The BeamPath(TM) CO2 Laser Fiber was used to resect obstructive airway fibromas in children and was compared to an open surgical modality, as well as to "line-of-sight" articulated-arm CO2 lasers. Results show significant reduction in hospital stay vs. open excision and fewer follow-up procedures vs. the line-of-sight CO2 laser system. CAMBRIDGE, Mass., Aug. 4
CAMBRIDGE, Mass., Aug. 4 /PRNewswire/ -- OmniGuide, Inc., the developer of
the first and only flexible CO2 laser scalpel, announced today the results of
a study comparing three treatment options -- external surgical excision,
line-of-sight CO2 laser and the BeamPath(TM) flexible CO2 laser fiber. Thirty
pediatric patients with an average age of three years underwent procedures to
remove suprastomal tracheal fibromas in their windpipe. The study compared
operating-room time, hospitalization time, need for follow-up procedures, and
the success rate of immediate post-operative removal of a tracheal tube, a
process called decannulation. The study, led by Jerome Thompson, M.D., MBA,
Chairman, Department of Otolaryngology, Head and Neck Surgery at University of
Tennessee Health Science Center, was presented recently at the Combined
Otolaryngology Spring Meetings (COSM-2008) in Orlando, Fla.
"The pediatric suprastomal fibroma study demonstrated that the use of a
flexible CO2 laser fiber improves quality of care and clinical outcomes on
several levels," said Dr. Thompson. "The rate of immediate removal of the
tracheal tube was four times greater in the flexible fiber group than the
external excision group and two times greater than the line-of-sight CO2 laser
group. Additionally, half of the patients who underwent treatment with the
fiberoptic CO2 laser carrier had already undergone external excision prior and
had experienced recurrence. After then undergoing treatment with the
fiberoptic CO2 laser fiber, three of the five patients had their tracheal tube
removed immediately and did not experience recurrence of fibroma. Lastly,
while the external excision patients are always monitored overnight in the
hospital, the endoscopic procedures were performed on an outpatient basis and
the children were usually sent home after three to four hours."
Specific study results include:
-- Decreased Need for Follow-up Procedures -- 60 percent of patients
treated by external excision and 70 percent of patients treated with a
line-of-sight CO2 laser required additional procedures to fully remove the
lesion, compared with only 30 percent of patients treated with BeamPath fiber.
Using the BeamPath, surgeons can reach deeper into the airway and more closely
approximate tissue, allowing them to dissect fibroma from the tracheal wall
more easily. This feature is thought to reduce the need for further
procedures.
-- Increased Rate of Postoperative Decannulation -- When suprastomal
fibroma is sufficiently removed, clinicians can proceed with postoperative
decannulation. 40 percent of patients treated with the BeamPath fiber
proceeded to immediate postoperative decannulation compared with only 20
percent of the line-of-sight CO2 laser and 10 percent of the external excision
trial arms.
-- Hospitalization Time -- Patients treated with the BeamPath fiber and
traditional CO2 laser had similar postoperative hospital stays of
approximately three to four hours, compared with 24 hours for external
excisions procedures. Shorter procedure and hospitalization times translate
into reduced healthcare costs.
"Pediatric airway conditions present acute challenges to the surgeon due
to the fragile anatomy of the airway in children. Dr. Thompson's important
study establishes the superiority of OmniGuide's precision surgical fibers for
the treatment of suprastomal tracheal fibromas. We are working to ensure that
our precision fiber optic scalpels are available to pediatric surgeons
nationwide," said Yoel Fink, president and CEO of OmniGuide. "BeamPath
precision flexible CO2 laser fibers are enabling ENT surgeons to conduct new
minimally-invasive procedures and helping improve the quality of healthcare
for patients."
About BeamPath(TM) Precision Optical Scalpels
Surgeons have used CO2 lasers for more than 30 years due to the
high-degree of precision cutting capabilities. However, CO2 lasers were
previously limited to "line-of-sight" procedures with no flexible delivery
system available. OmniGuide's BeamPath fiber is based on breakthrough fiber
technology developed at MIT, published in Nature and Science magazines. This
technology has enabled OmniGuide to manufacture the world's first flexible
fibers for CO2 laser surgery. BeamPath fibers empower surgeons to perform
delicate cutting and coagulation with minimal thermal tissue damage and
maneuverability, a major advantage over traditional line-of-sight CO2 lasers.
Since their initial launch, BeamPath fibers have been used successfully in
more than 4,000 surgical procedures in the fields of Laryngology, Head & Neck
Surgery, Otology, Gynecology, Neurosurgery and Spine Surgery.
About OmniGuide, Inc.
OmniGuide, Inc., is the worldwide leader in precision optical scalpels for
minimally invasive surgery. OmniGuide CO2 laser fibers are clinically targeted
disposable optical scalpels optimized for specific surgical procedures. The
company 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
currently distributes its products in the U.S. and Europe. OmniGuide is
committed to developing products that improve and expand surgical treatment
options, enhance clinical outcomes, and reduce treatment complexity and cost.
Additional information about OmniGuide can be found at
http://www.omni-guide.com
Contacts: Dana Conti or Lori Stein
Schwartz Communications
(781) 684-0770
OmniGuide@schwartz-pr.com
SOURCE OmniGuide, Inc.
