Frequently Asked Questions for Healthcare Professionals

The Yale Review Process & Medtronic's Perspective


What is Medtronic’s reaction to the findings in Yale’s review?
We’re pleased to have reached this milestone in the completion of the systematic reviews. The results add to a growing body of evidence regarding INFUSE® Bone Graft as a safe and effective treatment option in FDA-approved indications for use. Since it was FDA-approved in 2002, Medtronic has worked with the FDA to communicate the benefits and risks of INFUSE® Bone Graft so physicians have access to that important information in its labeling.

The systematic reviews considered multiple individual studies going back to 1996 and literature reports through 2012, each with different areas of focus, and combined these into two systematic reviews of the safety and effectiveness of rhBMP-2, including INFUSE® Bone Graft and investigational formulations. Medtronic reported complete adverse event information to the FDA during the IDE clinical trials, and that information appears in the product labeling for approved indication. As with all therapies and surgical procedures, INFUSE® Bone Graft poses certain risks that must be evaluated carefully by patients and physicians before use. Medtronic is committed to providing physicians with information that helps inform their medical decisions and choice of therapy for patients.

Why did Medtronic commission Yale to review the safety and effectiveness of INFUSE® Bone Graft?
In August 2011, as part of our commitment to patient safety and transparency and in response to questions raised about data included in peer-reviewed medical journals about INFUSE® Bone Graft, Medtronic commissioned Yale University to conduct a first-of-its-kind, independent review of data related to the safety and effectiveness of the product. Medtronic has long been an industry leader with respect to transparency, and the effort with Yale is yet another example of our commitment to data transparency and to providing clinicians with information that helps inform their medical decisions and choice of therapy for patients.

What information was provided to Yale for review?
Medtronic provided Yale with patient-level data from 17 of its completed spine clinical trials (INFUSE® Bone Graft and investigational product formulations not commercially available), as well as post-market medical device safety reports that were submitted to the FDA. The analyses also included data from published literature as late as 2012.

What additional data has come out since Medtronic provided its information to Yale?
Since York and OHSU obtained the data used in their analyses, several podium presentations and articles in peer-reviewed publications have added to the evidence around the safety and effectiveness of INFUSE® Bone Graft. The additional studies range in size and purpose and examine numerous topics addressed in the Yale review, including retrograde ejaculation and cancer. We believe the retrospective data published since August 2012, on the whole, continues to support that INFUSE® Bone Graft is a safe and effective treatment option when used in approved indications.

How was Yale selected for this review and what institutions did the analyses? Can you explain the process?
Medtronic commissioned Yale for this review based on its reputation as a respected academic institution with experience in data transparency efforts. Yale formed a steering committee that independently selected Oregon Health & Science University (OHSU) and University of York (York) in the UK to complete the analyses. Medtronic did not participate in the selection of the steering committee or research organizations.

No protocol was defined for the two review groups, allowing both York and OHSU to choose their own approaches (i.e., their own methodology) and the specific data they included. York and OHSU’s varying approaches and conclusions are a reflection of the complexity of the data and the different analytical approaches taken by York and OHSU. For additional information about how Yale selected the research organizations and their process for conducting the review, please contact Yale or visit their website, http://medicine.yale.edu/core/projects/yodap.

What was Medtronic's role in the analysis?
This was an independent review. Medtronic did not participate in the selection of the research organizations/steering committee, defining the methodology used, selecting the journal for publication or the timing of the data release. Medtronic clarified factual elements of its studies and answered product specific questions. For any questions that required Medtronic input throughout the reviews and the peer-review process of the journal, Yale managed communications directly with Medtronic. Medtronic did not have interaction during this process with OHSU or York and the authors had discretion as to whether or not to address or accept Medtronic's clarifications.

What did the $2.5 million grant to Yale cover?
The research grant provided by Medtronic to Yale covered the costs of the analyses, oversight, and operations of the systematic reviews and the data management program.

