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Medtronic wins FDA breakthrough nod for Infuse bone graft in TLIF

Medtronic (NYSE: MDT)+ announced today that the FDA granted breakthrough device designation for its Infuse bone graft.

This applies to the use of Infuse with an intervertebral fusion device and a commercially available metallic screw and rod system. The designation pertains to the use of Infuse in a transforaminal lumbar interbody fusion (TLIF) surgical approach. It extends to one or two adjacent levels from L2 – S1 in treating degenerative disease of the lumbosacral spine.

Infuse already has FDA approval for specific spine, oral-maxillofacial and orthopedic trauma procedures. In spine surgery, it works with select Medtronic interbody fusion devices. The graft treats those with degenerative disc disease alleviating donor site pain. It negates the necessity of harvesting bone from the patient’s body through a secondary surgical intervention. Infuse remains investigational in TLIF use at this stage.

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