National Government Services Expands Policy To Cover Capsule Endoscopy Of The Esophagus, USA

Main Category: Medical Devices / Diagnostics
Also Included In: GastroIntestinal / Gastroenterology;  Ear, Nose and Throat
Article Date: 11 Oct 2007 - 7:00 PST

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Given Imaging Ltd. (NASDAQ: GIVN), the global leader in capsule endoscopy, today announced that National Government Services (NGS), the Medicare Part B Carrier serving more than 6 million individuals in New York, New Jersey, Kentucky and Indiana, issued a new coverage policy for cirrhotic patients for the evaluation of esophageal varices using capsule endoscopy of the esophagus. The policy becomes effective December 1, 2007. With the addition of the NGS coverage policy to the existing coverage policies, more than 13 million beneficiaries in the United States could have access to PillCam ESO.

Douglas T. Dieterich, M.D., Professor of Medicine, Liver Diseases, Director, Continuing Medical Education, Department of Medicine, Mount Sinai School of Medicine, New York City, said, "Esophageal varices are a major complication of liver cirrhosis and are associated with a rate of mortality of 20%. By allowing Medicare patients access to this less invasive technology, NGS is taking great strides to ensure cirrhotic patients are being evaluated, which will help improve the quality of care for these patients."

Varices are varicose veins that occur in the esophagus as a result of portal hypertension, which is a symptom of cirrhosis. The increased pressure within esophageal varices makes them susceptible to rupture and bleeding. Approximately 360 of every 100,000 Americans have cirrhosis, and gastroesophageal varices are present in 40-60% of these patients.

The company also announced that NGS has added coverage for PillCam SB for the detection of small bowel tumors, evaluation of malabsorption syndrome, and small bowel evaluation prior to a small bowel surgical resection to control loss of blood or protein. Multiple additional ICD-9 codes have also been added.

About PillCam ESO

Cleared by the U.S. Food and Drug Administration in November 2004 to visualize the esophagus in adult patients in a patient-friendly way, physicians can use PillCam ESO to aid in the detection of disorders such as Barrett's esophagus, a potential precursor for esophageal cancer and esophageal varices, which if left untreated, can result in fatal bleeding. PillCam ESO contains imaging devices and light sources at both ends of the capsule that capture up to 14 images per second, a total of 2,600 color images, as it passes down the esophagus in a twenty minute procedure. Exclusive marketing rights for PillCam ESO have been granted to InScope, a division of Ethicon Endo-Surgery, a Johnson & Johnson company.

About Given Imaging Ltd

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are underway in Europe and the U.S. More than 560,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan and Australia. For more information, visit http://www.givenimaging.com.

About Ethicon Endo-Surgery

Ethicon Endo-Surgery, Inc., an operating company of Johnson & Johnson, is a global leader in minimally invasive and traditional surgical devices for bariatric surgery and many other areas of surgery. The company develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, plastic surgery, orthopedics, gynecology and surgical oncology. More information on the company can be found at www.ethiconendo.com.

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