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.
Medtronic has enrollment underway for a prospective, randomized clinical trial evaluating Infuse in a TLIF approach. It aims to provide clinical evidence to demonstrate safety and effectiveness sufficient for expanding indications in TLIF.
“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, VP and GM of Spine and Biologics 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.”
The breakthrough device designation news comes nearly seven years after Medtronic agreed to settle nearly all of the thousands of lawsuits claiming that the company promoted off-label uses of Infuse that resulted in personal injury.
