PLC has announced that it has received approval from the Israeli Ministry of Health to market its RenalGuard system for the prevention of contrast-induced nephropathy in Israel. The company also has announced that it will distribute RenalGuard through AMI Technologies.
“RenalGuard offers us a potential method to reduce the incidence of contrast-induced nephropathy, a major issue when performing interventional procedures requiring contrast agents with high-risk patients. I am very pleased to have the opportunity to utilise RenalGuard therapy, especially after seeing the positive results presented in both the REMEDIAL II and MYTHOS trials, and look forward to continued use of the system,” said Eugenia Nikolsky, director, Cardiovascular Research Unit, Rambam Medical Center, Haifa, Israel, physician who successfully completed the first patient case in Israel using RenalGuard.
“Today’s news enables PLC to expand the use of RenalGuard into the Middle East,” said Mark R Tauscher, president and CEO, PLC. “AMI is an established, successful distributor and will help in our efforts to increase worldwide adoption of RenalGuard. Many Israeli cardiologists, such as Dr Nikolsky, are considered thought leaders in interventional cardiology worldwide. Our success in receiving approval to market RenalGuard in Israel should help us continue to drive adoption of RenalGuard worldwide.”
PLC already has distribution agreements for RenalGuard in Europe. A US pivotal trial of RenalGuard to support FDA approval began in late 2011.