Given Imaging Announces New Studies That Affirm PillCam SB as the Gold Standard for Detecting and Diagnosing Small Bowel Diseases

Given Imaging Ltd, (Nasdaq:GIVN), a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced results from four studies confirming PillCam SB as the gold standard for detecting diseases of the small bowel. The studies were presented at United European Gastroenterology Week (UEG Week) taking place October 12-16, 2013 in Berlin, Germany where Given Imaging will be exhibiting throughout the conference at Booth #7, located in Hall 15.1.

Key findings from PillCam SB studies presented at UEG Week included:

 --  PillCam SB led to a new diagnosis in over 40% of IBD cases

 --  PillCam SB provides relevant findings in over 50% of patients who underwent capsule endoscopy for unexplained Iron Deficiency Anemia after negative upper and lower GI endoscopy

 --  Emergency use of PillCam SB in patients with signs of acute upper/mid gastrointestinal bleeding whose gastroscopy exams were negative detected the bleeding source and helped guide further therapy

 --  PillCam SB is a useful and safe diagnostic modality in children with suspected small-bowel diseases in the largest cohort of pediatric patients

"In the area of small bowel evaluation, PillCam SB is widely used by the GI community and is considered a highly accurate diagnostic modality," said  Fevronia Kiparissi M.D., Department of Gastroenterology, Great Ormond Street Hospital NHS Foundation Trust, London, United Kingdom. "The studies being presented at UEG Week demonstrate PillCam's potential to improve diagnostic yield and change the course of treatment in cases where other modalities failed to identify conditions of the small bowel leading to better outcomes for patients suffering from inflammatory bowel disease, gastrointestinal bleeding, or iron deficiency anemia. This is especially valuable for pediatric patients which we have been following-up for many years."

"The Diagnostic Value in Pediatric Small Bowel Assessment by Wireless Capsule Endoscopy: A Tertiary Center Experience," poster P1333: presented by Efstratios Saliakellis M.D., and colleagues, Great Ormond Street Hospital, NHS Foundation Trust, London, United Kingdom, assessed the diagnostic value, tolerance and safety of PillCam in pediatric patients. The retrospective review of PillCam capsule endoscopy (CE) in 291 children showed over 60% had positive findings and 34% were diagnostic in terms of establishing a diagnosis or altering the therapeutic approach in the patient. The results, which represent the largest cohort of pediatric patients and include the youngest child ever to undergo capsule endoscopy, demonstrated that with careful selection, CE is a useful and safe diagnostic modality in children with suspected small bowel diseases.

"Why Should We Still Use Capsule Endoscopy in Inflammatory Bowel Disease," oral presentation OP430: presented by Lucia Marquez M.D., and
colleagues, Hospital del Mar, Digestive Diseases, Barcelona, Spain, analyzed the impact of PillCam capsule endoscopy (CE) on the diagnosis and management of suspected or established Inflammatory Bowel Disease (IBD). Results confirmed that CE findings led to a new diagnosis in over 40% of cases and that CE is a useful tool for diagnosis of new IBD as well as for guiding treatment.

"Findings and Long Term Outcomes for Patients Following Video Capsule Endoscopy to Investigate Iron Deficiency Anemia," poster P1336: presented by Janisha Patel M.D., and colleagues, Kings College Hospital, Dept. of Hepatology, London, United Kingdom, observed long term outcomes in patients who have undergone capsule endoscopy to investigate iron deficiency anemia (IDA). The results of this retrospective study analyzing long term outcomes of 115 patients who had a negative upper and lower GI endoscopy, showed capsule endoscopy (CE) presented relevant findings in over 50% of patients who underwent CE to investigate unexplained IDA and a significant number of these patients were then actively treated.

"Emergency Video Capsule Endoscopy in Patients with Acute Gastrointestinal Bleeding, poster," poster P1332:presented by Christoph Schlag M.D., and colleagues, Technical University Munich, Munich, Germany, analyzed the use of PillCam capsule endoscopy (CE) for acute gastrointestinal bleeding in the emergency setting. Of the patients who failed to have their source of bleeding identified with gastroscopy, 93% showed complete examination using emergency CE and 73% had the bleeding source identified with CE. Results confirm that for patients with signs of acute upper/mid gastrointestinal bleeding who have had a negative gastroscopy, emergency CE can be used to immediately detect the bleeding source and to guide therapy.