Medtronic Reaches Milestone to Submit Infuse Bone Graft for TLIF

Medtronic revealed a significant milestone in its Infuse bone graft for TLIF investigational device exemption (IDE) study, a randomized controlled trial on Infuse bone graft in the transforaminal lumbar interbody fusion (TLIF) procedure used in spine surgery.

After the first interim analysis, the independent Data Monitoring Committee (DMC) determined the study met the criteria for early success. Based on the assessment, the DMC recommended halting further enrollment in the trial.

Medtronic is now preparing a premarket approval (PMA) submission to the U.S. Food and Drug Administration (FDA).

In April, the FDA approved a protocol amendment that reduced the overall sample size and introduced a Bayesian adaptive design to allow interim analysis of study endpoints. The study’s design continued evaluation of two dose levels of Infuse and incorporated both PEEK and titanium cages.

Infuse for the TLIF indication earned FDA breakthrough status in April 2024. The potential new indication could expand treatment options for spine surgery patients. TLIF is a spinal fusion surgery to stabilize the lower back and alleviate pain caused by degenerative disc disease or disc herniation. It involves removal of a damaged disc, placing a spacer with bone graft material, and using screws and rods to fuse the adjacent vertebrae.

Medtronic said though this milestone is a significant achievement, there’s much work to be done. The PMA process requires rigorous evaluation, which the company said it will navigate will speed, efficiency, and accuracy. The study’s design, which features a diverse dataset with contributions from international patients, is an opportunity to demonstrate Infuse for TLIF’s broad applicability.

The company is also preparing to file for New Technology Add-on Payment (NTAP) with the U.S. Centers for Medicare & Medicaid Services (CMS) shortly after submitting the PMA.

“Our teams are deeply dedicated to seeing this process through to completion,” said Dave Breiter, vice president of Clinical, Medical, Regulatory Affairs and Health Economics for Medtronic’s Cranial & Spinal Technologies business. “We are prepared to work collaboratively with the FDA to address all aspects of the PMA submission and ensure we deliver a high-quality application that meets the highest standards.”