Breakthrough Device Designation for Infuse Bone Graft

Medtronic received FDA’s Breakthrough Device designation for Infuse bone graft with an intervertebral fusion device and a commercially available metallic screw and rod system.

This designation pertains to the use of Infuse bone graft in a transforaminal lumbar interbody fusion (TLIF) surgical approach at one or two adjacent levels from L2 – S1 in the treatment of degenerative disease of the lumbosacral spine.

Medtronic is enrolling patients in a prospective, randomized clinical trial for the use of Infuse in a TLIF approach at one or two adjacent levels from L2-S1. The trial aims to provide clinical evidence to demonstrate safety and effectiveness sufficient for expanding indications in TLIF.

Infuse has received FDA approval for specific spine, oral-maxillofacial and orthopedic trauma procedures. In spine surgery, it is utilized with select Medtronic interbody fusion devices for individuals with degenerative disc disease alleviating donor site pain by negating the necessity of harvesting bone from the patient’s body through a secondary surgical intervention.

“We appreciate the FDA’s recognition that Infuse has the potential to raise the standard of care in TLIF. With this designation, our goal is to broaden the availability of this established technology, reaching more patients affected by debilitating spine conditions,” said Michael Carter, Vice President and General Manager of Spine and Biologics within the Cranial and Spinal Technologies business, which is part of the Neuroscience Portfolio at Medtronic. “By expanding access to Infuse, we aim to empower healthcare providers with effective tools to address the challenges posed by degenerative spine conditions. Ultimately, our mission is to enhance the quality of life for individuals suffering from these conditions, fostering a future where patients can enjoy improved mobility and comfort.”

Source: Medtronic