Medtronic Gets New FDA Infuse OK

Minneapolis, MN-based Medtronic said that the FDA expanded the marketing approval of the company’s Infuse bone graft for a variety of dental and facial reconstruction uses, according to the Associated Press.

Specifically, the agency approved Infuse for certain oral maxillofacial and dental regenerative bone grafting procedures. The affected area comprises the head, neck, face, jaws and the hard and soft tissues. The medical device manufacturer estimates the new approval will allow Infuse to be used in more than 350,000 bone grafting procedures per year, when previously a patient’s own bone needed to be harvested from other sites for a graft.

The FDA approval marks the third one the company has received since 2002. Infuse is already approved for certain lumbar spine fusion and tibial fracture repair procedures.

Infuse is a human bone protein that is applied to an absorbable collagen sponge carrier and is designed to stimulate bone growth.