Medtronic announced that it has secured FDA premarket approval (PMA) permitting the use of its Infuse bone graft in TLIF procedures. The authorization applies to TLIF (transforaminal lumbar interbody fusion) procedures performed at one or two levels from L2-S1, and covers use with both PEEK and titanium interbody cages.
According to the company, the latest PMA broadens the scope of Infuse, positioning it as the only growth factor bone graft with PMA across ALIF, OLIF and now TLIF procedures. The approval also represents the first time a growth factor bone graft has been cleared for spine fusion in TLIF, including two-level constructs.
Infuse for TLIF previously received FDA breakthrough device designation in April 2024. In July 2025, Medtronic reached a significant milestone toward full approval when, after the first interim analysis, the independent Data Monitoring Committee (DMC) concluded that the company’s FDA investigational device exemption (IDE) study of Infuse for TLIF procedures satisfied the predefined criteria for early success.
Medtronic supported its PMA submission with clinical findings drawn from 493 patients. In single-level TLIF cases, Infuse achieved fusion rates exceeding 90%, while two-level constructs produced similarly strong outcomes. The company further reported that patients demonstrated earlier radiographic evidence of fusion compared to autograft, a factor that may lessen hardware stress and help reduce post-operative complications.
With the new approval in place, Infuse becomes available as an option for indicated TLIF procedures. The labeling includes patients presenting with up to Grade 2 spondylolisthesis or Grade 2 retrolisthesis. The product also provides multiple dose options designed to align graft volume with case-specific requirements. Medtronic noted that Infuse features a radiolucent profile intended to improve post-operative imaging, along with handling characteristics aimed at supporting consistent and efficient placement in the operating room.
“The FDA approval of Infuse bone graft for TLIF is a major step forward for spine care,” said Dr. Christopher I. Shaffrey, 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 highly 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.”
In February 2017, Medtronic agreed to settle nearly all of thousands of lawsuits connected to Infuse. The legal claims alleged that the company promoted off-label uses of the product that resulted in personal injury.