Studies have shown CLASP Technology provides significantly greater compressive strength in bone fixation 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 3.8mm CS Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Compression Device is indicated for bilateral facet fixation, with or without bone graft, at a single or multiple levels from C2 to S1.
TELEPORT(TM) Spinal Access Technology
Triage has also developed the TELEPORT Spinal Access Technology. Using the TELEPORT System, the 3.8mm CS Compression Devices provide spinal fixation as part of a minimally invasive spinal fusion procedure. Therefore, when used in combination with the TELEPORT System, the CS Compression Devices can be implanted posteriorly in the cervical and lumbar spine in a percutaneous procedure requiring only a very small surgical incision.
Commenting on the FDA clearance, Triage President and COO Chip Stevens, said: "Triage is very excited to bring this additional technology to our current spinal fixation products. The benefits of CLASP Technology, including cost-effectiveness, less invasive delivery and a tighter, more secure fixation with greater strength, will differentiate our CS Compression Device from 'traditional' posterior fixation devices."
Triage Medical Inc. is a closely held private company based in Irvine. 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.