Given Imaging Highlights New Clinical Studies That
Further Validate Efficacy Of The M2A(R) Capsule
Endoscope
German and French Trials Demonstrate Expanded Indications For
Capsule Endoscopy
YOQNEAM, Israel, April 8 /PRNewswire-FirstCall/ -- Given Imaging's (Nasdaq: GIVN -
news) M2A® capsule endoscope detects up to 80 percent of small bowel abnormalities, a
significantly greater percentage than found using traditional methods, according to clinical data
released at two recent international medical conferences. The data also revealed that
physicians are using the capsule to successfully diagnose an expanded list of conditions.
German and French research groups presented results from clinical trials and experience
during the 2002 Congress of the German Society for Endoscopy and Imaging Procedures
(DGE-BV), March 14-16, in Munich and the Journees Francophones de Pathologie, March
23-27, in Nantes, France. The trials studied the effectiveness of the M2A, an ingestible color
video camera that allows, for the first time, visualization of the entire small intestine to diagnose
diseases and disorders of the gastrointestinal tract.
More than 140 patients were involved in the trials. Participating patients were pre-evaluated
using traditional methods such as gastroscopy, colonoscopy, and suffered from a range of
gastrointestinal disorders, e.g., bleeding of the small intestine, iron deficiency anemia, chronic
diarrhea, Crohn's disease, polyps and abdominal pain suspected from the small intestine. In
two independent, controlled trials, led by Professor Gerard Gay, head of gastroenterology, of
the Brabois Hospital, Nancy, France, and Professor Christian Ell, of the HSK Hospital in
Wiesbaden, Germany, respectively, M2A capsule endoscopy demonstrated a statistically
significant increased diagnosis rate compared to push-enteroscopy (an extra-long endoscope,
which is used for examining the small intestine). In another study, Professor Riemann, also
from Germany, demonstrated a detection rate of 76 percent with the M2A, and altered
patient management in 57 percent of his cases after findings from capsule endoscopy.
In another study, M2A capsule endoscopy was conducted on 50 patients suffering from
gastrointestinal bleeding of unknown origin, chronic diarrhea and abdominal pain or had
suspected findings in previous radiological procedures. Lead investigator Professor Friedrich Hagenmuller, of Allgemeines
Krankenhaus Altona, Hamburg, Germany, found that the M2A yielded positive diagnoses in about 80 percent of the cases.
Hagenmuller stated that M2A is a ``quantum leap'' that will introduce a `` new era of research in the small intestine'' and is ``light
years superior to X-ray diagnosis.''
Prof. Horst Neuhaus, of Evangelisches Krankenhaus, Dusseldorf, Germany, presented results from a prospective trial in
Crohn's disease, which compares M2A Capsule Endoscopy with intestinal x-ray. The study focused on patients with known or
suspected Crohn's disease, and preliminary data indicate that the capsule detected more lesions than x-ray, particularly in the
jejunum and the proximal ileum.
According to Neuhaus, the capsule was capable of detecting even discrete inflammatory changes in the small intestine. In
patients where Crohn's disease has already been diagnosed, Prof. Neuhaus recommended performing abdominal ultrasound
before using the M2A capsule to rule out a stenosis or significant obstruction.
In addition, both Profs. Neuhaus and Hagenmuller stated that they expect the M2A to prove beneficial in celiac disease and
sprue in the future. Considering the often frustrating and repetitive examinations required to diagnose patients with small bowel
diseases, both experts expressed the opinion that M2A could present a cost-efficient option.
``Both congresses highlighted that the positive pivotal results for the M2A capsule endoscopy method have been validated in
Europe,'' said Dr. Gavriel Meron, president and CEO of Given Imaging, Ltd. ``As indicated by this data, the method has
superior diagnostic yield when compared with other modalities and is an effective diagnostic tool for a growing range of
indications.''
Results from several other M2A capsule endoscopy trials from physicians around the world will be presented at Digestive
Disease Week (DDW) in San Francisco, May 19 - 22, where more than 30 abstracts on capsule endoscopy have already been
accepted. Capsule endoscopy is also the subject of an American Gastroenterological Association (AGA) Distinguished
Abstract Plenary Session and is one of the American Society for Gastrointestinal Endocopy's (ASGE) ten Topic Fora at DDW.
About Given Imaging
Given Imaging produces and markets the Given Diagnostic System, which features the M2A® Capsule Endoscope, a
fundamentally new approach to examining the gastrointestinal tract. The system uses a disposable miniature video camera
contained in a capsule that is ingested by a patient and delivers high quality color images in a painless and noninvasive manner.
The test can be conducted while a patient continues normal daily activities. The system received clearance from the FDA in
August 2001 and received permission to affix the CE mark in May 2001. It is currently available in the USA, Canada, Europe,
Brazil, Puerto Rico, Venezuela, Mexico, Australia, New Zealand, and Israel. Many thousands of patients suffering from
diseases in the small intestine such as Crohn's, celiac disease, unexplained abdominal pain with diarrhea, polyposis, intestinal
tumors, iron deficiency anemia and obscure bleeding have already benefited from this innovative technology. For more
information, visit www.givenimaging.com .
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SOURCE: Given Imaging |
