NutritionOver Half Of Eligible OGIB Patients May Benefit From Small Bowel Capsule Endoscopy
Given Imaging Ltd.
(NASDAQ: GIVN) announced a new study that shows over half of
the eligible patients with occult or obscure gastrointestinal
bleeding (OGIB) may benefit from the additional diagnostic
information provided by small bowel capsule endoscopy in accordance
with existing gastrointestinal (GI) society guidelines, which call
for the patient-friendly, non-invasive procedure following a negative
upper endoscopy and colonoscopy. Additional studies advocate broader
utility of capsule endoscopy in iron deficiency anemia (IDA) and
suspected small bowel Crohn"s disease. The studies were presented at
the Digestive Disease Week(R) (DDW) 2009 conference taking place in
Chicago from May 30 - June 4, where Given Imaging also demonstrated a
new, simplified procedure for performing PillCam(R) capsule endoscopy
of the small bowel and the latest version of its RAPID(R) Software
Suite at booth #2235 at the conference.
In presentation #299, Professor Ian M. Gralnek, of the
Technion-Israel Institute of Technology and Rambam Medical Center,
Haifa, Israel, concluded that based on an analysis of a US-based,
multi-payer medical claims database that analyzed the records of 2.7
million adults suspected of GI bleeding, less than half of patients
with OGIB and a negative endoscopic workup had received a diagnostic
capsule endoscopy procedure in accordance with guidelines set by GI
societies, including the American Society for Gastrointestinal
Endoscopy and the American Gastroenterological Association, and the
British Society of Gastroenterology. This study also found extensive
use of contrast radiography, an x-ray or gamma-ray based test.
"Capsule endoscopy is recognized as the diagnostic standard of care
for OGIB, but many patients are undergoing multiple tests, such as
contrast radiography, that are less conclusive and expose them to
additional radiation," said Professor Gralnek. "Several studies also
show that PillCam SB is a clinically and economically effective tool
among patients with IDA and those with suspected small bowel Crohn"s
disease."
Additional studies presented at DDW provide evidence for broader use
of PillCam SB in IDA and suspected small bowel Crohn"s disease:
-- A poster presentation (#W1082) led by Professor Gralnek that analyzed
a US-based, multi-payer medical claims database and found a high use of
contrast radiography studies in the evaluation of patients with unexplained
iron deficiency anemia (IDA) despite current published data demonstrating
the diagnostic value of capsule endoscopy. Of 37,338 patients with a
potential need for small bowel capsule endoscopy, only 7,894 capsule
endoscopy studies were performed (21 percent of expected) while 30,088
received contrast radiography. Small bowel capsule endoscopy is recommended
in males and selected females with IDA and negative upper endoscopy and
colonoscopy.
-- A poster presentation (#W1084) led by Jonathan A. Leighton, of the
Mayo College of Medicine in Scottsdale, Arizona concluded that capsule
endoscopy is less costly than small bowel follow through (SBFT) for
evaluating patients with suspected small bowel Crohn"s disease. Using a
decision analytic model, researchers compared estimated total costs for
diagnosis and disease management for one year.
-- A poster presentation (#T1515) led by Professor Gralnek reports an
extensive literature review utilizing the six most accepted evidence
grading systems(1) and concluded that clinicians and policymakers have
evidence to use capsule endoscopy for patients with suspected Crohn"s
disease. The grading systems used in the study were developed to assist
clinicians and policymakers in determining when sufficient evidence has
accumulated to incorporate new technologies into clinical practice.
New, Simplified Procedure for PillCam(R) of the Small Bowel
In separate news, the company also demonstrated a simplified
procedure for performing PillCam capsule endoscopy of the small
bowel. First unveiled to nurses at the Society of Gastroenterology
Nurses and Associates (SGNA) meeting which took place in St. Louis,
from May 15 - 20, the simplified procedure that uses the new
SensorBelt with the RecorderPouch and obviates the need to use the
sensor array and recorder belt previously required.
The new procedure has been very well received, with nurses surveyed
indicating that this new procedure would save them time and be
welcomed by their patients. Specifically, the nurses also indicated
that, on average, they would save 15 to 30 minutes of preparation and
maintenance time per procedure. Both products can be washed or
disinfected using common liquid disinfectants and are priced to
enable cost-effective reorder. The RecorderPouch is available now
while the SensorBelt is pending 510(k) clearance.
