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In Brief: Angeion Sentinel

This article was originally published in The Gray Sheet

Executive Summary

Angeion Sentinel: Implantable-cardioverter-defibrillator system will be launched in Europe within 30 to 60 days, following receipt of the European Union's CE mark, the Minneapolis firm announces. Angeion has distribution agreements to market the Sentinel in the United Kingdom, Belgium, Luxembourg, The Netherlands, Germany and Italy, and is in the process of securing distribution channels for the remaining EU countries. Phase I U.S. trails for the ICD system, which will include 60 patients at 15 sites, began in March under an investigational device exemption granted by FDA in November ("The Gray Sheet" Feb. 26, I&W-1)...
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