ANS PMA For Genesis SCS System Relies on Clinical Literature Studies
This article was originally published in The Gray Sheet
Executive Summary
Advanced Neuromodulation Systems supported the efficacy of its recently approved Genesis implantable spinal cord stimulator (SCS) using three clinical studies performed with Medtronic's SCS system
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Cryolife
CDC confirms presence of rare bacterium Clostridium sordellii in Cryolife-processed human donor condyle tissue implanted in a 23-year old Minnesota knee surgery patient who died Nov. 11; the bacterium was not found or implicated in two other Minnesota total knee replacement patient deaths. Cryolife does not intend to alter its processing protocols after CDC, FDA and the Minnesota Department of Health found no connection between the deaths and made no recommendations for changes (1"The Gray Sheet" Dec. 10, 2001, In Brief)...
Cryolife
CDC confirms presence of rare bacterium Clostridium sordellii in Cryolife-processed human donor condyle tissue implanted in a 23-year old Minnesota knee surgery patient who died Nov. 11; the bacterium was not found or implicated in two other Minnesota total knee replacement patient deaths. Cryolife does not intend to alter its processing protocols after CDC, FDA and the Minnesota Department of Health found no connection between the deaths and made no recommendations for changes (1"The Gray Sheet" Dec. 10, 2001, In Brief)...
ANS Genesis Totally Implantable Spinal Cord Stimulator Gains FDA Approval
Advanced Neuromodulation Systems says it will launch its Genesis totally implantable pulse generator (IPG) spinal cord stimulation (SCS) system in January. FDA approval of the device was announced Nov. 21