http://www.givenimaging.com/Cultures/en-US/Given/english/About/NewsAndEvents/PressReleases/PR20031110_BCBSA.htm Given Imaging Announces Blue Cross and Blue Shield's Technology Evaluation Center Clears Capsule Endoscopy for Initial Diagnosis in Patients With Suspected Crohn's Disease
YOQNEAM, Israel, Nov. 10 /PRNewswire-FirstCall/ -- Given Imaging (Nasdaq: GIVN - News) announced today that the Blue Cross and Blue Shield Association's Medical Advisory Panel has determined that 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.
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 specialties. The Panel includes appointees from the American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics, 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," said 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 Blue Shield's long track record of leadership in making effective technologies and therapies available to its members."
About Given Imaging
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 color 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 tumors of the small intestine, vascular disorders, medication related small bowel injury, as well as a range of pediatric small bowel disorders. For more information, visit http://www.givenimaging.com.
This press release contains forward-looking statements about Given Imaging, including projections about our business, our future revenues, and our future 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 possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission.
Source: Given Imaging