Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


FDA panel backs InFUSE bone graft for spinal fusion

This article was originally published in Clinica

Executive Summary

An FDA advisory panel has unanimously recommended that the agency approve for marketing what promises to be a breakthrough product, a genetically-engineered protein that has been under development for three decades to spur bone growth. If the agency goes along with the endorsement, Medtronic Sofamor Danek's InFUSE bone graft for use in spinal fusion procedures could represent the first major clinical use of a bone growth factor to be widely available to patients. Another bone growth protein, Stryker's OP-1, is only available via a limited humanitarian device exemption for treating recalcitrant long bone nonunions.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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