Medtronic CEO Omar Ishrak Statement on rhBMP-2 Articles in Spine Journal

Following is a statement from Omar Ishrak, chairman and chief executive officer of Medtronic, Inc. MDT on a series of articles on recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) published in a recent edition of Spine Journal. “Integrity and patient safety are my highest priorities. While the Spine Journal articles raise questions about researchers' conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold. “Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications. We remain committed to ongoing study of the safety and efficacy of rhBMP-2, especially in applications not covered by FDA labeling. “For several years Medtronic has been leading the industry in reforms designed to eliminate or mitigate conflicts of interest. We will continue to investigate questions surrounding researchers' potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices.”