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Franklin, MA - PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, announced recently that it has entered into a 3-year exclusive agreement with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy. Artech is one of Italy's leading distributors of interventional cardiology-related medical devices, doing business with most of Italy's major interventional cardiology centers. Artech will target early adopters who recognize the benefits of utilizing the unique fluid balancing capabilities of RenalGuard System in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of Contrast-Induced Nephropathy (CIN).

As part of this agreement, Artech placed an initial stocking order for 90,000 Euros (approximately $144,000) for RenalGuard Consoles and Single Use Sets to support the initial sales launch of RenalGuard at selected major cardiology centers throughout Italy.

PLC's President and Chief Executive Officer, Mark R. Tauscher, said, "We are extremely pleased with our new agreement with Artech in Italy. Our initial launch in Italy will be supported by the previously announced planned clinical trial at the Centro Cardiologico Monzino (CCM-University of Milan) in Milan, Italy. This study, which will be led by Drs. Antonio Bartorelli and Giancarlo Marenzi, two of the world's leading experts in the prevention of CIN, is expected to receive final approval by the ethics committee at CCM this spring and lead to increased market visibility for our RenalGuard System."

Artech's President, Emilio Contini, added, "RenalGuard offers Artech the opportunity to represent an innovative new therapy that can potentially improve the outcomes in interventional procedures requiring contrast for high risk patients. We are excited about the potential for the RenalGuard System in the Italian market, and we look forward to undertaking a successful launch here."

PLC received the CE Mark Certificate for the RenalGuard System in late December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received conditional approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of its RenalGuard Therapy and RenalGuard System in the prevention of CIN.

Contrast-Induced Nephropathy
Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre- existing renal failure - all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. CIN is the third most common cause of in-hospital acute renal failure. It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and the risk of having to undergo renal dialysis therapy. Any of these can result in prolonged hospital stays and increased medical costs. Studies indicate that approximately 15-20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN. The estimated mortality rate for patients that acquire CIN may be as high as 35%.

RenalGuard is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.

SOURCE: PLC Systems Inc.