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Medtronic announced FDA Premarket Approval 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. This approval expands the versatility of INFUSE, making it the only PMA-approved growth factor bone graft for ALIF, OLIF, and now TLIF—and the only growth factor bone graft product approved for spine fusion, including 2-level constructs for TLIF.
The TLIF indication received FDA Breakthrough Device Designation in 2024, recognizing its potential to offer more effective treatment options for patients with degenerative lumbar spine conditions.
The PMA approval is supported by a prospective, multicenter, randomized controlled clinical study evaluating one- and two-level TLIF procedures; 493 patients were randomized 1:1:1 into three groups:
- INFUSE Bone Graft 2.1 mg/level
- INFUSE Bone Graft 4.2 mg/level
- 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 that 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 percent 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.
With this approval, INFUSE can now be used as an option in indicated TLIF procedures, including with titanium or PEEK cages—static or expandable—and in 2-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.
Source: Medtronic
Medtronic announced FDA Premarket Approval 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. This approval expands the versatility of INFUSE, making it the only PMA-approved growth factor bone graft for ALIF, OLIF, and now...
Medtronic announced FDA Premarket Approval 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. This approval expands the versatility of INFUSE, making it the only PMA-approved growth factor bone graft for ALIF, OLIF, and now TLIF—and the only growth factor bone graft product approved for spine fusion, including 2-level constructs for TLIF.
The TLIF indication received FDA Breakthrough Device Designation in 2024, recognizing its potential to offer more effective treatment options for patients with degenerative lumbar spine conditions.
The PMA approval is supported by a prospective, multicenter, randomized controlled clinical study evaluating one- and two-level TLIF procedures; 493 patients were randomized 1:1:1 into three groups:
- INFUSE Bone Graft 2.1 mg/level
- INFUSE Bone Graft 4.2 mg/level
- 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 that 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 percent 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.
With this approval, INFUSE can now be used as an option in indicated TLIF procedures, including with titanium or PEEK cages—static or expandable—and in 2-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.
Source: Medtronic
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
