FDA Approves INFUSE® Bone Graft for Use in Dentistry

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The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has recently granted approval to Medtronic Sofamor Danek to market INFUSE® Bone Graft for use in dental applications (see attachment). INFUSE® Bone Graft had been previously approved by the FDA as a replacement for autograft in spinal fusion procedures and for use in treatment of open tibia fractures.

FDA approval of INFUSE marks a major step forward in the future of implant dentistry

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has recently granted approval to Medtronic Sofamor Danek to market INFUSE® Bone Graft for use in dental applications (see attachment). INFUSE® Bone Graft had been previously approved by the FDA as a replacement for autograft in spinal fusion procedures and for use in treatment of open tibia fractures.

"FDA approval of INFUSE marks a major step forward in the future of implant dentistry" comments Dr. Andrei Mark of Central Park Oral Surgery in New York City. Dr. Mark, who was recently featured on the cover of Doctor of Dentistry -- NYC edition, was one of the first dentists locally to incorporate off-label use of INFUSE in implant dentistry with remarkable results. The outcome of one of his most recent patient cases will appear in the Dental Case Studies column written by Dr. Mark in the upcoming May/June issue of the New York City edition of Doctor of Dentistry magazine.

Commenting on the potential use of INFUSE in implant dentistry Dr. Mark went on to say, "the accelerated bone growth promoted by this morphogenetic protein-2 will enable patients who were previously poor candidates for dental implants to revisit this procedure as a more permanent means to help restore their natural bite characteristics."

Medtronic Sofamor Danek is a global leader in medical technology with the goal of alleviating pain, restoring health and extending life for millions of people around the world. For additional information on INFUSE Bone Graft visit infusebonegraft.com or call 1-800-468-9730. For information regarding dental case studies involving the use of INFUSE in implant dentistry contact: Jeff Corkill, public relations director at Central Park Oral Surgery, (212) 813-0707, (212) 813-0808 (fax).

Doctor of Dentistry is the business and lifestyle magazine for dentists published nationally by Sunshine Media, Inc. For more information on the NYC edition of Doctor of Dentistry, contact: Henry Collins, publisher: (347) 431-5803, (314) 431-5803 (fax).

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