INFUSE BONE GRAFT CLINICAL EVIDENCE Bone Grafting (Oral Maxillofacial and Dental)
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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
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Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User:
) Registration. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. All information that you provide in connection with such registration must be complete, accurate, and truthful. The user name and password are personal to you and must not be shared with anyone else. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password.
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) Session Key. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. “Session Key” as used herein means a unique token active for a limited period of time generated by the Remote Viewer. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session.
) Logging of Session Activity. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America.
) Active Remote Users. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information.
) Availability. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
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Security/Privacy of Patient Data. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
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Clinical study information provides detailed data on the effectiveness of Infuse™ Bone Graft for oral-maxillofacial surgery. With more than a decade of clinical use, recombinant human bone morphogenetic protein 2 (rhBMP-2) has become one of the most extensively researched biologic agents commercially available today.
Infuse Bone Graft has over 10 years of approved market utilization and remains a safe and efficacious alternative to harvesting an individual’s own bone. Infuse Bone Graft has gone through the most stringent pathway for approval as a Class III Device with the U.S. Food and Drug Administration.
Infuse Bone Graft has a well-defined safety profile — without the possible pain and bone graft complications associated with bone harvest procedures.
Infuse Bone Graft was studied in a clinical program that included 312 patients who received either a sinus augmentation or localized alveolar ridge augmentation. In these investigational device exemption (IDE) clinical trials, the participants received either autograft or Infuse Bone Graft, and they were followed for an average of three to five years depending on the study.
The sinus augmentation clinical program included 220 patients enrolled in the sinus augmentation clinical program over four studies. This included:
The sinus augmentation studies demonstrated that Infuse Bone Graft consistently and predictably forms bone.4 Ninety-eight out of 99 patients in the sinus augmentation randomized controlled trials (RCTs) who received Infuse Bone Graft grew new, viable bone. The patient who did not grow bone had a chronic infection and failed a subsequent autografting procedure.
An average of 8.2 mm of mature, viable bone was induced with the use of Infuse Bone Graft, resulting in an average of 13.8 mm of total bone for implant placement. Patients received multiple implants per sinus, some of which were placed into sites with greater than 6mm of native bone due to anatomical configuration.
The localized alveolar ridge augmentation clinical program included three studies of 92 patients who had 50% or greater buccal wall defects in extraction sockets. The studies included:
Infuse Bone Graft generates new bone of adequate dimension that permits placement of dental implants that can be used to support fixed dental prostheses.
Bone core samples were taken at the time of dental implant placement in the RCTs. Core biopsies were acquired as early as six months post-Infuse Bone Graft placement and as late as 15 months. The bone formed in both the localized alveolar ridge augmentation and sinus augmentation studies was found to be similar. Infuse Bone Graft induces new, mature, viable bone with a rich vascular marrow space. Autogenous bone graft induced viable bone but the bone quality of the core samples was variable and included nonviable bone.
At the time of biopsy, the bone formed by Infuse Bone Graft was mature, primarily lamellar bone. Active remodeling was ongoing in the bone as it continued to grow and mature:
The multicenter, randomized human clinical trials for Infuse Bone Graft included a histological endpoint. When our investigators placed the dental implant, they took trephine core biopsies from each grafting site. Trephine core biopsies of Infuse Bone Graft and autogenous bone grafted sites were judged by independent reviewers to be equivalent: Bone grafts grew normal bone with little or no residual material, regardless of the procedure studied.
Density measurements were taken four months post-bone grafting and at six months post-implant placement. Comparing the control group (autograft) to the Infuse Bone Graft recipients, both groups had developed dense bone.
The results demonstrate that bone induced by Infuse Bone Graft responds as normal physiologic bone when loaded.
The primary effectiveness endpoint in the sinus augmentation IDE was to induce bone to successfully support implant-borne restoration after six months of functional loading. This endpoint was prospectively targeted at 73%, and was met—80% of the patients enrolled at 21 sites remain functionally loaded at six months, post-prosthesis placement.
The number of patients in the localized alveolar ridge augmentation study that had enough mature, viable bone induced for implant placement without augmentation was similar to the sinus augmentation study results (86%).
There was no significant difference in implant survival either by patient or by implant between the autograft and Infuse Bone Graft groups over two years post-prosthesis placement.
A total of 314 implants were placed in each group. The only failures that occurred during loading included:
INFUSE® Bone Graft is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.
The INFUSE® Bone Graft consists of two components–recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an absorbable collagen sponge (ACS). These components must be used as a system for the prescribed indication. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in the package insert.
INFUSE® Bone Graft is contraindicated for consumers with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in consumers with any active malignancy or consumers undergoing treatment for a malignancy, in pregnant women, or consumers with an active infection at the operative site.
There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of childbearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible dental treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of childbearing potential should be advised to not become pregnant for one year following treatment with this device.
INFUSE® Bone Graft has not been studied in consumers who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure).
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
An electronic version of the package insert may be found at
Fiorellini et al. Randomized Study Evaluating Recombinant Human Bone Morphogenetic Protein-2 for Extraction Socket Augmentation, Journal of Periodontology 76: 605-613, 2005
Triplett et al. Pivotal, Randomized, Parallel Evaluation of Recombinant Human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge and Autogenous Bone Graft for Maxillary Sinus Floor Augmentation, 2009 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 67:1947-1960, 2009
Data on File.
Boyne, P, De Novo Bone Induction by Human Bone Morphogenetic Protein-2 (rhBMP-2) in Maxillary Sinus Floor Augmentation, J Oral Maxillofacial Surgery 63: 1693-1707, 2005
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