Roughly 7 million patients worldwide receive interventional cardiovascular therapeutic and diagnostic imaging procedures each year. Approximately 15 percent to 20 percent of all patients undergoing such procedures are at risk of developing Contrast-Induced Nephropathy (CIN), the third leading cause of in-hospital acute renal failure.
Medical device company PLC Systems Inc. (OTCBB: PLCSF) develops cardiac and vascular technologies primarily in the United States. The company today announced it has received full approval from the U.S. Food and Drug Administration (FDA) regarding the company’s RenalGuard System, which was developed for interventional cardiology and radiology patients to eliminate toxins.
The FDA approved the company’s U.S. pivotal trial to study the effectiveness of the RenalGuard System, as well as associated therapies for the prevention of CIN.
“We remain very confident that RenalGuard is a highly promising therapy addressing a large, unmet market need. We are optimistic that the results from the CCM study will provide critical validation for our technology, and support our efforts to raise funding for the U.S. pivotal study as well,” Mark R. Tauscher, president and CEO of PLC stated in the press release.
The FDA also approved the company’s request to expand its study from 246 participants to 406 participants and to eliminate an interim study analysis. Tauscher said the approvals are an achievement that will enable the company to continue to introduce RenalGuard to the U.S. market.
“We are very pleased with the FDA’s full approval to the Investigational Device Exemption (IDE) supplement we filed in February to study RenalGuard in the U.S. 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 (CCM) - University of Milan in Italy is continuing, as are our commercialization efforts in Europe, under the CE Mark we received in late 2007. Full FDA approval of the IDE supplement is another major milestone on our path forward to commercializing RenalGuard in the U.S., and with its receipt, we are well-positioned to begin the trial with our targeted study sites, once we have the needed funding,” Tauscher stated.
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