Medtronic has announced US Food and Drug Administration (FDA) approval of additional spine surgery indications for Infuse Bone Graft
Upon receiving final labelling approval from the FDA, Medtronic will be able to market Infuse Bone Graft for use with certain spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF) and anterior lumbar interbody fusion (ALIF) procedures.
Infuse Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease.
This condition can cause back and/or leg pain, as well as functional problems, such as tingling or numbness in the legs or buttocks or difficulty walking.
Peter Whang, associate professor in the department of orthopaedics at the Yale School of Medicine in New Haven, said: "For my anterior and anterolateral lumbar spine fusion cases, the use of Infuse Bone Graft allows me to reliably obtain a solid arthrodesis without having to harvest bone from the patient's own hip which generally requires a second incision, results in significant pain and increases the risk of complications such as bleeding or infection.
“In particular, I believe that the proven osteoinductive properties of Infuse Bone Graft are particularly beneficial when used in conjunction with PEEK interbody spacers and the less invasive OLIF technique, which circumvents the psoas muscle and minimises disruption of the surrounding soft tissues and neural structures."
There is an active ingredient in Infuse Bone Graft - rhBMP-2 – which is a manufactured version of a protein already present in the body that promotes new bone growth.
During surgery, it is applied to an absorbable collagen sponge (ACS). The ACS is a carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for the formation of new bone, and it will resorb, or disappear, over time.
The OLIF25 Procedure helps surgeons preserve the patient's psoas muscle when treating the L2-L5 levels of the spine.
Additionally, it gives surgeons easier access around the patient's iliac crest - enabling placement of an implant into the disc space for anterior column support.
The OLIF51 Procedure provides lateral access to the L5-S1 disc space and doesn't require surgeons to flip the patient from an anterior position during surgery.
OLIF Procedures incorporate Medtronic's surgical platform of access, interbody, navigation, fixation and biologic options.