• Artes Medical(San Diego) reported that it has begun qualification runs of its flagship product, ArteFill, at its newly completed commercial cGMP manufacturing facility in San Diego. ArteFill is a permanent injectable wrinkle filler used to correct naso-labial folds. The FDA approvable letter, received by Artes Medical in January 2004, required this milestone to be achieved in order to complete the full FDA approval process of ArteFill. Validation of the manufacturing processes for ArteFill and facilities inspection by the FDA are anticipated this summer. The company said it is preparing for final FDA approval in early fall.

• CryoPort Systems (Brea, California), a maker of temperature-sensitive, frozen packaging containers for shipping biological items, said its latest product offering, the Cryoporter L2N Dry-Shipper, is the only cryogenic L2N dry shipper in its class to hold certification from both the International Civil Aviation Organization and the International Air Transport Association. Companies using the Cryoporter are automatically qualified to safely ship diagnostic or infectious frozen specimens both domestically and internationally.

• Vivant Medical (Mountain View, California) reported findings from a clinical study using its VivaWave Microwave Ablation system were presented at the annual meeting of the American Hepato-Pancreato-Biliary Association (Los Angeles) in Fort Lauderdale, Florida. The company said the multi-center retrospective study represents the first report of a study of microwave ablation as the primary therapy in patients with hepatic malignancies. In the study, microwave ablation was used to treat 67 hepatic tumors in 20 subjects; a median of two tumors, with a median size of 3 cm, were treated in the study. Multiple types of microwave probes (surgical straight VivaTip, VivaRing Atom, and laparoscopic VivaTip) were used, depending on location and size. Total median ablation time for each patient was 10 minutes. In all cases, multiple ablations of hepatic lesions were performed simultaneously. In the abstract, Robert Martin, MD, assistant professor of surgery at the division of surgical oncology of the University of Louisville (Louisville, Kentucky), concludes, “Microwave ablation represents a faster and safer way to perform hepatic ablations in patients.”

• Whitney Blake (Bellows Falls, Vermont), a maker of retractile cords, custom cable and cable assemblies for high-flex applications, said it now is offering straight cable, coiled cords and high-performance flexible products that meet current environmental requirements.