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INFUSE: Bone Morphogenic Protein

Study Shows Benefits of Medtronic’s INFUSE® Bone Graft in Dental Restoration
Data was Included in FDA Submission That Led to Approval of INFUSE for Certain Oral Procedures

TORONTO – OCTOBER 14, 2009 – Medtronic, Inc. (NYSE: MDT) today announced results of a study comparing the safety and effectiveness of INFUSE® Bone Graft to autogenous bone graft (bone harvested from the patient) when used in maxillary sinus floor augmentation.

 

Published in the September issue of the Journal of Oral and Maxillofacial Surgery, the INFUSE® Bone Graft Sinus Lift Augmentation Pivotal Study results were shared at the joint meeting of the American Academy of Oral and Maxillofacial Surgeons and Canadian Academy of Oral and Maxillofacial Surgeons in Toronto. These data were part of the pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA) that led to the March 2007 approval of INFUSE® Bone Graft in certain oral maxillofacial and dental regenerative uses.

INFUSE® Bone Graft was shown to have very similar rates of effectiveness to autogenous bone graft, the standard of care, for sinus lifts, which is a common dental surgical procedure. The advantage of using INFUSE® Bone Graft is that it avoids harvesting autogenous bone (bone from the patient) and the associated morbidity, cost, and increased surgical time.  The study provided actual human histological evidence that the bone generated by INFUSE® Bone Graft is normal, mature, 100-percent viable bone with no residual graft material, as evidenced by core samples taken at the time of dental implant placement.

"Investigators were unanimous in their support of the quantity, safety, and effectiveness of rhBMP-2 in inducing bone.  rhBMP-2 is an important alternative to autograft bone for those sinus lift augmentation patients with severe bone loss," said Gilbert Triplett, DDS PhD, Oral and Maxillofacial Surgery Chair at the Texas A&M Health Science Center in Dallas, Texas, and lead author of this publication.  “This device will be an outstanding addition to the armamentarium for bone graft augmentation in the oral environment.”

An estimated 15,000 U.S. oral maxillofacial surgeons, periodontists and other dental specialists treat patients with severe bone loss that results primarily from disease, trauma, or genetic defects.  Nearly 100,000 patients are indicated for a sinus lift augmentation to place dental implants. INFUSE® Bone Graft (rhBMP-2 combined with an absorbable collagen sponge) was originally approved for an anterior lumbar interbody fusion with a Medtronic titanium interbody fusion device in July 2002 and is also indicated for the treatment of acute open tibial fractures.  rhBMP-2 is a bone morphogenetic protein that stimulates the patient’s own stem cells to grow or regenerate their own new bone.  INFUSE® Bone Graft has received the prestigious Prix Galien USA 2008 Award for Best Biotechnology Product.

INFUSE® Bone Graft has not been tested in pregnant women to determine if it could pose harm to a developing fetus, nor has it been studied in nursing mothers.  Women of childbearing potential should not be treated with INFUSE® Bone Graft immediately prior to or during pregnancy, and should be advised not to become pregnant for one year following treatment. They should be warned of potential risks and should discuss other possible treatments with their doctor.  For important safety information, please go toTORONTO – OCTOBER 14, 2009 – Medtronic, Inc. (NYSE: MDT) today announced results of a study comparing the safety and effectiveness of INFUSE® Bone Graft to autogenous bone graft (bone harvested from the patient) when used in maxillary sinus floor augmentation. 
Published in the September issue of the Journal of Oral and Maxillofacial Surgery, the INFUSE® Bone Graft Sinus Lift Augmentation Pivotal Study results were shared at the joint meeting of the American Academy of Oral and Maxillofacial Surgeons and Canadian Academy of Oral and Maxillofacial Surgeons in Toronto. These data were part of the pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA) that led to the March 2007 approval of INFUSE® Bone Graft in certain oral maxillofacial and dental regenerative uses.
INFUSE® Bone Graft was shown to have very similar rates of effectiveness to autogenous bone graft, the standard of care, for sinus lifts, which is a common dental surgical procedure. The advantage of using INFUSE® Bone Graft is that it avoids harvesting autogenous bone (bone from the patient) and the associated morbidity, cost, and increased surgical time.  The study provided actual human histological evidence that the bone generated by INFUSE® Bone Graft is normal, mature, 100-percent viable bone with no residual graft material, as evidenced by core samples taken at the time of dental implant placement.
"Investigators were unanimous in their support of the quantity, safety, and effectiveness of rhBMP-2 in inducing bone.  rhBMP-2 is an important alternative to autograft bone for those sinus lift augmentation patients with severe bone loss," said Gilbert Triplett, DDS PhD, Oral and Maxillofacial Surgery Chair at the Texas A&M Health Science Center in Dallas, Texas, and lead author of this publication.  “This device will be an outstanding addition to the armamentarium for bone graft augmentation in the oral environment.”
An estimated 15,000 U.S. oral maxillofacial surgeons, periodontists and other dental specialists treat patients with severe bone loss that results primarily from disease, trauma, or genetic defects.  Nearly 100,000 patients are indicated for a sinus lift augmentation to place dental implants.
INFUSE® Bone Graft (rhBMP-2 combined with an absorbable collagen sponge) was originally approved for an anterior lumbar interbody fusion with a Medtronic titanium interbody fusion device in July 2002 and is also indicated for the treatment of acute open tibial fractures.  rhBMP-2 is a bone morphogenetic protein that stimulates the patient’s own stem cells to grow or regenerate their own new bone. 
INFUSE® Bone Graft has received the prestigious Prix Galien USA 2008 Award for Best Biotechnology Product.
INFUSE® Bone Graft has not been tested in pregnant women to determine if it could pose harm to a developing fetus, nor has it been studied in nursing mothers.  Women of childbearing potential should not be treated with INFUSE® Bone Graft immediately prior to or during pregnancy, and should be advised not to become pregnant for one year following treatment. They should be warned of potential risks and should discuss other possible treatments with their doctor.  For important safety information, please go to https://www.infusebonegraft.com/omf_indications.html