The procedure is performed entirely through the nostrils using
a flexible balloon catheter designed to navigate through the complex
twists and turns of the sinus. The balloon is inflated to gently
restructure and widen the walls of the blocked passageway, allowing
the return of normal sinus functions.
Researchers in Melbourne have just completed a successful pilot
study of 10 patients at The Alfred to demonstrate the safety and
feasibility of the procedure. Significantly, the regulatory board
in the United States has recognized the results of this initial
trial and the new device has been approved in the US with Ear,
Nose and Throat (ENT) surgeons are now being trained in this technique.
The next phase of the trial, which will involve The Alfred Hospital
and six major US centers, will evaluate the outcomes of the procedure.
It will be performed on 50 Alfred patients who will be followed
up at two, 12 and 24 weeks after their surgery.
Principal researcher and Alfred ENT surgeon, Dr Christopher Brown,
said the surgery currently used to unblock sinuses sometimes resulted
in scarring and involved a greater risk of complications compared
to the Balloon Sinuplasty procedure.
“Because the brain is in close proximity to the sinuses,
there is potentially a risk of injury,” said Dr Brown.
“The frontal sinus in particular can be challenging
to many ENT surgeons and so any new developments are always welcomed.”
People involved in the trial have chronic sinusitis, however,
depending on the results of the trial, the procedure may prove
to be suitable for other sinusitis sufferers.
Sinusitis is very common. Health care experts estimate that 37
million Americans are affected by sinusitis every year. Health
care workers report 33 million cases of chronic sinusitis to the
U.S. Centers for Disease Control and Prevention annually. In Australia,
15 percent of the population suffers from sinusitis.