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Medtronic Initiates Clinical Trial for Infuse Bone Graft in TLIF

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Medtronic (MDT) received FDA approval for a prospective, randomized pivotal clinical trial on the use of Infuse™ Bone Graft in transforaminal lumbar interbody fusion.

Site recruitment is underway, potentially enrolling over 1,000 subjects at 50 sites. 

In 2017, MDT received FDA approval of a separate clinical trial to study Infuse in posterolateral fusion (PLF). MDT enrolling its prospective pilot PLF clinical trial and working with FDA to incorporate retrospective safety and effectiveness data sufficient for indication expansion in PLF.

Infuse has been marketed since 2002, and used with certain MDT interbody fusion devices to treat degenerative disc disease at a single level.

Source: Medtronic