The FDA approval of additional spine surgery indications for Medtronic's Infuse Bone Graft.
Here are five things to know:
1. The new indications for Infuse Bone Graft are:
- Use in OLIF51 Procedures with certain sizes of the PEEK Perimeter Implant at a single level from L5-S1
- Use in OLIF25 Procedures with certain sizes of the PEEK Clydesdale Implant at a single level from L2-L5
- Use in ALIF procedures with certain sizes of the PEEK Perimeter Implant at a single level from L2-S1
2. Upon receiving final labeling approval from the FDA, the company expects to begin marketing these expanded indications in early 2016.
3. With this expanded approval, Medtronic will be able to market Infuse Bone Graft for use with certain spine implants made of polyetheretherketone in oblique lateral interbody fusion and anterior lumbar interbody fusion procedures.
4. Infuse Bone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease, and is FDA-approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries.
5. Peter Whang, MD, associate professor in the department of orthopedics at the Yale School of Medicine in New Haven, Conn., said he believes 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 minimizes disruption of the surrounding soft tissues and neural structures.