What happens with the data now that the analyses are complete? What is the plan for the Yale Open Data Access Program (YODA) website?
The YODA Project developed policies and procedures that will make available Medtronic’s clinical trial data related to recombinant human bone morphogenetic protein-2 (rhBMP-2). As listed on the YODA program website, the overall mission of the project is, “to promote open science, promote transparency, ensure good stewardship of clinical trial data, serve the needs of society and respect the legitimate concerns of industry.” Please refer to the Yale website for the specific details around the data management program – http://medicine.yale.edu/core/projects/yodap

What is the process for other researchers to access the data that was analyzed in the systematic analyses?
A detailed policy/process is listed on the YODA program website. As outlined in the policy, Yale will require registration for data access. This is consistent with the policies used by clinical trial research funders who make data available to external investigators, such as certain Institutes and Centers within the National Institutes of Health, who require registration for data access. Yale will oversee the data access program; Medtronic has no role in the registration process.

What is Medtronic's role in YODA?
Medtronic is the rightful owner of the clinical trial data and makes it available for external use. Medtronic has committed to support the data sharing effort, including the distribution of data, through calendar year 2013. Medtronic will not have a role in reviewing the registration or requests for access to data by researchers; Medtronic has granted the Yale team jurisdiction to determine who can receive the data. Medtronic will not have input into any publication that a researcher seeks to publish, however, abstracts and manuscripts resulting from the proposed research will be required to be submitted to Yale upon acceptance by a scientific research meeting or biomedical journal and Yale will share copies with Medtronic upon receipt.

Have other medical device companies engaged independent experts to review and provide their own conclusions on company-sponsored studies?
To our knowledge, this is the first time any medical device company has initiated this level of review and transparency of data for a medical device.

Does this review change the product’s indications?
No. The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device remains indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. Patients receiving the INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device. The INFUSE® Bone Graft with the LT-CAGE® Lumbar Tapered Fusion Device is to be implanted via an anterior open or an anterior laparoscopic approach. The INFUSE® Bone Graft with either the INTER FIX or the INTER FIX RP Threaded Titanium Fusion Device is to be implanted via an anterior open approach.

INFUSE® Bone Graft underwent FDA review and received approval for other uses in open tibial fractures and certain oral maxillofacial reconstruction procedures. For open tibial fracture applications, INFUSE® Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. The product must be applied within 14 days after the initial fracture and prospective patients must be skeletally mature. For oral maxillofacial procedures, 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 extractions sockets.

Additional guidance related to the parameters of the current indications may be found in the package insert included with the product or online at manuals.medtronic.com.

Product Safety


At a high level, what did Yale’s review conclude about the safety and effectiveness of INFUSE® Bone Graft?

The results of the two separate analyses add to a growing body of evidence regarding INFUSE® Bone Graft as a safe and effective treatment option in FDA-approved indications for use. Medtronic reported complete adverse event information to the FDA during the IDE clinical trials, and that information appears in the product labeling for approved indications. As with all therapies and surgical approaches, INFUSE® Bone Graft poses certain risks that must be evaluated carefully by patients and physicians before use. This review was independent, giving both York and OHSU the opportunity to choose the analytical approach they took and the specific data they elected to include.

Key elements of the two analyses:

Fusion rates – These analyses conclude equivalent or improved clinical outcomes compared to procedures requiring a second surgery to harvest bone (iliac crest bone graft (ICBG)). This is consistent with original clinical studies of INFUSE® Bone Graft, which were designed to show equivalence.

Adverse events – Medtronic reported complete adverse event information to the FDA during the IDE clinical trials, and that information appears in the product labeling for approved indications. As with all therapies and surgical procedures, INFUSE® Bone Graft poses certain risks that must be evaluated carefully by patients and physicians before use. Since approval of the product in 2002, Medtronic has worked with the FDA to communicate the benefits and risks of INFUSE® Bone Graft in its FDA-approved labeling. Both OHSU and York acknowledged Medtronic’s exhaustive reporting of adverse events from completed clinical trials to the FDA.

Cancer – The analyses conclude the rates of cancer in patients with either rhBMP-2 or hip graft were low (consistent with the expected incidence of similar age, gender, race in the general population) and the types of cancer were heterogeneous (diverse and unrelated to a specific type of cancer). Given Medtronic’s extensive pre-clinical studies of rhBMP-2, the totality of clinical trial evidence and retrospective analyses by other researchers on the occurrence of cancer in real-world use, we believe the data do not support a causal relation between INFUSE® Bone Graft and the development of cancer.

As specified in the labeling included with each INFUSE® Bone Graft kit, the product should not be used in patients suspected of having a malignancy at the site of application. Further, INFUSE® Bone Graft is contraindicated for use in the vicinity of a resected or extant tumor, in patients with any active malignancy, or patients undergoing treatment for a malignancy.

