Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT030308

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel