Recent Publication Shows Open Tibial Fracture Patients Have Improved Outcomes with Medtronic’s Infuse Bone Graft (rhBMP-2)
MEMPHIS, Tenn. – Sept. 11, 2006 – A recent article in The Journal of Bone and Joint Surgery (June 2006) shows that INFUSE® Bone Graft, recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) on an absorbable collagen sponge, helped patients with severe tibial (lower leg) trauma heal sooner and helped reduce the need for a follow-up bone graft to treat a delayed mending of the treated bones. Patients who received INFUSE Bone Graft also had a significantly lower rate of post-operative infection and were able to place load-bearing weight on their injured legs faster than those who did not receive INFUSE Bone Graft.
The findings of the publication were based on a large database of patients from 59 different trauma centers across 12 countries who participated in two prospective, randomized clinical trials of patients with open tibial fractures. Patients were randomized to either a control group consisting of the conventional treatment of intramedullary (IM) nail fixation, or the study group consisting of IM nail fixation with the inclusion of INFUSE Bone Graft during the surgical procedure. The results, which included one year follow-up, showed statistically significant reductions in the rate of infections and secondary interventions in Type-III tibial fractures.
Type-III open tibial fractures present a challenging situation for surgeons due to the high rate of complications associated with these fractures. The clinical benefits reported in this publication are consistent with previously reported data, which demonstrated significant cost savings to the healthcare system when INFUSE Bone Graft is used.
“These findings are straightforward,” said Thomas Einhorn, M.D., professor and chairman of the Department of Orthopaedic Surgery at Boston University. “These results show that the beneficial effects of rhBMP-2 are clearly evident in the most severe fracture types.”
INFUSE Bone Graft originally gained U.S. Food and Drug Administration (FDA) approval in 2002 for anterior lumbar interbody spine fusion procedures with specific spinal implant devices. In 2004, the FDA granted approval for the use of INFUSE Bone Graft in open tibial fractures treated with an IM nail within 14 days of the initial fracture. Since approval, it is estimated that INFUSE Bone Graft has been used on more than 250,000 patients. For more information on INFUSE Bone Graft, visit www.infusebonegraft.com.
More information on the article in The Journal of Bone and Joint Surgery is available at www.ejbjs.org.
About the Spinal Business at Medtronic
Medtronic’s spinal business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic’s spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
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 Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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