FDAnews
www.fdanews.com/articles/92055-fda-approves-medtronic-s-infuse-bone-graft

FDA APPROVES MEDTRONIC'S INFUSE BONE GRAFT

March 14, 2007

Medtronic announced the FDA has approved its Infuse bone graft for certain oral maxillofacial and dental regenerative bone grafting procedures.

The company said the Infuse bone graft could reduce the pain, scarring and surgical time related to these procedures, as well as provide an alternative for bone grafting procedures that do not commonly use autogenous bone grafts.

Autogenous bone grafts -- using bone harvested from other parts of the patient -- are currently the standard grafting procedure to generate or regenerate bone in sinus augmentations and localized alveolar ridge augmentations for defects associated with extraction sockets.

Medtronic noted that this is the third premarket approval application for this technology to receive FDA approval since 2002. The company said it expects the product to be available by March 26.