Given Imaging to highlight Capsule Endoscopy's growing clinical utility at Digestive Disease Week

Yoqneam 12 May 2003Given Imaging has announced that data from 85 oral and poster presentations at Digestive Disease Week 2003 (DDW), taking place in Orlando, Florida, from May 17th - 22nd at the Orange County Convention Center, demonstrate the increasing clinical utility of capsule endoscopy (CE) over conventional diagnostic methods in diagnosing diseases of the small bowel, including Crohn's disease, cancer and obscure bleeding.

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Digestive Disease Week is the largest international gathering of physicians, researchers and academics in the fields of gastro-enterology, haepatology, endoscopy and gastro-intestinal surgery. The event is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastro-enterological Association (AGA), the American Society for Gastro-intestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT). The meeting showcases approximately 5000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

A large number of presentations is focusing on the way in which CE changes the patient outcomes and provides diagnosis for chronic complaints such as consistent abdominal pain and recurring diarrhea. For the first time, clinicians are presenting data on CE's role in diagnosing children with obscure bleeding disorders and as a means for helping to manage patient outcomes in chronic disorders such as Crohn's and celiac disease.

"In the two years since its clearance by the Food and Drug Administration (FDA), capsule endoscopy has changed the practice of gastro-enterology by allowing us to diagnose disorders of the small bowel faster and with greater efficacy", stated Christopher J. Gostout, MD, Division of Gastro-enterology and Haepatology, Mayo Clinic, Rochester, Minnesota, and President-Elect of the American Society of Gastro-intestinal Endoscopy (ASGE). "We look forward to the discussions at DDW about future applications of capsule endoscopy."

"The data presented at DDW 2003 underscores the vital role that capsule endoscopy is playing in the effective management of patients suffering from a growing range of small bowel disorders", stated Gavriel D. Meron, CEO and President of Given Imaging Ltd. "We have seen that as the scientific body of knowledge about CE's diagnostic and clinical value grows, it drives expanded reimbursement coverage, both for more payers as well as for additional indications which leads to broader adoption of capsule endoscopy and increased utilisation."

Highlights of DDW 2003 related to capsule endoscopy include:

  • A clinical symposium sponsored by the American Society of Gastro-intestinal Endoscopy (ASGE), "Capsule Endoscopy: Beyond Bleeding"
  • Six presentations on the use of CE for the detection and ongoing management of Crohn's disease compared to conventional diagnostic tools:
    1. "Videocapsule Endoscopy: A Blinded Comparison to Small Bowel Contrast Study in the Diagnosis of Crohn's Disease"
    2. "Does the Small Intestinal Mucosa Heal in Patients with Crohn's Disease? A Prospective Comparison of Wireless Capsule Endoscopy with Standard Endoscopy, CT Enteroclysis and Ultrasonography."
    3. "Wireless Capsule Endoscopy (CE) is More Informative than Ileoscopy and SBFT for the Evaluation of the Small Intestine (SI) in Patients with Known or Suspected Crohn's Disease."
    4. "Wireless Capsule Endoscopy (WCE) is Useful for Diagnosis and Monitoring of Small Bowel Crohn's Disease."
    5. "Utility of Wireless Capsule Enteroscopy (WCE) versus Serology in the Evaluation of Small Bowel Crohn's Disease."
    6. "Diagnosing Small Bowel (SB) Crohn's Disease (CD): Video Capsule Endoscopy (VCE) and CT Enterography (CTE) Lead the Way; Small Bowel Follow Through (SBFT) Less Helpful."
  • Four presentations discussing the role of CE on patient outcomes management including:
    1. "Wireless Capsule Endoscopy of the Small Intestine: Does It Really Impact the Management Strategy?"
    2. "Does Capsule Endoscopy Change the Management of Patients?"
    3. "Surgical Experience Following Capsule Endoscopy."
    4. "Role of Capsule Endoscopy in the Management of Obscure GI Bleeding."
  • Several abstracts evaluating use of Capsule Endoscopy in children, including:
    • "Wireless Capsule Endoscopy for Obscure Small Bowel Disorders: Final Results of the First Paediatric Trial."
    • "Assisted Wireless Capsule Endoscopy in Six Year-old with Abdominal Pain and Obscure GI Bleeding."
    • "Wireless Capsule Endoscopy in Children: A Study to Assess the Diagnostic Yield in Small Bowel Disease in Paediatric Patients."

More than 100 million people individuals worldwide are now covered by formal policies that enable reimbursement for capsule endoscopy procedures. In the United States, there are approximately 86 million individuals with reimbursable access to capsule endoscopy procedures, representing 35% of the total insured U.S. population. Outside of the United States, the health ministries of Austria and Portugal approved reimbursement coverage of capsule endoscopy in their public hospitals which means that 18 million Europeans now have access to capsule endoscopy.

Given Imaging develops, produces and markets the Given Diagnostic System featuring the M2A Capsule Endoscope, the only non-invasive method for direct visualisation of the entire small intestine. The system uses a disposable miniature video camera contained in a capsule which is ingested by the patient. The M2A capsule passes naturally through the digestive tract, transmitting high quality colour images, without interfering with the patient's normal activities.

The system received clearance from the FDA in August 2001 and received permission to affix the CE mark in May 2001. Distribution channels for the system have been established in more than 50 countries worldwide. The M2A has been utilised to diagnose a range of diseases of the small intestine including Crohn's Disease, Celiac disease and other malabsorption disorders, benign and malignant tumours of the small intestine, vascular disorders, medication related small bowel injury, as well as a range of paediatric small bowel disorders. More news on the M2A capsule is available in the VMW March 2003 article Capsule endoscopy is a superior tool for diagnosing chronic inflammation in small intestine.


Leslie Versweyveld

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