SUNNYVALE, CA--(Marketwire - March 16, 2010) - Avantis Medical Systems, Inc., a technology
leader in developing novel catheter-mounted digital imaging devices, today
announced the publication of two large clinical studies demonstrating that
the Third Eye® Retroscope® helps physicians find more pre-cancerous
polyps in the colon. Both studies were published in the March 2010 issue
of Gastrointestinal Endoscopy, the leading journal for gastroenterologists,
colorectal surgeons and other physicians who perform colonoscopy.
The Third Eye Retroscope is a catheter-based camera that is inserted
through the instrument channel of a standard colonoscope to provide the
physician with a retrograde (backward) view of the lining of the colon.
This retrograde view can reveal lesions that are hidden behind folds where
they can't be seen with the colonoscope's forward view alone.
The first study was led by Dr. Jerome D. Waye, Clinical Professor of
Medicine at Mount Sinai School of Medicine, New York, NY. Titled "A
Retrograde-Viewing Device Improves Detection of Adenomas in the Colon: A
Prospective Efficacy Evaluation," the study involved 14 investigators and
249 patients at 8 medical centers in the U.S.(1) The investigators found
that the Third Eye improved detection and removal of polyps by 13.2%
compared to the colonoscope alone. For adenomas, the polyps that are most
likely to become cancers over time, the additional detection rate with the
Third Eye was 11.0% for lesions of all sizes.
For medium-size adenomas (at least 6 mm in diameter), the additional
detection rate with the Third Eye was 25.0%, and for large adenomas (at
least 10 mm), they found 33.3% more with the Third Eye. Thus, the Third
Eye not only allowed for identification of more polyps, but its greatest
yield was in the detection of larger adenomas, which are further along in
the progression to cancer.
"These data have a very real impact on patients, who benefit when the Third
Eye helps us find adenomas and other polyps that otherwise might have been
missed during colonoscopy," said Dr. Waye. "Colorectal cancer is the
second leading cause of cancer deaths in the United States, but it is
preventable through the early detection of pre-cancerous lesions. The data
show that the Third Eye enhances our ability to detect adenomas, and we
believe that will improve long-term patient outcomes."
The second study was led by Dr. Daniel C. DeMarco, Director of Endoscopy at
Baylor University Medical Center, Dallas, TX. Titled "Impact of Experience
with a Retrograde-Viewing Device on Adenoma Detection Rates and Withdrawal
Times during Colonoscopy: the Third Eye Retroscope Study Group," the study
involved 298 patients at 9 U.S. sites, and was conducted by 17
investigators who had not previously used the device.(2)
Overall, beginning with the very first time they used the device, the Third
Eye allowed the investigators to find 16.0% more adenomas in addition to
those they were able to find with the colonoscope alone. However, after
each investigator had gained some experience with the device by performing
15 procedures, their average additional adenoma detection rate with the
Third Eye compared to the colonoscope alone was 25.0%. Again considering
their overall results from start to finish, the endoscopists found a higher
proportion of larger pre-cancerous adenomas that were hidden from the
colonoscope by folds, including 24.3% more adenomas at least 6 mm in
diameter and 19.0% more adenomas at least 10 mm.
"Previous studies have shown that 22 to 24% of adenomas of all sizes and
12% of adenomas over 10 mm in diameter are missed with the standard
colonoscope," said Dr. DeMarco, the Principal Investigator. "This study
showed that after completing only 15 procedures with the new device, the
investigators achieved a 25% mean additional adenoma detection rate, which
resembles the well-documented miss rate for the colonoscope alone. This is
exciting because cancer is prevented when we find and remove adenomas
before they have a chance to progress to cancer."
"We are very pleased with the results of these two studies," said Dr. Jack
Higgins, Chief Medical Officer of Avantis Medical Systems. "Collectively,
the Waye study and DeMarco study included results from 547 patients. Both
of these studies demonstrated that adenoma detection rates can be
significantly improved through use of the Third Eye, especially for the
larger adenomas that are most clinically significant. It makes sense that
lesions that are hidden behind folds where they can be found only with the
Third Eye were likely missed during previous exams, so they've had time to
grow larger and potentially more dangerous."
The Third Eye was shown to be extremely safe, and there were no adverse
events resulting from use of the device in either of the studies.
About the Studies
The objective of the 249-patient, 8-center study led by Dr. Waye was to
evaluate the added benefit for polyp detection during colonoscopy using a
retrograde-viewing device. The study results included:
-- 257 polyps (including 136 adenomas) were identified with the
colonoscope alone. The Third Eye allowed detection of 34 additional
polyps -- including 15 additional pre-cancerous adenomas that were
hidden from the view of the colonoscope because they were located
behind folds.