As part of our ongoing evaluation of this product, we have funded a retrospective analysis of a large, national payer database to investigate the incidence of cancer in real-world use of INFUSE® Bone Graft. This analysis has been accepted for presentation in the Fall of 2013. We are also planning a post-market surveillance registry to collect data from real-world use of the product.

Additionally, the majority of the data are from randomized controlled trials (RCTs) required for FDA approval. And as York stated in their report, "RCTs are unlikely to provide much information on rare or long-term adverse effects...."

OHSU stated in their report that, "MedWatch reports can be useful for identifying rare adverse events not described in cohort studies and RCTs. However, in our MedWatch analysis, we did not find new rare or alarming adverse events."

Pain Related to Outcomes – Several patient-reported outcome measurements provide insight regarding pain relief, including back and leg pain scores and Oswestry Disability Index (ODI) and Short-Form 36 (SF-36) questionnaires. York found statistically significantly better results for ODI, SF-36 PCS and back pain scores with INFUSE® Bone Graft. OHSU found statistical significance for ODI, SF-36 PCS and back pain score improvement for ALIF at 24 months.

Pain Related to Safety and Adverse Events – Both analyses reported an increased incidence of back and leg pain adverse events among patients who received rhBMP-2 during the early follow-up period (up to 4 weeks postoperatively). OHSU noted that for PL Fusion, these events are very heterogeneous (e.g., radiculopathy, Baker's cyst, sacroiliac joint pain, arthritic knee pain, ankle pain) and they may be unrelated to the fusion surgery. An assessment by the same researchers reveals no difference in the risk of possible radiculitis at 4 weeks and 24 months.

Retrograde Ejaculation (RE) – Neither group found a statistical difference between INFUSE® Bone Graft and ICBG, though they state that a potential increased risk exists. RE, sometimes mischaracterized as sterility, has been documented as a procedural risk in the product labeling since it was approved in 2002. It is well-documented in the literature that it is approach-related and associated with anterior surgical procedures. Since the Yale review began, independent researchers have conducted and published a number of studies based on their clinical experience that support these findings.

Adverse Events - Other – The analyses did not identify any new adverse event types.  Both OHSU and York acknowledged Medtronic’s exhaustive reporting of adverse events from completed clinical trials to the FDA. The following were identified as events of clinical interest.

Heterotopic Bone Formation – Our labeling clearly states that the potential for ectopic, heterotopic or undesirable exuberant bone formation exists. When INFUSE® Bone Graft was approved in 2002, Medtronic included this information in the FDA-approved labeling. The following warnings and precautions are listed in the labeling:

  • "The safety and effectiveness of the INFUSE® Bone Graft component with other spinal implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than anterior open (LT-CAGE®, INTER FIX, INTER FIX RP devices) or anterior laparoscopic (LT-CAGE® device) approaches have not been established."
  • "When degenerative disc disease was treated by a posterior lumber interbody fusion procedure with cylindrical threaded cages (INTER FIX devices), posterior bone formation was observed in some instances."
  • "Nerve compression associated with ectopic bone formation has been reported in patients undergoing spine surgery with rhBMP-2/ACS. Surgical intervention may be required to address the symptoms."
  • "The formation of exuberant or ectopic bone growth at the upper lumbar levels (L2-L4) may have a deleterious impact on certain neurovascular structures, e.g., the aorta and sympathetic nerve chain."
  • "The potential for ectopic, heterotopic or undesirable exuberant bone formation exists."

In addition to these warnings and precautions, “ectopic and/or exuberant bone formation” is listed as a potential adverse event in the labeling.*

Transient Bone Resorption – We have data on transient bone resorption (sometimes mischaracterized as osteolysis) included in our labeling under warnings and precautions:

