November 29, 2004
New PillCam(TM) ESO for The Esophagus Receives FDA Marketing Clearance
CINCINNATI, Nov. 29 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has given marketing clearance to the new PillCam(TM) ESO, a miniature color video camera in a pill that helps doctors diagnose and evaluate diseases of the esophagus such as gastroesophageal reflux disease (GERD), erosive esophagitis and Barrett's esophagus, a pre-cancerous condition, according to InScope, a division of Ethicon Endo-Surgery, Inc., a Johnson & Johnson (JNJ) company.
The PillCam(TM) ESO was developed and is manufactured by Given Imaging and will be marketed by the InScope Division of Ethicon Endo-Surgery.Every year millions of Americans undergo procedures to examine the esophagus. The most common procedure involves advancing a long, flexible tube (endoscope) into the mouth, down through the throat into the esophagus. The procedure, known as traditional endoscopy, requires sedation and hours of recovery.
The PillCam(TM) ESO is the first non-invasive diagnostic alternative to traditional endoscopy that has been shown in clinical trials to have accuracy comparable to traditional endoscopy. However, the 20-minute office procedure requires no sedation and recovery is immediate.
"This is a technology that could revolutionize how esophageal disease is identified and evaluated," said Blair Lewis, MD, a gastroenterologist at the Mount Sinai School of Medicine in New York City. "More patients are willing to swallow a pill than go through a traditional endoscopy."
The PillCam(TM) ESO is a smooth plastic capsule about the size of a large vitamin pill that has tiny video cameras at each end. A patient lies on his or her back and swallows the pill with water. The pill then glides down the esophageal tract taking about 2,600 color pictures (14 per second), which are transmitted to a recording device worn by the patient. After 20 minutes, the doctor has enough video images to make a definitive diagnosis. The disposable capsule is passed naturally, usually within 24 hours.
According to health experts, most of the 19 million GERD sufferers do not monitor their condition despite the fact that 5% to 15% of GERD patients may have Barrett's Esophagus, a condition that increases the risk of developing esophageal cancer, the fastest growing type of cancer in America. About 700,000 people have Barrett's Esophagus.
GERD sufferers are often treated with prescription or over-the-counter antacids. However, treatments that control symptoms do not prevent the progression of disease.
"Millions of people are chronic antacid users and have never been evaluated for esophageal disease," said Brian Fennerty, MD, a gastroenterologist from Oregon Health & Science University in Portland who has used PillCam(TM) ESO on scores of patients during clinical trials. "We think that the PillCam ESO(TM) will make it easier for people at risk to get that evaluation sooner and keep esophageal disease in check."
The American College of Gastroenterology (ACG) recommends that patients with long-standing GERD symptoms, particularly those 50 and older, should have upper endoscopy to detect Barrett's Esophagus.
The PillCam ESO(TM) is not for everyone. People with dysphagia or other swallowing disorders, pacemakers or with known or suspected gastrointestinal obstruction, strictures or fistulas are not candidates.
For more information on PillCam(TM) ESO, please visit http://www.pillcam.com/, or call toll free 866-InScope.
Another version of the camera pill for the small bowel, PillCam(TM) SB, was cleared by the FDA in 2001 and has been used in more than 150,000 patients. The PillCam(TM) SB video capsule is the only naturally ingested method for direct visualization of the entire small intestine.
About InScope, a Division of Ethicon Endo-Surgery
InScope, a division of Ethicon Endo-Surgery, Inc., is focused on developing and marketing technologies that enable diseases of the gastrointestinal tract to be diagnosed and treated without the need for incisions.
Ethicon Endo-Surgery, Inc. develops and markets a broad portfolio of advanced surgical instruments and medical devices for minimally invasive and traditional surgery. The Company's mission is to help physicians around the world transform patient care through innovation. The Company's focus is on designing innovative, procedure-enabling medical devices for interventional diagnosis and treatment of various diseases and conditions in the areas of general and thoracic surgery, breast disease, gynecology, oncology, and urology. For more information, visit http://www.ethiconendo.com/.
CONTACT: Keith Taylor of InScope, +1-212-527-7537
Web site: http://www.ethiconendo.com/http://www.pillcam.com/