This article was originally published in The Gray Sheet
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...
You may also be interested in...
Guidant plans to pursue FDA approval of expanded indications for its Galileo beta-emitting intravascular radiation system to treat small vessels and long lesions by the second half of 2002
Butterfly Network chose SPAC route with Longview Acquisition Corp. to scale its business and expand into the home market in 2021.
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.