OmniGuide Gets CE Mark Approval for Flexible CO2 Laser Fibers

OmniGuide Inc. of Cambridge, Mass., announced that TÜVRheinland, a provider of independent testing and certification services, has approved its products for CE Mark, a product safety certification system. This will make flexible fiber delivery of a CO2 laser for minimally invasive surgery available in Europe and other countries that accept the CE Mark, Omniguide said. Applications for the OmniGuide system include general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology and neurosurgery. It can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes. Until now, CO2 lasers have had limited applications for invasive surgery due to the absence of a fiber delivery system at their wavelength of operation, the company said. "The CE Mark approval of our flexible fiber delivery system for CO2 lasers is a significant step forward for our surgical business," said professor Yoel Fink, OmniGuide founder. Surgical cases will be performed initially by the Department of Otolaryngology at the CHUV Medical Center in Lausanne, Switzerland, OmniGuide said. The company's technology is based on a photonic bandgap fiber licensed from the Massachusetts Institute of Technology.