INFUSE Moves into Dental
BY JOHN CHOPACK, NOVEMBER 10, 2006
Medtronic, Inc. announced yesterday that the FDA Dental Products Advisory Panel had unanimously voted to recommend approval of INFUSE Bone Graft for certain oral and maxillofacial procedures. If the FDA agrees with that panel's recommendation, the US indications for INFUSE Bone Graft will be expanded to include certain dental procedures. Although no details were disclosed, we assume that many of these procedures will include improving bone viability for dental implant procedures.
Traditionally, dental specialists have had to harvest bone from other portions of the patient's body, including the iliac crest, for transplantion to the mouth. This causes unnecessary pain due to donor site morbidity and dramatically increases both the surgical time and infection risk. The use of INFUSE has the potential to reduce surgical time and infection risk while eliminating donor-site pain. These benefits have the potential to significantly increase the number of dental implant procedures in the U.S.
The PMA submission included a prospective, randomized clinical trial which included 312 patients who were evaluated for a period of 36 months. Evaluations took place at the time of the bone grafting, dental implant and prosthesis placement and longer term functional loading of the dental implants. The study hit its primary endpoint of functional dental implant loading, which was determined by the ability to chew.
This recommendation for approval for dental procedures represents the third approval for INFUSE in the U.S. The first two approvals were for spinal fusion procedures and specific trauma applications.
