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WASHINGTON, Nov 8 (Reuters) - Medtronic Inc's (MDT.N: Quote, Profile, Research) Infuse bone protein is a safe and effective treatment for use in facial and dental bone grafting procedures, U.S. Food and Drug Administration staff reviewers said on Wednesday.
Their comments were made public ahead of a FDA advisory panel meeting on Thursday 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," the FDA staff said, referring to facial use in patients.
"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," the FDA staff said.
Medtronic is seeking FDA approval to market the product, a collagen material that contains a bone protein, for use in bone graft surgery of the mouth, jaw and facial area.
The FDA usually, but not always, follows the recommendation of its outside advisers.
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