Balloon Sinuplasty Safe
sinuplasty technology used to treat patients who have chronic
sinusitis was found safe and highly effective in a multi-center study
with 24-week follow-up that was conducted last year.
presented at last year's annual American Academy of
Otolaryngology, Head and Neck Surgery showed 109 patients were
successfully treated with balloon
sinuplasty at nine medical centers.
Sinuses were consistently opened
and remained open during the study period.
new research confirms balloon sinuplasty technology is safe and
effective. In fact, patient quality-of-life scores showed a statistically
and clinically significant improvement throughout the 24-week
study period," says Howard Levine, M.D., director of the
Cleveland Nasal, Sinus and Sleep Center. "I've treated
more than 35 patients with these tools, and patients have consistently
healed quickly and reported excellent, sustained results."
year, more than 37 million Americans are affected by sinusitis.
Symptoms typically include headaches, nasal discharge, facial
pain and chronic obstruction. More than 350,000 patients a year
undergo surgical treatment for their chronic sinusitis problem.
In the surgical cases, Functional Endoscopic Sinus Surgery (abbreviated
FESS) uses a small endoscope so the surgeon can see inside the
nasal cavities. Specialized tools are then used to remove bone
and tissue in order to enlarge the sinus opening.
sinuplasty technology is a new tool set developed for sinus
surgeries. Similar in concept to catheters used in the heart
for balloon angioplasty, balloon sinuplasty devices can be threaded
into the sinus passageways and enlarged, widening the passages
in order to promote drainage and resolution of chronic sinusitis
symptoms. The technology can be used alone or with standard surgical
tools. Recovery times vary but patients typically return
to normal activities within 24-hours after their treatment.
date, more than 500 sinus surgeons have been trained to use the
ballon sinuplasty technique and more than 2,000 patients have
been treated across the United States.
is one of the most comprehensive studies ever conducted in sinus
surgery. We feel very confident in the data since 90 percent of
the patients enrolled returned for their six month follow up and
showed significant benefit and improvement," says Fred Kuhn,
M.D., founder of the Georgia Nasal & Sinus
Institute. "I consider balloon sinuplasty a major innovation
in sinus surgery since it provides patients and ENT surgeons with
an effective, minimally-invasive treatment option."
forms of chronic
sinusitis are related to obstruction of the sinus ostium which
is the area connecting the sinus to the nasal cavity. Normally,
the sinuses can produce up to a quart of mucous a day. However,
when blocked, the sinuses the sinuses cannot
drain properly and the retained fluids can become infected. Balloon
sinuplasty works by gently restructuring the bones
lining the sinus passageways, thus widening the opening and allowing
for normal drainage and functgion. Unlike traditional
approaches, this technology does not require the removal of bone
and tissue. As a result bleeding and pain, often associated with
sinus surgery, are drastically reduced.
a growing number of sinus conditions, this technology has changed
the way I approach cases," says
Ray Weiss, M.D., who has treated more than 100 patients with balloon
sinuplasty technology at the Sinus Center of the South in Biloxi,
Mississippi. "It wasn't designed to remove polyps or treat
ethmoid sinus disease. But for patients who have a chronic blocked
frontal, maxillary or sphenoid sinus, experience has shown this
is a fast, gentle way to treat the problem without the bleeding
and trauma associated with conventional cutting tools."
ten authors of this report, entitled "Safety and Efficacy
of Balloon Catheter Sinusotomy: A Multi-center 24 Week Analysis
in 115 Patients," are William
E. Bolger, M.D., from the Maryland Sinus Center, Bethesda, M.D.;
Christopher L. Brown, M.D., from the Sandringham District Memorial
Hospital, Bayside Network, Melbourne, Australia; Christopher A.
Church, M.D., at the Loma Linda University, Loma Linda, CA; Andrew
N. Goldberg, M.D., MSCE, at the University of California-San Francisco,
San Francisco, CA; Boris Karanfilov, M.D., Ohio Sinus Institute,
Columbus, OH; Frederick A. Kuhn, M.D., Georgia Nasal and Sinus
Institute, Savannah, GA; Howard L. Levine, M.D., Cleveland Nasal,
Sinus and Sleep Center, Cleveland, OH; Michael J. Sillers, M.D.,
Alabama Nasal and Sinus Center, Birmingham, AL; Winston C. Vaughan,
M.D., California Sinus Institute, Palo Alto, CA; and Raymond L.
Weiss, M.D., from the Sinus Center of the South, Biloxi, MS.
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