OmniGuide announced new clinical study results which demonstrate the safety and efficacy of its handheld fiber for CO2 laser stapedotomy compared to the handheld KTP laser, and the availability of two next generation products for otology. OmniGuide will be showcasing its new BeamPath® OTO products featuring compact and versatile fiber and handpiece designs based on breakthrough technology and discussing the results of the latest stapedotomy study by Vincent R et al. in booth 515 at the Combined Otolaryngology Spring Meetings (COSM) in Paris/Bally's Las Vegas from April 28 - May 2.
"The important results emanating from this independent clinical study serve to validate the clear benefits of our hand held CO2 laser scalpels for otologic surgery," said Yoel Fink, CEO, OmniGuide. "The superior outcomes established in this study, suggest that OmniGuide's technology should be seriously considered for otologic surgeries where precision and minimal trauma is required."
According to the Center for Disease Control (CDC), hearing loss affects 36 million people in the US and is often due to fixation of the vibrating bones that conduct sound in the middle ear a specific condition called otosclerosis. The surgical procedure to repair hearing loss due to otosclerosis is stapes surgery and lasers are used to precisely cut and manipulate the miniscule bones of the ear to restore hearing. Currently, there are several types of lasers used for stapes surgery, and two of the most frequently used are the handheld KTP laser and the handheld CO2 laser. These lasers are very different in the way they interact with tissue but are used to serve the same purpose and, until recently, had never been compared equally.
Dr. Robert Vincent from the Causse Ear Clinic in Beziers, France published a prospective clinical study in The Laryngoscope Journal (March, 2010) comparing the handheld KTP and CO2 lasers for primary stapes surgery. The clinical study included 214 patients, treated between January 2008 and January 2009, and is the first to show improvement in hearing results using the OmniGuide hand-held CO2 laser for otology. Specifically, the success rate in the CO2 laser group was 97% and in the KTP laser group was 92%. Also, patients' high frequency hearing results using the CO2 laser were improved over those of the KTP laser group with statistical significance. All patients were treated by the same surgeon using the same technique.
"When I was first introduced to OmniGuide and its CO2 laser I was not very convinced. I had been using the KTP laser in procedures for 17 years and was very pleased with it and the results," said Dr. Robert Vincent, Causse Ear Clinic. "I was intrigued and surprised by the outcomes of my clinical study and the improvements in outcomes using the CO2 laser compared to the KTP laser. I have turned progressively to the CO2 laser since my experience with OmniGuide."
The new BeamPath® OTO-S Fiber, designed for precise stapes surgery, and the new BeamPath® OTO-M Fiber, designed for complex chronic ear and tumor surgery, are the third generation of BeamPath® OTO products developed by OmniGuide in the past three years. Both new otology fiber products, available since March 2010, feature an enhanced tip design and versatile, indication-specific power handling capabilities. The new fibers also feature very small tip designs to enhance visualization, provide versatility and precise power delivery, and are 20 centimeters longer than previous versions.
About OmniGuide, Inc.
OmniGuide, Inc., is the worldwide leader in precision optical scalpels for minimally invasive surgery. OmniGuide CO2 laser fiber products are clinically targeted disposable optical scalpels optimized for specific surgical procedures. The Company has recently introduced a line of fiber-enabled, portable, low-cost CO2 lasers for use in operating rooms and surgical suites. The Company designs and manufactures its fiber products in Cambridge, Mass. based on multi-material photonic bandgap fiber technology exclusively licensed from MIT. The Company distributes its products in the U.S. through a direct sales force and in Europe through distribution partners. OmniGuide is committed to developing products that improve and expand surgical treatment options, enhance clinical outcomes, and reduce treatment complexity and cost.
OmniGuide has several leading-edge flexible laser fiber scalpels for use in both hospital and office settings; leading brands include the BeamPath™ ENT for laryngology, airway and head and neck procedures and BeamPath™ OTO for otology procedures and the BeamPath™ NEURO for neurosurgery.
Source: OmniGuide, Inc