  • "Inappropriate use of the product, such as preparing it differently than prescribed, compressing the rhBMP-2/ACS implant more than necessary, or overfilling the volume intended for new bone formation, may change the concentration of the rhBMP-2, which may inhibit the ability of the rhBMP-2/ACS to convert to bone and/or cause complications. Such use of the rhBMP-2/ACS implant may result in radiographic evidence of resorption, fluid formation, and/or edema. These findings may be asymptomatic or symptomatic."
  • "While there are currently anecdotal and literature evidence to suggest that volume overfilling and/or hyperconcentration of the rhBMP-2 solution may lead to fluid formation and/or edema, animal models for scientifically evaluating these events do not presently exist. A sheep model developed to test the hypothesis that volume overfilling and/or hyperconcentration of the rhBMP-2 solution results in radiographic evidence of bone resorption has preliminarily been evaluated and appears to be supportive of the hypothesized mechanism."
  • "Placement of rhBMP-2/ACS can cause initial resorption of trabecular bone that may be transient."
  • "Device migration has been reported with use of rhBMP-2/ACS in spinal fusion surgery. Device migration has been reported in the presence and absence of bone resorption."

In addition to these warnings and precautions, "disassembly, bending, breakage, loosening, and/or migration of components" is listed as a potential adverse event in the labeling.

Radiculitis – Regarding potential complications similar to radiculitis (i.e., radiating low back and leg pain), the following warning is listed in the labeling:

  • "Inappropriate use of the product, such as preparing it differently than prescribed, compressing the rhBMP-2/ACS implant more than necessary, or overfilling the volume intended for new bone formation, may change the concentration of the rhBMP-2, which may inhibit the ability of the rhBMP-2/ACS to convert to bone and/or cause complications. Such use of the rhBMP-2/ACS implant may result in radiographic evidence of resorption, fluid formation, and/or edema. These findings may be asymptomatic or symptomatic."
  • "The formation of fluid collections (sometimes encapsulated) in some cases resulted in nerve compression and pain, which may require clinical intervention (aspiration and/or surgical removal) if symptoms persist. Many of these reports have occurred when rhBMP-2/ACS was used in conjunction with unapproved approaches/devices or in a manner inconsistent with the instructions for use.”

In addition to this warning, “tissue or nerve damage,” “inflammation,” and “pain,” are listed as potential adverse events in the labeling.*

Dysphagia – Regarding potential cervical spine complications similar to dysphagia (i.e., difficulty swallowing), the following warning is listed in the labeling:*

  • "The safety and effectiveness of the INFUSE® Bone Graft component with other spinal implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than anterior open (LT-CAGE®, INTER FIX, INTER FIX RP devices) or anterior laparoscopic (LT-CAGE® device) approaches have not been established. When anterior cervical spinal fusions were performed using the INFUSE® Bone Graft component, some cases of edema have been reported within the first post-operative week. In some of these cases, this swelling has been severe enough to produce airway compromise, sometimes requiring emergency surgery." 

In addition to this warning, "development of respiratory problems" and "edema (swelling)," are listed as potential adverse events in the labeling.

What is Medtronic's reaction to the concerns surrounding cervical swelling mentioned in the report?
Use of rhBMP-2 in the cervical spine is not an approved indication. Cervical swelling is a known risk associated with all anterior surgical procedures in the neck. Further, it is also a known risk when INFUSE® Bone Graft is used in the anterior cervical spine, which has been stated in our labeling since 2005.

Additionally, Medtronic requested permission from the FDA to notify its spinal surgeon customers using INFUSE® Bone Graft of this safety risk in anterior cervical spinal fusions. The company mailed a "Dear Doctor" Letter in September 2004 to spine surgeons known to be using the product and the FDA approved the update to the package insert in early 2005. In 2008, the FDA issued a public health notification regarding the use of recombinant human bone morphogenetic proteins in the cervical spine.

Has Medtronic appropriately reported adverse events associated with rhBMP-2?
Yes. Medtronic reported complete adverse event information to the FDA during the IDE clinical trials, and that information appears in the product labeling for approved indications. Both OHSU and York acknowledged Medtronic’s exhaustive reporting of adverse events from completed clinical trials to the FDA.

How was the risk of cancer evaluated in the pivotal ALIF trial? What have you done to analyze the risk of cancer?
Mutagenicity and the potential impact on primary tumor cell growth in culture were evaluated in pre-clinical studies prior to the approval of INFUSE® Bone Graft, and there was no evidence to suggest concern. Additional in vivo studies in rats were conducted after INFUSE® Bone Graft was approved to assess the potential risk for growth and metastasis. Overall, these studies did not show an oncogenic or cancer-promoting effect of rhBMP-2.

