FDA gives go ahead for TLIF clinical trial

The FDA has granted Medtronic approval to start a new clinical trial to evaluate the use of Infuse bone graft in transforaminal lumbar interbody fusion (TLIF) spine procedures, specifically in certain spine, oral-maxillofacial and orthopedic trauma surgeries. Medtronic reports that since 2002, the Infuse bone graft has been commercially available in the market and used in more than two million patients across the world to date, and that the application of Infuse bone graft in TLIF procedures is limited to investigational only. Medtronic has started site recruitment for the TLIF clinical trial, and wants to recruit up to 1,000 patients at 50 sites.
Jacob Paul, Medtronic’s Spine division president and senior vice president, said: “With 17 years of clinical use, Infuse Bone Graft has become one of the most extensively-researched biologic technologies commercially available today.”
Dr Joseph Smucker, Indiana Spine Group orthopaedic spine surgeon and the trial principal investigator, said: “The potential to expand the indications for use of Infuse in posterior spine procedures may give a broader group of patients access to this novel biologic technology.”