PLC Systems, Inc. (PLCSF) Approved by Japanese Military of Health, Labor, and Welfare to Commence Clinical Trial

PLC Systems, a medical device company focused on innovative technologies for the cardiac and vascular markets, reports that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved the initiation of a clinical trial in Japan using the company’s RenalGuard Therapy®.

The approval follows a thorough review of previously published studies of RenalGuard Therapy as well as of data from two cases where Japanese physicians used RenalGuard® to protect patients at risk of Contrast-Induced Acute Kidney Injury (CI-AKI). RenalGuard is currently CE-Marked and being distributed throughout Europe to prevent AKI.

“We are very excited to begin clinical studies with RenalGuard in Japan,” Mark R. Tauscher, president and CEO of PLC Medical Systems stated in the news release. “The Japanese market has the potential to be the second 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.”

The clinical trial is designed to enroll 60 patients at two sites to evaluate the ability of RenalGuard Therapy to reduce the incidence of CI-AKI in at risk patients when compared to the expected rate of CI-AKI. The study will enroll patients with pre-existing kidney dysfunction that are currently undergoing a catheterization procedure using contrast dye.

Upon completion of the clinical trial, the results will be submitted to the Japanese MHLW as part of a package for shonin approval from the agency. This process, once completed, would allow for the importation of RenalGuard for sales and marketing in Japan.

Dr. Ichiro Michishita, a leading Japanese cardiologist and expert in CI-AKI, has completed two cases utilizing RenalGuard for the prevention of CI-AKI at Yokohama Sakae Kyosai Hospital in Japan, and noted the success of both.

“I am very pleased that the very first cases utilizing RenalGuard in Japan to prevent CI-AKI were successful,” he said. “I am very impressed with the ease of use of the system, and how it works to maintain the fluid balance of the body. Once it is approved by the MHLW, I believe that RenalGuard will be a great benefit for patients undergoing PCI requiring contrast media.”

For more information, visit www.plcmed.com

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