Medtronic acknowledged the publication of the findings from Yale University's third-party, independent review of INFUSE R Bone Graft, a proprietary formulation of recombinant human bone morphogenetic protein-2 ,rhBMP-2, that was approved by the U.S. Food and Drug Administration, FDA, in 2002 for use in anterior lumbar interbody spine fusion to stimulate natural bone growth. Since it was approved, Medtronic has worked with the FDA to communicate the benefits and risks of the product in its FDA-approved labeling. 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 findings reiterate, as with all therapies and surgical procedures, INFUSE Bone Graft poses certain risks that must be evaluated carefully by patients and physicians before use. "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," said Rick Kuntz, senior VP and chief scientific, clinical and regulatory officer at Medtronic.
- Health Care Industry