Given Product Ok'd for Further Use

Given Imaging ( GIVN ) , a producer of gastrointestinal products and a developer of capsule endoscopy, recently announced that the Food and Drug Administration (“FDA”) provided updated clearance for its PillCam SB video capsule, including a clearance to encourage its usage for checking lesions that may indicate Crohn’s disease.

The PillCam SB capsule has been marketed since 2001 for visualization of the small bowel mucosa. It can be employed as a tool for detecting abnormalities in the small bowel of adults and children above 2 years of age. The latest labeling is an outcome of the sizeable body of clinical information backing the use of PillCam capsule endoscopy for visualization of lesions arising from a number of indications, including Iron Deficiency Anemia, Crohn’s disease and obscure gastrointestinal bleeding.

Crohn’s disease, which is a chronic condition, leads to inflammation of the lining of the wall of the small intestine. It is accompanied by symptoms such as stomach ache, diarrhea, loss of weight and bleeding of the rectum. Approximately one-half of the cases of Crohn’s disease are detected in the final portion of the small intestine. It is estimated that the condition afflicts half a million Americans.

There is no cure for the disease whose cause is largely unknown; but according to a popular theory, the immune system reacts to a bacterium or virus that causes the inflammation.

Iron Deficiency Anemia is a frequently occurring form of anemia where the victim is short of sufficient healthy red blood cells. The body’s capability to carry oxygen is impacted by the shortage of iron in the blood thereby causing weakness, tiredness, lightheadedness and irritability. Occult gastrointestinal bleeding is marked by bleeding from the digestive tract. The source of bleeding is often unknown and there are many potential causes.

The PillCam capsules are small video cameras that are ingested by patients. The PillCam SB video capsule, which is frequently used for small bowel evaluation, weighs under 4 grams. The second generation PillCam SB 2 includes an imaging device and source of light. It is capable of transmitting two images every second to generate over 50,000 images during a procedure.

Given Imaging promotes gastrointestinal visualization by manufacturing patient-friendly tools based on its PillCam Platform. The PillCam Colon, which is an investigational device, is intended to visualize the colon. Other capsule products from the company include Agile patency capsule, to establish intestinal patency, and Bravo, which is the only commercially available, catheter-free, wireless, 48-hour pH test, for pH testing to measure gastroesophageal reflux disease.

Given Imaging took over Sierra Scientific Instruments in April 2010. The company is headquartered in Yoqneam, Israel with operations in different regions of the globe. Given Imaging faces competition from other existing know how for detecting gastrointestinal disorders. Its main competitors include General Electric Healthcare Systems, a unit of General Electric Co. ( GE - Analyst Report ) , Siemens Medical Solutions, a division of Siemens AG ( SI - Analyst Report ) , and Philips Medical Systems Ltd, a unit of Philips ( PHG - Analyst Report ) .