Medtronic, Inc. today issued a press release in which it acknowledged the publication of the findings from Yale University’s third-party, independent review of INFUSE® Bone Graft. The press fluff is sounding pretty punchy, but observers are suggesting the report leaves the arguments for using the material looking a bit weak, performance seemingly no better than iliac crest grafts, yet with a small but attendant cancer risk.
INFUSE bone graft is a proprietary formulation of recombinant human bone morphogenetic protein-2 (rhBMP-2) that was FDA approved in 2002 for use in anterior lumbar interbody spine fusion to stimulate natural bone growth.
Yale University researchers were provided with patient-level data from 17 completed spine clinical trials conducted by Medtronic on INFUSE Bone Graft and investigational products with varying carriers, surgical approaches and concentrations of rhBMP-2 involving more than 2,000 patients.
A second thread of the analysis also included post-market adverse event (safety) reports that were submitted to FDA and data from published literature. Yale independently assembled a panel of experts and commissioned Oregon Health & Sciences University and University of York in the United Kingdom to conduct the analyses of the data.
Medtronic says the findings, published in the June 18 issue of the Annals of Internal Medicine add to a growing body of evidence regarding INFUSE Bone Graft as a safe and effective treatment option for patients in approved indications for use. The company’s press release can be found here.
Both analyses concluded that there are equivalent clinical success outcomes with INFUSE Bone Graft compared to iliac crest (hip) bone graft procedures. These findings are consistent with those in the original clinical studies of the INFUSE Bone Graft, which were designed to demonstrate the product is as effective as graft material harvested from a hip without the potential pain and complications associated with an iliac crest bone harvest procedure.
The part of the analysis that draws the eye though, is the identified cancer risk. According to the company, the risk is small and the data does not support a causal link. It is no doubt hoping that another retrospective analysis of a large real-world patient data set will support that conclusion when reported later this year.
“The complex analyses laid out in the systematic reviews add to a better understanding of the benefits and risks outlined in our labeling for INFUSE Bone Graft, which guides the safe and effective use of the product for patients in FDA-approved indications,” said Rick Kuntz, M.D., senior vice president and chief scientific, clinical and regulatory officer at Medtronic. “We are grateful to the participants of the reviews, which have taken patient-level data from multiple individual rhBMP-2 studies and literature reports, each with different areas of focus, and combined these into two systematic reviews of the safety and effectiveness of rhBMP-2. We will continue to conduct research on rhBMP-2 to further add to an increased understanding of the benefits and risks of this important treatment option.”
“We are pleased to have reached a milestone in completing this review as we move forward with this important treatment option,” said Chris O’Connell, executive vice president and president of Medtronic’s Restorative Therapies Group, including the Spine business. “We remain committed to INFUSE Bone Graft, which has a decade of clinical use and has been cited as one of the most important innovations in orthopedic medicine.”
Source: Medtronic, Inc.