Medtronic’s Infuse bone protein is a safe and effective treatment for use in facial and dental bone grafting procedures, the company told US Food and Drug Administration (FDA) reviewers.
The comments were made public ahead of a FDA advisory panel meeting to discuss whether or not to approve the new use. Infuse is already approved for certain lower-back procedures and some severe leg fractures.
“The benefits of Infuse clearly outweigh the risks,” according to the company. “Infuse bone graft results in sufficient bone growth for dental implant placement and functional restoration with significantly fewer adverse events and a better overall safety profile than bone graft, autograft alone or in combination with allograft, which is the standard of care for oral maxillofacial procedures.”
Medtronic is seeking FDA approval to market the product, for use in bone- graft surgery of the mouth, jaw, and facial area.
[Reuters, December 8, 2006]