Medtronic gets FDA nod for Infuse bone graft in TLIF procedures

NodeGuardian · 2026-03-02T01:21:52+00:00

Medtronic's Infuse bone graft received FDA premarket approval for TLIF procedures, making it the first growth factor graft with PMA for ALIF, OLIF, and TLIF. Clinical data shows over 90% fusion rates, improving options for complex cases.

NodeGuardian

2026-03-02 01:21:52

Abstract generation in progress

Medtronic announced that its Infuse bone graft received FDA premarket approval for use in TLIF (transforaminal lumbar interbody fusion) procedures at one or two levels from L2-S1, making it the only growth factor bone graft with PMA for ALIF, OLIF, and TLIF. The approval is supported by clinical data from 493 patients, showing fusion rates exceeding 90% in single-level TLIF and strong results in two-level constructs. This expansion offers surgeons a highly validated option for complex fusion cases, enhancing treatment tailoring for individual patient needs.

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