MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Avantis keeps ‘3rd eye’ open
for detecting colon cancer
By OMAR FORD
Medical Device Daily Staff Writer
Avantis Medical Systems (Sunnyvale, California) is
getting a better view when it comes down to properly finding
tumors during colonoscopies. And the company literally
means that.
The company reported this week that it has received
510(k) clearance from the FDA for its Third Eye Restroscope,
a chip-on catheter device. Avantis said it is in a limited market
release of the device.
The device literally is the “third eye” when it comes to
performing colonoscopies, said Scott Dodson, CEO of
Avantis.
“One eye is the physician’s eye, another is the colonscope’s
eye and the third and final eye is the third eye,” he
told Medical Device Daily.
The Third Eye Retroscope is indicated for use with
colonoscopy to provide the physician with an additional
view of the colon for diagnostic and detection purposes.
Shaped like a J, the device is passed through the instrument
channel of a standard colonoscope until it extends
beyond its tip. As it emerges, the device automatically turns
180 degrees to aim “backward” toward the tip of the colonoscope.
Then, as the colonoscope is withdrawn from the
colon, the device provides a continuous retrograde view to
reveal polyps, cancers and other lesions that might be hidden
from the view of a standard colonoscope.
“It operates as a rear-view mirror for the physician,”
Dodson told MDD.
The device includes:
• An integrated light source on the catheter provides
illumination without the need for a costly additional external
light source.
• Retrograde view that reveals areas behind folds in
the colon wall.
• A foot pedal that captures still images from both the
forward and retrograde views simultaneously.
• A video processor and monitor integrate with standard
colonoscopy systems and display both forward and
retrograde views on the same monitor.
To date the device has been used in clinical trial settings
and is being prepped to hit the market.
“Our national study indicated that the Third Eye
Retroscope, when used in combination with a standard forward-viewing
colonoscope, revealed areas that are often
hidden from the standard colonoscope,” said Douglas Rex,
MD, Third Eye investigator, at Indiana University School of
Medicine and director of endoscopy at Indiana University
Hospital (both Indianapolis). “The device also enabled
detection of 13% more polyps and 10.9%more adenomas
than the colonoscope alone. These results are important to
19
doctors and patients because most cases of colon cancer
arise from adenomas.”
Colorectal cancer is the second-leading cause of cancer
death in the U.S. and Europe. Most of these cancers can be
treated if hif they are detected early and even more cases
can be prevented if pre-cancerous polyps are removed
before they become malignant. However research has
shown that 12% to 24% of polyps and a significant number
of cancers can be missed during colonscopies.
Even more revealing is a recent large study analysis
involving more than 10,000 cancer patients who died of colorectal
cancer that indicated that colonoscopy missed
about one-third of colorectal cancers on the left side of the
colon and 40% to 67% of the colorectal cancers on the right
side of the colon. The company said that the study showed
that twice the number of patients had polyps on the rightside
of the colon vs. the left side.
“Unlike most market development technologies, there
isn’t a need to prove the need for the device, there is welldocumented
evidence that shows us there is a clear need
for the device,” Rex said. “The miss rates for a colonoscopy
is incredible. This remains one of the most hotly contested
topics for gastrointestinal specialists (GI).”
One could argue the point that this was not only a serious
matter for GIs but also for venture capitalists and
financers. Even in a tough economy, financiers continued to
support Avantis and its vision and the company was able to
close on $10 million in Series C founding to facilitate the
launch of the Third Eye (Medical Device Daily, Jan. 21, 2009).
The company raised $12 million in its Series B round of
financing in October 2006.
(This story originally appeared in the Feb. 19, 2009, edition
of Medical Device Daily)
To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547.
Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.