The spinal division (Memphis, Tennessee) of Medtronic (Minneapolis) reported that the FDA has granted an investigational device exemption (IDE) to conduct a clinical trial to study Infuse Bone Graft in a cervical spinal fusion.

The investigational device will consist of Infuse Bone Graft inside a polyetheretherketone (PEEK) polymer interbody spacer used with an anterior cervical plate as a method of facilitating spinal fusion. The Infuse Bone Graft/LT-Cage device is designed to restore degenerated disc space to its original height

The goal of the trial is to evaluate whether Infuse Bone Graft is a safe and effective alternative to traditional bone grafting techniques for cervical spine fusions, the company said.

“The objective of this study is to demonstrate that Infuse Bone Graft combined with a PEEK spacer and anterior cervical plate is a safe and proven treatment that induces reliable fusions,” said Ken Burkus, MD, a spine surgeon from Columbus, Georgia.

Infuse Bone Graft is a bone growth protein currently approved for use in an anterior lumbar interbody fusion (ALIF) procedure in combination with a metallic cage implant. The active ingredient in Infuse Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2). The intent of this study is to expand the approved indications to include anterior cervical fusion procedures.

“Infuse is a protein, it generates bone growth,” a Medtronic spokesperson told Medical Device Daily. “At least, that’s what it’s shown in the lumbar spine [and] that’s part of this trial to determine if it works just as well in the cervical spine as it does in the lumbar spine.”

The spokesperson said that Medtronic is “hopeful” that the new trial would demonstrate that Infuse is equally effective in the cervical spine.

Since its initial release in July 2002 as the active component in Infuse Bone Graft, rhBMP-2 had been used to treat more than 150,000 patients as of September 2005, according to Medtronic (Medical Device Daily, Sept. 30, 2005).

In September, Medtronic reported that an article in The Journal of Bone and Joint Surgery (June 2006) shows that Infuse Bone Graft, recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge, helped patients with severe tibial trauma heal sooner and reduced the need for a follow-up bone graft to treat a delayed mending of the treated bones (MDD, September12, 2006).

The article reported that patients who received Infuse Bone Graft also had a significantly lower rate of post-operative infection and could place load-bearing weight on their injured legs faster than those who did not receive the graft.

Medtronic reported in January that the Australian Therapeutic Goods Administration approved the company’s Infuse Bone Graft/LT-Cage, Inter Fix and Inter Fix RP devices for spinal fusion (MDD, Jan. 30, 2006).

In the U.S., more than 200,000 individuals undergo spine fusions to treat degenerative changes in the cervical spine, according to Medtronic.