JERICHO, N.Y., Nov. 16, 2010 /PRNewswire/ — Following results
of its 12 month study in Europe, Spatz FGIA, Inc. has
received regulatory approval for extension of the implantation
period from six months to 12 months. Intragastric balloons for
weight loss have been used successfully for the last 17 years
outside of the US, however, the risk of balloon deflation with
subsequent bowel obstruction has mandated removal of all
intragastric balloons at six months. The unique anchoring system of
the Spatz device protects a deflated balloon from advancing into
the intestines, allowing it to be used safely beyond six
months.
“While we welcome this extraordinary news, extending the
implantation time alone is not enough to produce greater weight
loss. Non-adjustable balloons lose their effect within 2 to 4
months, so additional implantation time is not likely to increase
weight loss significantly,” said Dr. Jeffrey Brooks, founder and
CEO of Spatz. “Only an adjustable balloon can offer repeated
waves of weight loss, after the balloon volume is adjusted upward,”
he continued.
The European study has reported an additional 8 kg (17.6 lbs)
weight loss following adjustments. In addition, intolerant patients
have been successfully adjusted downward, with continued weight
loss. Adjustments plus extended implantations have resulted in an
average weight loss of 35.5 kg (78 lbs) at the end of one year
– achieving loss of 67% of their excess weight. “The potent
combination of adjustability and one year implantation is unique to
the Spatz device, and will open up a new era in endoscopic weight
management,” continued Brooks.
“Our gastric balloon specialists have requested adjustability
and longer implantation time- and we can now deliver this unique
combination,” said David Hofstadter, Director of Marketing and
Business Development. “We have been overwhelmed with requests from
every corner of the planet,” he continued, “and we intend to make
this
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