OmniGuide, a Cambridge, Mass.-based developer of flexible CO2 lasers, reported that is has received the European CE Mark for its products. 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, the company said.
According to OmniGuide, its flexible fiber CO2 laser system is indicated for multiple applications including the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, interventional radiology, and pulmonology. In addition, it can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.
The firm’s OmniGuide OtoBeam and BeamPath systems are U.S. Food and Drug Administration cleared.