Guidant Galileo
This article was originally published in The Gray Sheet
Executive Summary
PMA supplement is filed with FDA for a next-generation version of the intravascular radiation system for in-stent restenosis that incorporates an automated "stepping function" to automatically reposition the radiation source and facilitate treatment of long lesions. Called the GalileoIII, the device uses a third generation centering catheter, Guidant explains. The current version of the system, approved Nov. 2, permits treatment of long lesions via manual tandem repositioning (1"The Gray Sheet" Nov. 12, 2001, p. 3). Pending approval, customers with existing systems will be upgraded at no additional cost, the firm says...
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