Infuse Bone Graft: What Are Approved Uses?

posted in Bone Graft, Biologics, What's New

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Infuse Bone Graft is a man-made liquid form of bone morphogenetic protein, or BMP. It is implanted between vertebrae soaked in a sponge-like substance enclosed in a metallic cage. Ideally, BMP causes bone growth that fills in the gap between vertebrae to replace damaged disks.

Medtronic is the manufacturer of Infuse, and the product has generated huge sales for Medtronic, brining in over $3 billion in sales since it was approved in 2002. However, The Department of Justice began investigating the off-label use of a Infuse Bone Graft.

So what are the approved uses of Infuse Bone Graft? It appears that Infuse is only approved by the FDA for a small section of the spine in the lower, lumbar region.

However, it seems as if spine surgeons have been using Infuse Bone Graft for cases in the cervical spine. The FDA said it received 38 reports over four years of complications from cervical uses of Infuse. At a recent spine conference, a group of North Carolina surgeons reported on a study that found a complication rate of 59% in cervical spine surgeries with Infuse, as compared to a 21% complication rate using conventional fusion surgery, which involves bone grafts or collagen. The study, conducted between July 2005 and December 2007, examined 76 patients.

But is the number of Infuse problems really that large compared to the number of units sold to actually warrant an investigation? And who is to blame for off-label use of Infuse Bone Graft? Patients blame the doctors and doctors blame the Medtronic salesman. The question of course is whether Infuse may have medical advantages in areas not current approved by the FDA. Additional clinical trials conducted by Medtronic might expand approved uses of the product beyond those already allowed by the FDA.