Bioactive Technologies For Bone Replacement

Once considered the Holy Grail in bone repair, Medtronic PLC's Spinal and Biologics Division's INFUSE Bone Graft, the first bone growth factor approved for use in the US, raised the bar in terms of clinical efficacy and has dominated the market for bone replacement materials since its approval in 2002. This recombinant bone morphogenetic protein (rhBMP)-2 has the ability to induce bone growth acroßs a repair site resulting in predictable healing and was PMA approved for use in conjunction with Medtronic's LT-CAGE for treating degenerative disc disease of the lumbar spine. Delivered on a bovine collagen sponge placed within an interbody fusion cage, INFUSE achieved rapid adoption after its release, primarily because it obviated the need to harvest an iliac crest bone graft from a secondary operative site, which is the major source of postoperative pain following spinal fusion. In 2004, INFUSE received a second PMA approval for repair of open long-bone fractures of the tibia. The company has completed an additional Investigational Device Exemption (IDE) study for posterolateral fusions and has another one for cervical fusion underway.

Today, INFUSE remains the only BMP that is PMA approved in the US. Its sole competitor, Stryker Corp.'s OP-1 (rhBMP-7), is approved under a Humanitarian Device Exemption (HDE) with...