MINNEAPOLIS--(BUSINESS WIRE)-- Following is a statement from Omar Ishrak, chairman and chief executive officer of Medtronic, Inc. (NYSE: 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.”
Additional company perspective is available here.
About INFUSE® Bone Graft (rhBMP-2)
INFUSE® Bone Graft is recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. The first FDA approval was received in 2002 and the product has been approved by the FDA for three indications.
In 2008 Medtronic’s INFUSE® Bone Graft received the Prix Galien USA 2008 Award for Best Biotechnology Product, considered the industry's highest accolade for pharmaceutical research and development.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
KEYWORDS: United States North America Minnesota
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Genetics Hospitals Medical Devices Pharmaceutical Manufacturing Engineering Research FDA Science