Since there were no safety signals that warranted further study, cancer was not included as a pre-specified endpoint in subsequent studies. It is important to note that both analyses concluded the rates of cancer in patients with either rhBMP-2 or ICBG (control) were low and the types of cancer were heterogeneous. Again, while the analyses highlight questions that remain, these studies were not designed to collect information on cancer. Given Medtronic’s extensive pre-clinical studies of rhBMP-2, the totality of clinical trial evidence and retrospective analyses by the other researchers on the occurrence of cancer in real-world use, we believe the data do not support a causal relation between INFUSE® Bone Graft and the development of cancer.

Patient safety is a top priority, and in an effort to further understand possible cancer risks, Medtronic has funded a retrospective analysis of a large, national payer database to review the incidence of cancer in real-world use of INFUSE® Bone Graft. This analysis has been accepted for presentation in the Fall of 2013. Medtronic has also engaged cancer experts for their insights throughout the development of this product, and we will continue to do so as additional data and perspectives become available.

Trial Design


What is Medtronic’s response to allegations that INFUSE® Bone Graft clinical trials were poorly designed?

Clinical trial standards have evolved over time and criticism of trial design is based on today’s standards. INFUSE® Bone Graft trials were initiated prior to 2001 and conducted according to Investigational Device Exemption (IDE) regulations in order to gain FDA approval, with an intent to demonstrate equivalence to ICBG. All Medtronic INFUSE® Bone Graft trials were regulated by the FDA, with specific requirements for design, data collection and analysis. Because our trials were developed in overlapping periods of time, we applied consistent designs and methods for collecting AEs. ICBG was used as a comparator because it was and continues to be the gold standard graft material.  In 2001, at an FDA advisory panel, Medtronic was complimented for having well-designed trials in this new area of research.

Industry – Physician Collaboration


What is Medtronic doing to eliminate potential conflicts of interest?

At Medtronic, we believe that scientific and engineering collaboration between physicians and industry is vital to innovation and advancing patient care. Medtronic has led the industry in efforts designed to address potential conflicts of interest. We have implemented a number of important policies and procedures associated with collaboration and healthcare professionals.

Examples of our industry leadership include:

  • Medtronic has refined its clinical research policies, placing additional restrictions on participation of royalty earners in clinical studies. Our current policy restricts physicians from serving as investigators in pivotal clinical studies of any device on which they earn royalties. Royalty earning physicians may participate in early phase pilot or feasibility trials and/or regulatory required post-market surveillance studies (Section 522 studies) with appropriate institutional approvals (i.e., these physicians will be required to attest they conform to their institutional ethics committee policies regarding conflict of interest management).
  • Medtronic was one of the first medical device companies to voluntarily disclose consulting and royalty payments to physicians on our company website more than a year ahead of new disclosure requirements enacted as part of the Affordable Care Act/Sunshine Act.
  • We continue to collaborate with outside organizations such as AdvaMed to identify and adhere to appropriate industry standards. Additionally, we continue to press for widespread adherence to industry codes and best practices.

What is Medtronic’s response to allegations that paid consultants who conducted research on INFUSE® Bone Graft did not report serious side effects in their published journal articles?
Surgeon authors of medical journal articles, including those who published about INFUSE® Bone Graft, include discussion of adverse event information in their articles based on their view of what information is salient to the clinical application discussed in their own specific article. Detailed summaries of adverse event information regarding INFUSE® Bone Graft are readily accessible to all physicians in each box of INFUSE® Bone Graft. Given this context, it is common for surgeon authors to focus their discussion of adverse events on the information most relevant to the particular topics of their articles. Furthermore, that discussion of adverse events, along with the rest of the article, is evaluated and, if necessary, modified through the pre-publication peer-review process.

All of the articles criticized in The Spine Journal were published in top-tier medical journals and underwent detailed editorial review prior to publication.

Moreover, the overwhelming majority of the payments highlighted in The Spine Journal and elsewhere were contractually mandated, nondiscretionary royalty payments – most of which were for products entirely unrelated to INFUSE® Bone Graft. Further, the vast majority of the payments were received years after most of the articles were published.

Moving Forward with rhBMP-2


Will INFUSE® Bone Graft be available for use by physicians moving forward?

Yes. Medtronic continues to believe that INFUSE® Bone Graft’s benefit and risk profile makes it an important treatment option in FDA-approved indications for use.

