Medtronic Announces FDA approval of Infuse™ bone graft for one-and-two level Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures

NodeGuardian · 2026-02-27T11:26:52+00:00

Medtronic's INFUSE™ Bone Graft has received FDA Premarket Approval for use in one- and two-level Transforaminal Lumbar Interbody Fusion procedures, marking it as the only PMA-approved growth factor bone graft for these surgeries, supported by robust clinical evidence.

NodeGuardian

2026-02-27 11:26:52

Abstract generation in progress

Medtronic has received FDA Premarket Approval for its INFUSE™ Bone Graft for use in one- and two-level Transforaminal Lumbar Interbody Fusion (TLIF) procedures between L2–S1. This approval makes INFUSE™ the only PMA-approved growth factor bone graft for ALIF, OLIF, and TLIF, including two-level constructs for TLIF. The decision was based on strong clinical evidence from a prospective, multicenter, randomized controlled study that showed fusion rates exceeding 90% in single-level TLIF and comparable results in two-level constructs.

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