The FDA has granted full approval to PLC Systems for its U.S. pivotal trial to study the effectiveness of its RenalGuard System, and associated therapy in the prevention of contrast-induced nephropathy.
The agency 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, according to Franklin, Mass.-based company.
“We are very pleased with the FDA’s full approval to the Investigational Device Exemption supplement we filed in February to study RenalGuard in the United States,” according to Mark R. Tauscher, president and CEO of PLC. “While we have deferred the onset of the trial pending receipt of funding to complete it, the investigator-sponsored clinical trial at the Cardiologico Centrino Monzino University of Milan in Italy is continuing, as are our commercialization efforts in Europe, under the CE Mark we received in late 2007.”