received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of RenalGuard and its associated therapy in the prevention of CIN. Under the trial design, 406 patients will be enrolled at up to 30 institutions.
For more information: www.plcmed.com