What actions is Medtronic taking to address the questions that were raised in Yale's review?
Medtronic remains committed to ongoing monitoring of the long-term safety of INFUSE® Bone Graft. We use post-market surveillance to monitor the long-term outcomes of the product, and are planning a post-market surveillance registry to collect data from real-world use of the product. In addition, the company continues to work with the FDA to determine pathways for new indications for INFUSE® Bone Graft and for new rhBMP-2 products, including new formulations and carriers.

Patient safety is a top priority, and in an effort to further understand possible cancer risks, Medtronic has funded a retrospective analysis of a large, national payer database to review the incidence of cancer in real-world use of INFUSE® Bone Graft. This analysis has been accepted for presentation in the Fall of 2013.

Is Medtronic doing anything to ensure that researchers have access to all INFUSE® Bone Graft data, including results of clinical trials?
As part of this initiative, Medtronic has commissioned Yale to develop a novel program to provide researchers access to data on rhBMP-2 by means of a defined registration process and website. This planned program is unprecedented in the medical device industry and will differ from clinical trial publications or other data sources in that it will provide access to the full patient-level data sets assessed under Yale's oversight, including independent de-identified patient level data. This represents a novel approach as well as significant commitment to transparency and open-access to scientific research.

Does Medtronic plan to model the process they’ve taken with Yale and engage independent experts in an ongoing fashion?
Medtronic will evaluate whether to engage independent experts on a case-by-case basis. We have led the industry in implementing voluntary policies on physician collaboration and transparency, and we will continue to evaluate and follow these efforts closely as an important case study.

What is Medtronic's plan to expand the indications?
The company continues to work with the FDA and other regulators to determine pathways for new indications for INFUSE® Bone Graft and for new rhBMP-2 products, including new formulations and carriers.

What does this mean for AMPLIFY Matrix? Is there any update on that product’s status?
AMPLIFY Matrix is a different product from INFUSE® Bone Graft. It has unique characteristics including the carrier, rhBMP-2 dosage and concentration, and surgical indication and it has never been commercially available. The PMA for AMPLIFY lapsed on January 25, 2013 and the company continues to evaluate new indications for rhBMP-2 technologies, including products with new formulations and carriers.

What tools/resources are available to address patient, hospital, and payer questions?
A number of tools are available to physicians to support ongoing education about the use of INFUSE® Bone Graft. These tools help HCPs understand why INFUSE® Bone Graft is highly differentiated from other therapies and how to utilize the technology properly for its approved indications. For physicians who would like to obtain access to these educational materials, they may contact their sales representative. Alternatively, they may contact Medtronic at 901.396.3133 and ask to speak with a member of the INFUSE® Bone Graft biologics team.

Specific to the current issues addressed by Yale or raised in recent publications, Medtronic has developed educational material/brochures for customers. In these materials, customers will find information pertaining to INFUSE® Bone Graft and frequently asked questions surrounding the Yale review. Additionally, for physicians, Medtronic developed an in-depth series called Just the Facts that addresses safety concerns in a detailed fashion. A copy of these materials may be obtained through your local Medtronic sales representative. Physicians may also contact Medtronic at 901.396.3133 and ask to speak with a member of the biologics team. For the physician and patient brochures, physicians may either contact their local sales representative or the Medtronic offices.

Each of the above tools is based on data provided from the on-label clinical studies. For physicians requesting additional information, contact Medtronic’s Office of Medical Affairs at (800) 876-3133 ext: 6044.

Why should physicians continue to use INFUSE® Bone Graft?
INFUSE® Bone Graft continues to be a breakthrough therapy that has been utilized in over one million patients for more than ten years, and has stood the test of market adoption. With its decade of clinical application, rhBMP-2 has become one of the most extensively researched biologic agents commercially available today. INFUSE® Bone Graft achieves fusion for its indicated use and has a well-defined safety profile without the possible pain and complications associated with ICBG harvest procedures.

What is Medtronic's response to the conclusion in the systematic analyses specific to INFUSE® Bone Graft showing equivalence in fusion to ICBG?
The OHSU review found equivalent fusion rates and other clinical outcomes between INFUSE® Bone Graft and ICBG, which may be interpreted as negative. It is important to note that was the purpose of the original clinical trials of INFUSE® Bone Graft. The York review found increased fusion rates at 6-24 months with INFUSE® Bone Graft.

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