• Artes Medical (San Diego) reported its first shipment of ArteFill to trained physicians. Artes says that ArteFill is "the first and only non-resorbable injectable filler for the correction of wrinkles, or nasolabial folds and featuring the use of microspheres that are not absorbed by the body and therefore providing permanent support for long-lasting wrinkle correction in one to two treatments. ArteFill was approved by the FDA in October 2006 based on data from a 12-month controlled, randomized, double-masked, multi-center U.S. clinical trial, which compared outcomes for patients treated with ArteFill with those of patients treated with the leading bovine collagen-based filler. At the 6-month evaluation, which was the primary efficacy evaluation period for the clinical trial, the wrinkle correction in patients treated with ArteFill persisted and showed statistically significant improvement compared to the wrinkle correction in the patients treated with the collagen control, who returned to their pretreatment status. The ArteFill patients were also evaluated one year after treatment, demonstrating continued safety and wrinkle correction.

• AtriCure (West Chester, Ohio) reported receiving FDA 510(k) clearance for its Isolator Synergy Bipolar Ablation System for the ablation of soft tissue. The device is not yet cleared for the ablation of cardiac tissue. The system incorporates two pulsing pairs of electrodes in the jaws of the clamp, which the company believes will allow physicians to ensure full thickness ablation of thicker and more diseased tissues and create more durable lines of block. Pre-clinical studies using the system have demonstrated that the lesions are shaped like columns for durability and that the ablation lines are consistently transmural in thicker tissues, which the company believes will result in superior patient outcomes. AtriCure is a manufacturer of surgical devices.

• Generic Medical Devices (Gig Harbor, Washington) reported CE-marking and a EC-Declaration of Conformity (EC-DoC) indicating compliance with health and safety requirements set out in applicable European Directives and allowing the company to place the GMD universal circumcision clamp on the market in all European Union countries, as well as other countries that accept this certification. In January, GMD reported FDA 510(k) clearance to market the circumcision clamp. The GMD Universal Circumcision Clamp is a medical device intended for use in circumcision procedures generally performed on newborns and less frequently on older males. Generic Medical makes surgical devices marketed, it says, "at generic prices."