Healthcare Industry News:  Given Imaging 

Devices Gastroenterology

 News Release - June 12, 2006

Updated Consensus Guidelines for Capsule Endoscopy Established at International Conference in Paris

New Research Presented on PillCam Technology for Various Gastroenterology Indications Including Small Bowel Tumors and Crohn's Disease

YOQNEAM, Israel, June 12 (HSMN NewsFeed) -- Given Imaging (Nasdaq: GIVN ) announced today that physicians at the International Conference on Capsule Endoscopy(TM) (ICCE(TM)) revised consensus guidelines for PillCam(TM) capsule endoscopy use based on the growing body of data presented at the conference, which took place June 9 and 10 in Paris, France. This year's conference highlighted more than 82 abstracts of which 19 were accepted for oral presentation. More than 300 physicians participated in the meeting, which was co-chaired by Blair Lewis, M.D., Clinical Professor of Medicine and Gastroenterology at the Mount Sinai School of Medicine in New York, and Roberto De Franchis, M.D., Professor of Medicine at the University of Milan in Italy and Gerard Gay, University Hospital, Nancy, France.

"ICCE Paris is an opportunity for European physicians to share the latest information about new and expanded indications for capsule endoscopy. There were several large studies which validated earlier findings about the impact of capsule endoscopy on clinical outcomes, in identifying small bowel tumors and in definitely detecting Crohn's disease," said Roberto De Franchis, M.D., Professor of Medicine at the University of Milan, Italy.

The final 2006 ICCE consensus document will be published later this year.

Key Data Presented

Three posters were selected by the co-chairmen and presented at the June 10 plenary session. Highlights of the posters include:

-- Researchers at the Georges Pompidou European Hospital in Paris, France, examined the diagnostic yield of capsule endoscopy in detecting lesions outside of the small intestine that are missed by traditional endoscopy. Researchers identified a cause of bleeding outside of the small intestine in 26 patients or 7% of cases. Lesions were found in the stomach, proximal duodenum and cecum. (Abstract 366470)

-- A team of researchers at the Martin-Luther University Hospitals and Clinics, Germany, conducted a 22 patient study comparing the comfort of capsule endoscopy in diagnosing small bowel to MRI and Enteroclysis. Patient comfort was graded in a questionnaire on a scale of 0 for no stress at all to 10 for unbearable stress for each imaging method. The mean stress grade for capsule endoscopy was 1.1, significantly less than stress associated with MRI 4.4 and enteroclysis 5.6. (Abstract 371907)

-- Physicians from Catholic University Digestive Endoscopy Unit in Rome, Italy, evaluated the feasibility and safety of non-assisted capsule endoscopy in eleven patients who previously had undergone stomach surgery. In nine of the eleven patients, the capsule passed into the

small bowel directly as confirmed by fluoroscopy. In two other patients, endoscopy-assisted positioning of the capsule was necessary. Researchers concluded that capsule endoscopy is safe and feasible in patients who have undergone gastro duodenal surgery. (Abstract 366720)

Other notable abstracts presented at the conference included:

Crohn's Disease

-- Researchers at Malmo University Hospital, Lund University, Sweden, conducted a study of 65 patients with suspected or known Crohn's disease comparing the diagnostic value of capsule endoscopy to conventional imaging methods including barium enterography, push enteroscopy and ileo-colonoscopy. One or more of the diagnostic imaging methods identified Crohn's lesions in the small bowel in 38, or 58%, of the patients. All cases of small bowel Crohn's disease detected by conventional imaging methods were detected using capsule endoscopy. Capsule endoscopy alone identified eight additional patients with Crohn's disease and detected more extensive disease in 12 patients. The sensitivity of capsule endoscopy for detecting small bowel Crohn's disease was 0.87, whereas sensitivity of ileoscopy, barium enterography and push enteroscopy was only 0.58, 0.21 and 0.13, respectively. The authors concluded that capsule endoscopy should be the method of choice in patients with suspected non-stricturing Crohn's disease in the small bowel. (Abstract 366760)

PillCam ESO

-- Researchers at the Hopital Edouard Herriot in Lyon, France conducted a 20-patient prospective study comparing esophageal capsule endoscopy to esophago-gastro-duodenoscopy (EGD) in evaluating portal hypertension in cirrhotic patients. The study concluded that PillCam ESO is feasible, safe, accurate and preferred by cirrhotic patients undergoing screening of portal hypertension. (Abstract 314834)

Tumors

-- A team of researchers at the Centre Hospitalier Universitaire de Nancy, Toulouse, France, conducted a 389-patient study aimed at describing the clinical course and outcome of patients with tumors diagnosed by capsule endoscopy. In the study, capsule endoscopy found tumors in 11.7% of the patients who presented with obscure GI bleeding. The 38 of the 48 patients diagnosed with tumors underwent surgery, and 87% of the surgical patients were alive after one year. This study concluded that the prevalence of intestinal tumors is higher than previously reported in patients with obscure GI bleeding and that surgical or endoscopic removal of the tumor improves patient outcome. (Abstract 367091)

-- Researchers at the Malmo University Hospital, Lund University, Sweden, conducted a 667-patient study to determine the value of capsule endoscopy in diagnosing small bowel tumors. The study found that capsule endoscopy identified tumors in 7.7% of patients with obscure GI bleeding. Overall, the tumor incidence rate was 2.7%. This study concluded that the tumor incidence rate in the small bowel is higher than previously thought. The study also suggests the importance of including capsule endoscopy in the work-up of patients with obscure GI bleeding. (Abstract 366764)

Bleeding

-- Members of the Italian Capsule Endoscopy Club conducted a 274 patient retrospective study evaluating the cost-effectiveness of capsule endoscopy in patients with mid-GI bleeding (MGIB). The study found that 58.4% of patients had positive findings with capsule endoscopy compared to 30.4% with other imaging procedures. The study found the mean cost of a positive diagnosis with capsule endoscopy was euro 2, 090 while that with other procedures was euro 3,828, implying a mean cost savings of euro 1,738. (Abstract 364658)

-- Final results of a randomized, controlled trial evaluating the efficiency of capsule endoscopy compared to push enteroscopy as a first line tool in the detection of obscure gastrointestinal bleeding were presented by researchers from Georges Pompidou European Hospital and France and Lariboisiere Hospital, both located in Paris. Authors concluded that capsule endoscopy as a first line exploration for obscure gastrointestinal bleeding is the most efficient strategy in terms of diagnosis, accurately detecting the lack of disease and number of added examinations performed, provided that the negative predictive value of capsule endoscopy for small bowel lesions is taken into account and any source of bleeding is accurately detected by conventional endoscopy. (Abstract 366477)

About ICCE

Started in 2002, the International Conference on Capsule Endoscopy is the main forum for leading gastroenterologists and key opinion leaders to exchange scientific, clinical and practical information about capsule endoscopy. For more information visit http://www.2006ICCE.com.

About Given Imaging

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the GivenŽ Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam SB capsule is a naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 340,000 patients worldwide. The PillCam ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing, and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain, and Australia. For more information, visit http://www.givenimaging.com.

This press release contains forward-looking statements about Given Imaging, including projections about our business and our future revenues, expenses and profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the impact of the newly adopted SFAS 123R for expensing option-based payments, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities and Exchange Commission.


Source: Given Imaging

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