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In Brief: Guidant

This article was originally published in The Gray Sheet

Executive Summary

Guidant: Firm's CPI subsidiary gains FDA approval via premarket approval application supplement for its Ventak PRx III automatic implantable cardioverter defibrillator system. The system, used in the treatment of tachycardia includes the PRx III biphasic pulse generator, the Endotak lead, and a program monitor. The PRx III pulse generator, 30% smaller than Guidant's currently marketed PRx and P2 devices, has been marketed in Europe since October 1994. According to Guidant, labeling for PRx III does not specify implantation location, but the firm notes that more that 50% of European patients have been implanted pectorally. The PRx III pulse generator lists for $19,900; the entire system will sell for $26,400...

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