Infuse Gets A Lashing In Spine Journal Over New Sterility Data
This article was originally published in The Gray Sheet
Executive Summary
A single-center analysis of spinal fusion procedures concluded last week that Medtronic's Infuse biologic bone graft is linked to an increased risk of male sterility, initiating a round of recriminations against the struggling product by some in the orthopedic community.
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Medtronic Infuse Saga Prompts Questions About FDA Approval Process
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.
Medtronic Infuse Saga Prompts Questions About FDA Approval Process
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.
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