• OccuLogix (Toronto), which is developing rheopheresis, an advanced form of plasma therapy called membrane differential filtration, reported that the FDA has completed a review of the long-term efficacy in age-related macular degeneration (AMD) from rheopheresis in North America (LEARN) protocols and has given OccuLogix permission to initiate the studies. The company completed enrollment of 185 patients for participation in MIRA-1, its Phase III clinical trial using its RHEO system, which uses a pump to circulate blood through filters that remove unwanted proteins and other macromolecules from the plasma, to treat dry AMD. LEARN-1 is an open-label multicenter study that will enroll up to 120 subjects who have completed the treatment arm of the MIRA-1 study. There will be up to 12 investigational sites where the subjects will be randomized in a 1:1 fashion to receive either two or four RHEO Therapy booster procedures, and the results between the groups will be compared after three, six, nine and 12 months of follow-up from baseline. LEARN-2 is an open-label, multi-center study that will enroll up to 60 subjects who have completed the placebo arm of the MIRA-1 study.

• Triage Medical (Irvine, California) reported FDA clearance of its BONE-LOK products for spinal fixation. Initial indications for the device include degenerative disc disease, trauma and failed previous fusion. Triage's CLASP (Compression Locking Anchor with Secondary Purchase) technology is used in its BONE-LOK products for spinal fixation. The intended use of the 4.5 mm BONE-LOK Spinal Fixation device is as a transfacet pedicular screw for bilateral facet fixation, and can be used with or without bone graft, at single or multiple levels, in the lumbar spine. President Chip Stevens said, "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."