Medtronic has earned U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for the use of INFUSE Bone Graft in transforaminal lumbar interbody fusion (TLIF) procedures at one or two levels from L2–S1, with both PEEK and titanium interbody cages. 

The approval expands INFUSE’s versatility, making it the only PMA-approved growth factor bone graft for anterior lumbar interbody fusion (ALIF), oblique lateral lumbar interbody fusion (OLIF), and now TLIF—and the only growth factor bone graft product approved for spine fusion, including two-level constructs for TLIF, according to the company. 

The TLIF indication for INFUSE received FDA Breakthrough Device Designation in April 2024, recognizing its potential to offer more effective treatment options for patients with degenerative lumbar spine conditions. This designation supported enhanced FDA engagement and contributed to a prioritized review timeline. Medtronic submitted a panel-track PMA application on Aug. 18, 2025. The FDA approved the application 180 days later on Feb. 13, 2026—underscoring the strength and quality of the clinical evidence supporting INFUSE for TLIF. 

“Every patient considering TLIF places tremendous trust in us during one of the most challenging moments of their lives, and they deserve the very best chance at healing and returning to the life they love,” said Joseph Smucker, M.D., Indiana Spine Group (Indianapolis, Ind.), and global investigator for the INFUSE TLIF Study. “Expanding INFUSE Bone Graft to this widely used procedure brings a biologic solution that reliably supports the body’s natural healing process—an advancement grounded in years of rigorous study and a deep commitment to improving outcomes for patients and families everywhere.” 

The PMA approval is supported by a prospective, multicenter, randomized controlled clinical study evaluating one- and two-level TLIF procedures. A total of 493 patients were randomized one-to-one-to-one into three groups: INFUSE Bone Graft 2.1 mg/level, INFUSE Bone Graft 4.2 mg/level, and Local Bone Autograft. 

A 2025 FDA-approved protocol amendment incorporated a Bayesian adaptive design. Following the first interim analysis at 480 treated patients, the Independent Data Monitoring Committee determined the primary endpoints were met for both INFUSE dose groups and recommended stopping further enrollment. Patient follow-up continues to support comprehensive long-term data. 

In the study, INFUSE achieved fusion rates exceeding 90% in single-level TLIF and demonstrated comparably strong results in two-level constructs. Patients also showed earlier radiographic evidence of radiographic fusion compared to autograft, which may help reduce hardware stress and postoperative complications. 

“The FDA approval of INFUSE Bone Graft for TLIF is a major step forward for spine care,” said Christopher I. Shaffrey, M.D., neurosurgeon, Medtronic consultant, and independent expert in complex spine surgery who was not involved in the trial. “The strength of the clinical data, the versatility across levels and implant types, and the consistency of outcomes provide surgeons with a validated option for complex fusion cases. Having a PMA-approved biologic solution available for ALIF, OLIF, and now TLIF enhances our ability to tailor treatment to the individual needs of each patient.” 

TLIF is one of the most commonly performed lumbar fusion procedures for patients with degenerative disc disease, disc herniation, or spinal instability. With this approval, INFUSE Bone Graft can now be used as an option in indicated TLIF procedures, including with titanium or PEEK cages—static or expandable—and in two-level constructs. The approval also supports use in patients with up to Grade 2 spondylolisthesis or Grade 2 retrolisthesis and offers multiple dose options to match graft volume to case demands. INFUSE’s radiolucent profile improves postoperative imaging, and its handling characteristics support consistent, efficient placement in the operating room. 

Medtronic Cranial and Spinal Technologies is striving to transform the standard of care in spine and cranial surgery by addressing the complex challenges faced by spine and neurosurgeons. With 150 products covering more than 20 pathologies, Medtronic Cranial and Spinal Technologies serves over 4 million patients annually. Its AiBLE ecosystem integrates advanced technologies, data, and artificial intelligence (AI) with a patient-centric approach, offering customizable solutions to enhance surgical precision, improve workflow efficiency, and achieve better outcomes, before, during, and beyond surgery. 

Headquartered in Galway, Ireland, Medtronic is the world’s largest healthcare technology company, employing more than 95,000 workers across 150-plus countries. Its technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. The company delivers innovative technologies that transform the lives of two people every second, every day.