Guidant gains FDA thumbs-up for INSIGNIA pacemaker:
This article was originally published in Clinica
Executive Summary
The US FDA has approved Guidant's new platform of pacemakers, called INSIGNIA. The devices, for treating cardiac rhythm disorders, are smaller than Guidant's previous pacemakers and employ the firm's unique teardrop shape design, which is intended to facilitate their implantation and to provide patient comfort. The new devices, which also offer improved longevity over their predecessors, are scheduled for launch during the second quarter of 2002.