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CADENCE/ENDOTAK APPROVAL FOR COMBINATION USE

This article was originally published in The Gray Sheet

Executive Summary

CADENCE/ENDOTAK APPROVAL FOR COMBINATION USE establishes the first commercially available system using a biphasic automatic implantable cardiac defibrillator and transvenous leads. Sunnyvale, California-based Ventritex announced Oct. 28 that it received approval from FDA for a premarket approval supplement, filed in Sept. 1993, to expand the labeling of its Cadence V-100 and V-110 defibrillators to include their use with Cardiac Pacemakers, Inc.'s Endotak 60 and 70 transvenous leads.
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