-- For lesions 6 mm or larger, the mean additional detection rates with
the Third Eye Retroscope were 18.2% for all polyps and 25.0% for
adenomas.
-- For lesions 10 mm or larger, the additional detection rates with the
Third Eye were 30.8% for all polyps and 33.3% for adenomas.
-- In 28 individuals (11.2%), at least 1 additional polyp was found with
the Third Eye.
The objective of the 298-patient, 9-center study led by Dr. DeMarco was to
evaluate whether experience with the Third Eye Retroscope affects polyp
detection rates and procedure times in physicians who were experienced
colonoscopists but who had not previously used the Third Eye except during
training with a plastic model of the colon. The study findings included:
-- Overall, 182 polyps were seen with the colonoscope and 27 additional
polyps were detected with the Third Eye Retroscope, a 14.8% increase.
-- Overall, 100 adenomas were detected with the colonoscope and 16 more
with the Third Eye Retroscope, a 16.0% increase.
-- For procedures performed after each physician had completed 15
procedures, the mean additional detection rates with the TER were 17.0%
for all polyps and 25.0% for adenomas.
-- For lesions 6 mm or larger, the overall additional detection rates with
the Third Eye Retroscope were 23.2% for all polyps and 24.3% for
adenomas.
-- For lesions 10 mm or larger, the overall additional detection rates
with the Third Eye were 22.6% for all polyps and 19.0% for adenomas.
-- In 27 patients (9.1%), at least 1 additional polyp was found with the
Third Eye.
About Gastrointestinal Endoscopy
Gastrointestinal Endoscopy is the official journal of the American Society
for Gastrointestinal Endoscopy. Gastrointestinal Endoscopy publishes
original, peer-reviewed articles on endoscopic procedures used in the
study, diagnosis and treatment of digestive diseases. Articles report on
outcomes research, prospective studies and controlled trials of new
endoscopic instruments and treatment methods. Gastrointestinal Endoscopy
has become the international forum for the newest developments in the
specialty, bringing readers challenging reports from leading authorities
throughout the world.
About the Third Eye Retroscope and Avantis Medical Systems, Inc.
Avantis Medical Systems, Inc. markets the Third Eye Retroscope, an
FDA-cleared, disposable, catheter-based camera indicated for use with a
standard colonoscope to provide an additional view of the colon for
diagnostic purposes. Deployed through the instrument channel of a standard
colonoscope, the Third Eye provides the physician with a backward view to
complement the colonoscope's forward view of the lining of the colon. The
device is commercially available to physicians who perform colonoscopies.
The Third Eye is the only technology cleared by the FDA that enhances polyp
detection when used in conjunction with a colonoscope. Although
colonoscopy is the gold standard for preventing colon cancer by finding and
removing polyps and other lesions, clinical literature documents that up to
22-24% of adenomas of all sizes(3,4) and 12% of adenomas over 10 mm in
size(5) can be missed. The Third Eye has been shown in clinical studies to
help physicians find up to 25% more adenomas than a standard colonoscope
alone.
Avantis Medical is focused on delivering cost-effective solutions for
improved detection and prevention of cancers of the gastrointestinal tract.
The company has an extensive portfolio of patents covering innovative
devices based on the convergent technologies of micro-chips, enhanced video
processing and catheter-based delivery systems. For more information,
visit
www.AvantisMedical.com or
www.ThirdEyeRetroscope.com.
(1) Waye JD, Heigh RI, Rex DK, et al. A Retrograde-Viewing Device Improves
Detection of Adenomas in the Colon: A Prospective Efficacy Evaluation.
Gastrointest Endosc 2010;71:551-6.
(2) DeMarco DC, Odstrcil E, Lara LF, et al. Impact of Experience with a
Retrograde-Viewing Device on Adenoma Detection Rates and Withdrawal Times
during Colonoscopy: the Third Eye Retroscope Study Group. Gastrointest
Endosc 2010;71:542-50.
(3) Rex DK, Cutler CS, Mark DG, et al. Colonoscopic miss rates of adenomas
determined by back-to-back colonoscopies. Gastroenterology 1997;112:24-8.
(4) Van Rijn JC, Reitsma JB, Dekker E, et al. Polyp Miss Rate Determined by
Tandem Colonoscopy: A Systemic Review.
Am J Gastroenterol 2006;101:343-50.
(5) Pickhardt PJ, Nugent PA, Schindler WR, et al. Location of adenomas
missed by optical colonoscopy.
Ann Intern Med 2004;141:352-9.
Contact Information: Avantis Medical Systems
Doug Gielow
(408) 636-7263