In Brief: InControl
This article was originally published in The Gray Sheet
Executive Summary
InControl: Announces first implantation of its Metrix 3020 atrial defibrillator at the Universitair Ziekenhuis Gent in Ghent, Belgium. The 3020 incorporates "a new waveform which allows the device to deliver up to a maximum of six joules of energy," compared to the three joule capability of the firm's first-generation Metrix 3000. Early clinical study data comparing the two waveforms have demonstrated that the 3020 waveform "results in improved patient tolerance at similar defibrillation thresholds," InControl states. An investigational device exemption for the 3020 was submitted to FDA the week of Aug. 26...