Healthcare Industry News: cervical spine
News Release - October 9, 2006
Medtronic Receives FDA Approval to Study INFUSE Bone Graft in the Cervical SpineMEMPHIS, Tenn.--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) announced today that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to conduct a clinical trial to study INFUSE(r) Bone Graft in a cervical spinal fusion. The investigational device will consist of INFUSE Bone Graft inside a polyetheretherketone (PEEK) polymer interbody spacer used with an anterior cervical plate as a method of facilitating spinal fusion. The goal of the clinical trial is to evaluate whether INFUSE Bone Graft is a safe and effective alternative to traditional bone grafting techniques for cervical spine fusions.
In the United States, more than 200,000 individuals undergo spine fusions to treat degenerative changes in the cervical spine.
"The objective of this study is to demonstrate that INFUSE Bone Graft combined with a PEEK spacer and anterior cervical plate is a safe and proven treatment that induces reliable fusions," said Dr. Ken Burkus, a spine surgeon from Columbus, Ga. "Medtronic is putting a great amount of effort and investment into proving the safety and effectiveness of INFUSE Bone Graft throughout the spine."
INFUSE Bone Graft is a bone growth protein currently approved for use in an anterior lumbar interbody fusion (ALIF) procedure in combination with a metallic cage implant. The active ingredient in INFUSE Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2). The intent of this study is to expand the approved indications to include anterior cervical fusion procedures.
Patients and physicians can learn more about how INFUSE Bone Graft can be a viable and important therapy for patients with degenerative disc disease in the cervical spine at www.infusebonegraft.com.
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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