"This new procedure makes a patient-friendly diagnostic test even
easier while improving workflow productivity at the same time," said
Pat Moushey, RN, CGRN, St. Luke"s Hospital, St. Louis. "The
SensorBelt reduces the time required to prepare the patient for a
capsule endoscopy and time spent on equipment preparation and
maintenance. The RecorderPouch is less visible and allows greater
freedom of movement for patients."
Next-Generation Software
The latest version of RAPID(R) Software Suite, which includes RAPID
6, RAPID(R) 6 Access and RAPID(R) 6 Reader, incorporates the following
new
features:
-- Image Adjustment with FICE (Flexible spectral Imaging Color
Enhancement), developed by FUJIFILM, a partner of Given Imaging. FICE is an
image-enhancing technology that aids the physician in viewing surface
tissue characteristics and blood vessels by visually enhancing potential
areas of disease;
-- PillCam Progress Indicator, which may aid in planning therapeutic
intervention by providing an estimation of linear distance within the small
bowel along with information concerning rate of capsule progress through
the small bowel;
-- Mosaic View, which allows the reader to view an array of consecutive
images showing how the tissue changes as the PillCam video capsule
progressed;
-- An updated Study Manager and patient management screens including user-
customizable fields, pull-down menus for easy, error-free data entry and an
exportable database.
About Occult GI Bleeding
Occult gastrointestinal bleeding (OGIB) occurs when blood is lost
from the digestive tract without visible, or overt, signs of
bleeding.(2) The condition is usually discovered only with positive
results for a fecal occult blood test or through detection of iron
deficiency anemia, and there are many potential causes. In
approximately half of patients with OGIB, the of bleeding is
unexplained.(3)
About IDA
Iron deficiency anemia (IDA) is a common type of anemia in which the
patient lacks adequate healthy red blood cells.(4) Lack of iron in
the blood affects the body"s ability to carry oxygen and results in
patients feeling tired, weak, irritable and lightheaded. The causes
of IDA vary but can include loss of blood, pregnancy, inadequate
diet, the inability to absorb iron from food and internal bleeding
due to a bleeding ulcer, a colon polyp or colon cancer.(5)
About Crohn"s Disease
Crohn"s disease is a chronic condition that causes inflammation in
the lining of the small intestine wall. It usually occurs in the lower
part of the small intestine called the ileum, but can affect any part
of the digestive tract. Symptoms can include diarrhea, abdominal
pain, weight loss and rectal bleeding. Roughly 50 percent of all
cases of Crohn"s disease are diagnosed in the last part of the small
intestine (the terminal ileum) and cecum. This area is also known as
the ileocecal region. Other cases of Crohn"s may affect one or more
of the following: the colon only, the small bowel only (duodenum,
jejunum and/or ileum), the stomach or esophagus.(6) Roughly 500,000
Americans suffer from Crohn"s disease, and about 20 percent have a
direct relative with some form of inflammatory bowel disease
(IBD).(7) It affects men and women equally. The cause is unknown,
but the most popular theory is that the immune system is reacting to
a virus or bacterium that causes inflammation.(8) An upper GI
endoscopy, upper GI radiography series and colonoscopy are often used
to test for inflammation and intestinal abnormalities. Depending on
the severity, treatment options include nutritional supplements,
drugs and surgery. There is currently no cure for the disease.
About PillCam SB
The PillCam SB video capsule measures 11 mm x 26 mm and weighs less
than four grams. Now in its second generation, PillCam SB 2 contains
an imaging device and light and transmits images at a rate of
two images per second generating more than 50,000 pictures during the
course of the procedure. Initially cleared by the U.S. Food and Drug
Administration in 2001, PillCam SB is clinically validated by close
to 1,000 peer-reviewed studies. It is the most accurate,
patient-friendly diagnostic and monitoring tool for visualization of
the small bowel and is used by physicians to evaluate patients with
obscure GI bleeding, including iron deficiency anemia, suspected
Crohn"s disease, suspected small intestinal tumors and monitoring
patients with polyposis syndromes and in suspected or refractory
malabsorptive syndromes, such as celiac disease. The PillCam(R)
family of products are the gold standard in capsule endoscopy.
Research for studies #299 and W1082 were assisted by Given Imaging.
Professor Ian Gralnek and Jonathan Leighton, M.D., are consultants to
Given Imaging. Denise Malvehy is an employee of Given Imaging.
Digestive Disease Week
Given Imaging Ltd.