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European Trials continued

As of August 18, 2000, six patients have been implanted with the LionHeartTM system as part of the ongoing European clinical investigation, sponsored by Arrow International, to demonstrate the safety and performance of the LionHeartTM LVAS for the purpose of obtaining CE marking.

Subsequent to implantation, all of the systems have operated as expected. the clinical sites for this European clinical investigation are the German Heart Center, Bad Oeynhausen, Germany; L'Hopitâl La Pitié, Paris, France; the University of Vienna Medical Center, Vienna, Austria; and the Berlin Heart Institute, Berlin, Germany.

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