The single-arm, 60-patient trial of patients with existing kidney dysfunction is designed to compare treatment with the RenalGuard device, which is designed to prevent contrast-induced nephropathy. The endpoint will compare CIN rates for the RenalGuard cohort with the expected rate of of acute kidney injury without the therapy, according to a press release.
"The Japanese market has the potential to be the 2nd-largest market in the world for RenalGuard, based upon the number of cath lab procedures and patients undergoing these procedures with existing at-risk conditions for CI-AKI. Once the study is concluded, the results will be submitted to the Japanese MHLW as part of a package for shonin approval from the agency. Completion of this process, if successful, would allow the importation of RenalGuard for sales and marketing in Japan," president & CEO Mark Tauscher said in prepared remarks.
The approval comes 2 years after Milford, Mass.-based PLC Systems won FDA approval to begin RenalGuard trials in the U.S. RenalGuard is also approved in countries that recognize the European Union’s CE Mark.