CAMBRIDGE, Mass., Aug. 4 OmniGuide, Inc., the developer ofthe first and only flexible CO2 laser scalpel, announced today the results ofa study comparing three treatment options -- external surgical excision,line-of-sight CO2 laser and the BeamPath(TM) flexible CO2 laser fiber. Thirtypediatric patients with an average age of three years underwent procedures toremove suprastomal tracheal fibromas in their windpipe. The study comparedoperating-room time, hospitalization time, need for follow-up procedures, andthe success rate of immediate post-operative removal of a tracheal tube, aprocess called decannulation. The study, led by Jerome Thompson, M.D., MBA,Chairman, Department of Otolaryngology, Head and Neck Surgery at University ofTennessee Health Science Center, was presented recently at the CombinedOtolaryngology Spring Meetings (COSM-2008) in Orlando, Fla.
"The pediatric suprastomal fibroma study demonstrated that the use of aflexible CO2 laser fiber improves quality of care and clinical outcomes onseveral levels," said Dr. Thompson. "The rate of immediate removal of thetracheal tube was four times greater in the flexible fiber group than theexternal excision group and two times greater than the line-of-sight CO2 lasergroup. Additionally, half of the patients who underwent treatment with thefiberoptic CO2 laser carrier had already undergone external excision prior andhad experienced recurrence. After then undergoing treatment with thefiberoptic CO2 laser fiber, three of the five patients had their tracheal tuberemoved immediately and did not experience recurrence of fibroma. Lastly,while the external excision patients are always monitored overnight in thehospital, the endoscopic procedures were performed on an outpatient basis andthe children were usually sent home after three to four hours."
Specific study results include:
-- Decreased Need for Follow-up Procedures -- 60 percent of patientstreated by external excision and 70 percent of patients treated with aline-of-sight CO2 laser required additional procedures to fully remove thelesion, compared with only 30 percent of patients treated with BeamPath fiber.Using the BeamPath, surgeons can reach deeper into the airway and more closelyapproximate tissue, allowing them to dissect fibroma from the tracheal wallmore easily. This feature is thought to reduce the need for furtherprocedures.
-- Increased Rate of Postoperative Decannulation -- When suprastomalfibroma is sufficiently removed, clinicians can proceed with postoperativedecannulation. 40 percent of patients treated with the BeamPath fiberproceeded to immediate postoperative decannulation compared with only 20percent of the line-of-sight CO2 laser and 10 percent of the external excisiontrial arms.
-- Hospitalization Time -- Patients treated with the BeamPath fiber andtraditional CO2 laser had similar postoperative hospital stays ofapproximately three to four hours, compared with 24 hours for externalexcisions procedures. Shorter procedure and hospitalization times translateinto reduced healthcare costs.
"Pediatric airway conditions present acute challenges to the surgeon dueto the fragile anatomy of the airway in children. Dr. Thompson's importantstudy establishes the superiority of OmniGuide's precision surgical fibers forthe treatment of suprastomal tracheal fibromas. We are working to ensure thatour precision fiber optic scalpels are available to pediatric surgeonsnationwide," said Yoel Fink, president and CEO of OmniGuide. "BeamPathprecision flexible CO2 laser fibers are enabling ENT surgeons to conduct newminimally-invasive procedures and helping improve the quality of healthcarefor patients."
About BeamPath(TM) Precision Optical Scalpels
Surgeons have used CO2 lasers for more than 30 years due to thehigh-degree of precision cutting capabilities. However, CO2 lasers werepreviously limited