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Guidant

This article was originally published in The Gray Sheet

Executive Summary

U.S. shipments of the Discovery and Meridian next-generation pacemaker families are scheduled to begin May 5, following receipt of FDA approval April 30, the firm says. Approved via premarket approval application supplement to Guidant's Vigor pacemaker, the device families include single- and dual-chamber models with adaptive-rate pacing and advanced diagnostics. The devices incorporate Quick Start, Quick Check and Quick Notes features, designed to allow clinicians "to easily and quickly perform a comprehensive set of automatic tests and follow-up device operations," and provide a printout summarizing data needed for informed patient management, Guidant explains. The Discovery line also has the ability to store and display "diagnostic-quality atrial and ventricular electrograms simultaneously." The devices debuted in Europe in mid-March
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