PLC Systems Receives Clinical Trial Approval in Japan

Japanese regulators have given their blessing to PLC Systems Inc. to conduct a clinical trial for contrast-induced acute kidney injury (CI-AKI) therapy.

Patients enrolled in the clinical trial will use PLC’s RenalGuard system to prevent AKI. The therapy currently is CE Marked and used throughout Europe.

“We are very excited to begin clinical studies with RenalGuard in Japan,” said Mark R. Tauscher, president/CEO of PLC Systems. “The Japanese market has the potential to be the second largest market in the world for RenalGuard, based upon the number of catheter 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 [Ministry of Health, Labor and Welfare] 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.” 

This single-arm clinical trial will enroll 60 patients at two sites. The objective of the study is 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 undergoing a catheterization procedure using contrast dye. The primary endpoint is combined incidence of CI-AKI and serious in-hospital therapy-related adverse events compared to the expected rate based on the patients’ risk factors.

Ichiro Michishita, M.D., a leading Japanese cardiologist and expert in CI-AKI, has successfully completed two cases utilizing RenalGuard for the prevention of CI-AKI at Yokohama Sakae Kyosai Hospital in Yokohama, Japan. Michishita is the director of Yokohama Sakae’s Cardiovascular Division.

“I am very pleased that the very first cases utilizing RenalGuard in Japan to prevent CI-AKI were successful,” Michishita 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.”

Michishita worked with the Japanese MHLW to outline a process for RenalGuard evaluation and approval in Japan. Following the initial two cases, Michishita met with the MHLW to present his findings and request approval for the initiation of the 60-patient study.

Headquartered in Milford, Mass., PLC Systems develops technologies for the cardiac and vascular markets. PLC’s newest product, RenalGuard, has been developed to rapidly remove contrast dyes that are potentially toxic to patients undergoing certain cardiac and vascular imaging procedures. Two investigator-sponsored European studies have demonstrated RenalGuard’s effectiveness at preventing Contrast-Induced Acute Kidney Injury (CI-AKI). RenalGuard currently is being studied in a pivotal clinical trial in the United States as part of the U.S. Food and Drug Administration approval process.