Medtronic Receives FDA Approval to Study INFUSE Bone Graft in the Cervical Spine.MEMPHIS Memphis, city, ancient Egypt Memphis (mĕm`fĭs), ancient city of Egypt, capital of the Old Kingdom (c.3100–c.2258 B.C.), at the apex of the Nile delta and 12 mi (18 km) from Cairo. , Tenn. -- Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ) announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted an investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) to conduct a clinical trial to study INFUSE(r) Bone Graft bone graft Orthopedic surgery Sterilized bony tissue, often of cadaveric origin, used to fill and/or 'sculpt' bone defects Indications Spinal fusion, revision of failed articular prostheses, filling traumatic or malignant bone defects, or periodontal defects. in a cervical spinal fusion spinal fusion n. A surgical procedure in which vertebrae are joined. Also called spondylosyndesis. 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 morphogenetic /mor·pho·ge·net·ic/ (mor?fo-je-net´ik) producing growth; producing form or shape. 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 Degeneration of the intervertebral disc, which is often called "degenerative disc disease" (DDD) of the spine, is a common disorder of the lower spine and for some people can cause low back pain and/or leg pain (sciatica). 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. About Medtronic 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion