PLC Systems of Franklin, MA, has signed an exclusive three-year agreement with Artech of Cavezzo, Italy, to distribute PLC's RenalGuard system in that country.
Artech already has placed an initial order valued at 90,000 euros ($144,000 U.S.) for RenalGuard consoles and accessories to support the initial launch of the system at cardiology centers throughout Italy.
PLC received the CE Mark in December 2007 to market RenalGuard in Europe.
The company concluded a pilot safety trial in the U.S. late last year and has received conditional approval from the U.S. Food and Drug Administration to commence a U.S. trial to study the effectiveness of RenalGuard therapy and the RenalGuard system to prevent contrast-induced nephropathy.
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PLC to enroll patients in CIN study, March 21, 2008
PLC Systems unveils CIN prevention technology, September 15, 2006
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