A panel of medical experts is recommending that U.S. regulators approve a new use for
Infuse bone graft by expanding its indications to oral and maxillofacial procedures.
The Food and Drug Administration's Dental Products Advisory Panel unanimously voted to support the approval on the condition of specific product labeling. This will be the third premarket approval application filed for the bone graft since 2002, Medtronic says.
The most recent submission was primarily based on data from safety and effectiveness trials involving 312 patients who were evaluated for three years for, among other things, the ability to chew.
Medtronic's Infuse bone graft consists of a human bone protein applied to an absorbable collagen sponge carrier to stimulate bone formation. The graft was previously approved for certain lumbar spine fusion procedures as well as the repair of fractures of the larger shin bone called the tibia.