Medtronic Scores Additional Approvals for Infuse Bone Graft
The FDA has awarded Irish devicemaker Medtronic with additional spine surgery indications for its Infuse Bone Graft.
The approval enables the device giant to market its product for use with certain spine implants made of polyetheretherketone in oblique lateral interbody fusion and anterior lumbar interbody fusion procedures.
Specific indications include 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; and use in ALIF procedures with certain sizes of the PEEK Perimeter Implant at a single level from L2-S1.
Medtronic’s Infuse Bone Graft is used with the company’s interbody fusion devices to treat lumbar degenerative disc disease. — Michael Cipriano