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In Brief: Angeion Auracle 2020

This article was originally published in The Gray Sheet

Executive Summary

Angeion Auracle 2020: Next generation implantable cardioverter defibrillator is slated to enter clinical trials this summer, the firm states. Formerly designated the Sentinel 2020, the device has a volume of less than 50 cc, making it smaller than Angeion's 60 cc Sentinel 2000 and 2010 ICDs, for which Angeion hopes to submit premarket approval applications this summer ("The Gray Sheet" Feb. 26, 1996, I&W-16). The device also incorporates more advanced features than the earlier generation devices, Angeion says. The company has been seeking to terminate a distribution agreement for ICDs with St. Jude following St. Jude's announcement in October that it plans to acquire Ventritex and Telectronics ("The Gray Sheet" Oct. 28, 1996, p. 3). Discussions are under way with other potential distributors, Angeion says...
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