Interpore Cross International announced that the U.S. Food and Drug Administration (FDA) has granted it 510(k) clearance to market the Altiusâ Occipito-Cervico-Thoracic (OCT) System implant. This system is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction affected by degenerative conditions, deformity, trauma and tumors. Based on industry reports, the Company estimates the current U.S. market for this product is approximately $40 million annually.
Joseph A. Mussey, President and Chief Operating Officer said, "Complementing our C-Tekâ Cervical Plate System, which is used in anterior applications, the Altius system is our first device cleared for the posterior cervical spine. This new clearance expands our product offering in the spinal implant category and gives us the opportunity to participate in a part of the cervical spine surgery market we were not addressing before. Altius' unique screw-connector design facilitates ease of surgical implantation in basic single level fusions as well as in complex occipito-cervico-thoracic fusions. We anticipate Altius will be introduced to the market during the first half of 2003."
The Altius system is intended for use in the posterior portion of the cervical spine (neck) for a variety of spinal indications, including degenerative disc disease, fracture, dislocation, revision of previous cervical spine surgery, and tumors.