Medtronic Infuse Saga Prompts Questions About FDA Approval Process
This article was originally published in The Gray Sheet
Executive Summary
Medtronic, responding last week to suggestions in the Spine Journal that financial ties to the company led researchers to hide serious adverse events associated with the firm's Infuse bone graft when writing up their studies for publication, defended itself by pointing out that the data on which FDA based its approval of the product contained no such omissions.
You may also be interested in...
No Advantage For Medtronic’s InFuse Versus Bone Graft In Spine Fusion
The long-awaited independent analysis of clinical data on Medtronic’s InFuse recombinant human bone morphogenetic protein-2 (rhBMP-2) found no advantages to using it as a substitute for traditional bone grafts in spinal fusion surgery, while also revealing that the risks of rhBMP-2 may be greater than has been previously reported.
Infuse Open-Access Project A Model For The Future? Medtronic Thinks So
Two independent analyses published on Medtronic’s Infuse biologic bone graft do not paint a positive picture for the device, but they do represent an important model for the future of open-access data analysis for drugs and devices, both Medtronic and academic proponents say.
No Advantage For Medtronic’s InFuse Versus Bone Graft In Spine Fusion
The long-awaited independent analysis of clinical data on Medtronic’s InFuse recombinant human bone morphogenetic protein-2 (rhBMP-2) found no advantages to using it as a substitute for traditional bone grafts in spinal fusion surgery, while also revealing that the risks of rhBMP-2 may be greater than has been previously reported.