Triage Medical -R-, Inc. Receives FDA Clearance for Spinal Devices.IRVINE, Calif. -- Triage triage Division of patients for priority of care, usually into three categories: those who will not survive even with treatment; those who will survive without treatment; and those whose survival depends on treatment. Medical, Inc. today announced the receipt of 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. ") marketing clearance of its BONE-LOK(R) Products for Spinal Fixation. Initial indications for the device include 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). , trauma and failed previous fusion. Triage's patented CLASP(R) (Compression Locking Anchor with Secondary Purchase) Technology is utilized in the Company's BONE-LOK products for spinal fixation. Studies have shown CLASP Technology provides significantly greater compressive strength in fixating bone fractures than currently used devices. These studies also indicate that CLASP Technology provides this enhanced strength regardless of bone quality. To the Company's knowledge, no other fixation device can provide the strength of the CLASP Technology even in the presence of osteoporotic bone. Osteoporosis is a degenerative condition, usually associated with aging, which results in weak and/or brittle bone quality. The intended use of the 4.5mm BONE-LOK Spinal Fixation device A spinal fixation device is a rigid or semi-rigid mechanical support system which is surgically implanted into the vertebral column in order to obtain stabilization of spinal fractures, correction of spinal deformities, or treatment of degenerative spinal disease. is as a transfacet pedicular pedicular /pe·dic·u·lar/ (pe-dik´u-lar) pertaining to or caused by lice. pe·dic·u·lar adj. Of, relating to, or caused by lice. screw for bilateral facet fixation, and can be used with or without 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. , at single or multiple levels, in the lumbar spine Lumbar spine The segment of the human spine above the pelvis that is involved in low back pain. There are five vertebrae, or bones, in the lumbar spine. Mentioned in: Low Back Pain (ranging from L1 to S1). In addition, Triage intends to develop this technology for use as a posterior stabilization method in conjunction with anterior lumbar interbody fusions ("ALIFs"). Triage also is developing the Teleport(TM) Minimally Invasive Spinal Access Technology. Using the Teleport MIS System, the BONE-LOK devices provide spinal fixation as part of a minimally invasive spinal fusion spinal fusion n. A surgical procedure in which vertebrae are joined. Also called spondylosyndesis. Spinal fusion procedure. Commenting on the FDA clearance, Triage President Chip Stevens said: "Triage is very excited to bring CLASP Technology to spinal fixation. The benefits of CLASP Technology, including cost effectiveness, less invasive delivery and a tighter, more secure fixation with greater strength, will differentiate our BONE-LOK Spinal Fixation device from "traditional" posterior fixation devices. Triage is currently adapting these technologies to the cervical spine, as well as utilizing the core CLASP Technology in developing an innovative Spinal Dynamic Stabilization System." Triage Medical, Inc. is a closely held private company based in Irvine, California. Triage develops and markets products based upon CLASP Technology for a broad range of orthopedic applications. For additional information about Triage, please visit the Company's Web site at www.triagemed.com. |
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