Blue Cross and Blue Shield clears Capsule Endoscopy for diagnosis of Crohn's disease

Yoqneam 10 November 2003The Blue Cross and Blue Shield Association's Medical Advisory Panel has determined that Given Imaging's Capsule Endoscopy meets the criteria of the association's Technology Evaluation Center (TEC) for initially diagnosing patients with suspected Crohn's disease, following negative conventional diagnostic tests such as barium follow-through and upper and lower endoscopy.

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The assessment was prepared by the Blue Cross and Blue Shield Association's Technology Evaluation Center (TEC) which provides objective information to individuals who deliver and manage medical care. The TEC bases its assessments on clinical and scientific evidence and evaluates whether a technology improves health outcomes such as length of life, quality of life and ability to function.

The 18-member Medical Advisor Panel (MAP) has scientific and clinical authority and accountability for all TEC assessments. It is comprised of independent, nationally recognized experts in technology assessment, clinical research and medical specialities. The Panel includes appointees from the American College of Physicians, the American Academy of Family Physicians, the American Academy of Paediatrics, and the American College of Surgeons.

"We are pleased with the Blue Cross and Blue Shield Advisory Panel's conclusion that Capsule Endoscopy can be used to help those suffering from symptoms indicative of suspected Crohn's disease obtain a definitive diagnosis", stated Gavriel D. Meron, President and CEO of Given Imaging. "Individual Blue Cross and Blue Shield carriers now have a strong basis to issue coverage decisions for the use of Capsule Endoscopy for suspected Crohn's disease. We believe this decision reflects Blue Cross and Blue Shield's long track record of leadership in making effective technologies and therapies available to its members."

Given Imaging develops, produces and markets the Given Diagnostic System featuring the M2A Capsule Endoscope, the only non-invasive method for direct visualization 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. More than 65.000 capsules have been used in clinical practice. Thousands of patients around the world have benefited from the M2A which has been used 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 information about the Capsule Endoscopy technology can be found in the VMW June 2003 article Given Imaging to highlight Capsule Endoscopy's growing clinical utility at Digestive Disease Week.


Leslie Versweyveld

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