Artes Medical (San Diego), focused on aesthetic injectable products, has submitted the results of a five-year efficacy and safety study of ArteFill to the FDA in order, it said, to enhance product labeling. Artes says ArteFill is the first non-resorbable injectable filler for the correction of wrinkles known as smile lines or nasolabial folds, and was FDA-approved in October. The company recently completed a five-year follow-up study of 145 patients who were treated with ArteFill in the U.S. clinical trial when it secured FDA approval. In addition to demonstrating the safety profile of ArteFill, the study showed statistically significant (p < 0.001) improvement in patient wrinkle correction five years after the patient's last ArteFill treatment, and a statistically significant (p < 0.002) improvement in wrinkle correction at the five-year point compared to the six-month evaluation period.

• A study published in the March 15 issue of Spine shows that the majority of patients who were implanted with DePuy Spine's (Raynham, Massachusetts) Charite Artificial Disc by the study's author between 1989 and 1995 continue to have less pain and more mobility as much as 16 years after the procedure. The retrospective study examined the safety and effectiveness of the Charite Disc in 108 patients. The patients all had one-level lumbar degenerative disc disease and had failed non-operative treatment. Patients were followed for a minimum of 10 years and up to 16.8 years. The study reports that 87 (82.1%) patients experienced "excellent or good" clinical outcomes, prosthesis mobility was 90.6% and that nearly 90% of patients eligible to work before surgery returned to work, more than three-quarters to hard labor. The average range of motion (ROM) in flexion-extension was 10.1 degrees and lateral bending was 4.4 degrees. The Charite Artificial Disc was the first artificial disc approved by the FDA, the company said.