Invendo demonstrates sedationless colonoscopy
6 June 2007
Munich, Germany. invendo medical GmbH demonstrated a live
screening colonoscopy using its sedation-free colonoscope, the invendoscope,
in Berlin in May.
The examination was performed by Professor Thomas Rösch (Charite, Berlin
University Hospitals) in the Sana Klinikum Lichtenberg (Oskar-Ziethen
Hospital) on a 50-year old unsedated patient. The single-use colonoscope,
the invendoscope SC40, was shown to an audience of about 500 physicians.
The invendoscope SC40 is CE-marked and hence approved for sale in Europe,
with market launch expected in 2008.
also presented clinical data from a pilot study of the invendoscope in a
poster session at Digestive Disease Week 2007 in Washington.
The pilot study was a proof-of-principle study on 28 asymptomatic paid
volunteers (12 males, 16 females, mean age 48 years, range 23-68 years), who
consented to undergo sedation-free total colonoscopy with the new invendo
medical device. The study was approved by the Charité Ethical Committee and
University of Frankfurt Ethical Committee.
“Our pilot study with invendo’s
new colonoscope — the invendoscope SC40 — was performed without pain in 92%
of the cases. No sedation was given to any patient, and no complications
occurred,” said Prof. Rösch, who is Chief of Endoscopy at Charité University
Hospitals Berlin (Germany).
“These data are very exciting, because this new technology has the
potential to significantly advance the acceptance of patients who should
have colonoscopy but are afraid to do so, because they fear pain and have to
be sedated. While further research is needed, of course, to determine if the
invendo device will best serve the goal of a simple, pain-free, sedationless
and accurate colonoscopy, nevertheless these early data are very
“Colon cancer has the second-highest incidence of cancers
worldwide. It can be beaten if diagnosed early. Unfortunately, while
colonoscopy is the undisputed gold standard for diagnosis of colon cancer,
it has very low acceptance by patients. Indeed, only a relatively small
percentage of the eligible population worldwide undergoes colon cancer
screening. Given the dire need for improved acceptance by potential
screenees, we are extremely pleased with the results of this pilot study,”
said Konstantin Bob, M.D., Chief Technical Officer and Co-Founder of invendo
“There are several reasons for lack of acceptance of colon cancer
screening, but certainly the pain associated with conventional colonoscopy
and the subsequent need for sedation are what keep a majority of eligible
patients from being screened. We therefore believe that our new device might
play a major role in significantly increasing the number of persons who will
undergo a colonoscopy.”