After approximately 20 minutes, the PillCam ESO passes naturally through the GI tract. The physician reviews the video at a convenient time and place.One of the most common of all medical problems among adult Americans is gastroesophageal reflux disease (GERD), with approximately 1 in 4 people suffering from this clinical gastrointestinal problem.
According to Dr. M.Brian Fennerty, Professor of Medicine, Oregon Health & Science University, Portland, Oregon, GERD has an enormous impact on healthcare, with costs of drug therapy and surgical intervention of about 6 billion dollars annually. Of those 1 in 4 Americans with GERD, 10% also have Barrett’s esophagus – so about 1 to 2% of the adult population has a pre-malignant condition putting them at risk for adenocarcinoma of the esophagus. Importantly, this cancer has the most rapidly rising incidence of any cancer in the last 30 years.
For those reasons and more, the news that Israeli video capsule pioneers Given Imaging has perfected a miniature video capsule for the esophagus has been met with accolades in the medical community.
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 Given Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCamSB video capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 60 other countries and has benefited more than 122,000 patients worldwide.
Last week, the company raised the bar when it received marketing clearance from the US Food and Drug Administration (FDA) of its new diagnostic system, the PillCam ESO video capsule for imaging the esophagus. Esophageal Capsule Endoscopy enables visualization of the esophagus – assisting in detection of diseases such as suspected Barrett’s Esophagus in patients with GERD.
Given Imaging’s capsule endoscopy procedure was invented by Gavriel Iddan, an electro-optical engineer who previously worked at Israeli military manufacturer Rafael Israel Armament Development Authority, developing guided missile technology. During a sabbatical year in Boston, his neighbor, an Israeli gastroenterologist, challenged him to invent an endoscope that could make its way through the entire gastrointestinal tract. It took about 20 years, but in 1997, Iddan, now the company’s chief technology officer, signed a patent for capsule endoscopy.
The Nasdaq Stock Market-traded company hopes to eventually create imaging solutions for the entire gastrointestinal tract, including the large intestines and colon. With $41 million in sales in 2003, a 40% increase from the previous year, “there are doctors who are ordering capsules every week,” says Sandra Ziv, marketing director at Given.
The new PillCam ESO video capsule is the same size as the company’s small bowel video capsule, PillCam SB, which is 11x26mm. Miniaturization of electronics has enabled the PillCam ESO capsule to include two imaging sensors, one at each end of the capsule. Each imager captures two frames (images) per second, totaling four frames per second.
The present pillcam takes 4 frames per second. Not resting on its laurels, Given Imaging is today submitting a special application to the FDA for a higher frame-rate version, which takes 14 frames per second. The company has already launched this enhanced, higher frame rate PillCam ESO in Europe and will launch in the US pending clearance from the FDA. Given Imaging CFO Yoram Ashery says the FDA procedure for the faster camera is a technical matter, and the nod should be forthcoming in about a month.
A faster camera is necessary because the capsule spends all of about ten minutes in the esophagus, whereas its tour of the intestine takes hours, Ashery explained. The focus on the lower part of the esophageal passage can help detect cancer at early stages, he added.
Following FDA clearance of the 14 frame per second PillCam, Given Imaging says it means to upgrade its installed base with its RAPID 3 image processing software and an enhanced data recorder. This upgrade will make the existing installed base compatible with the new capsule and allow existing customers to obtain the full benefits of the new capsule, the company said.
The PillCam ESO will be commercialized through the alliance with InScope, a division of Ethicon Endo-Surgery, Inc., a Johnson and Johnson company, which was signed between the companies in May 2004.
The results of a multi-center pivotal study of 106 patients demonstrated the PillCam ESO video capsule’s comparable efficacy to conventional endoscopy in visualizing esophageal pathology. Interim results of the first 80 patients from the pivotal trial were recently presented at the 12th United European Gastrointestinal Week in Prague, Czech Republic.
The interim analysis showed 97% sensitivity and 100% specificity for the PillCam ESO video capsule in detecting pathology in patients with chronic gastro-esophageal reflux disease (GERD) symptoms. The investigators found the PillCam ESO video capsule to be a convenient, safe and sensitive method for detecting esophageal lesions and suggested that it could be an effective tool for screening patients with esophageal disorders such as chronic GERD symptoms to detect visual signs of Barrett’s esophagus, a pre-cancerous condition.
According to the Wall Street Journal, this technological innovation has come along just in time.
“An epidemic of heartburn has triggered an alarming rise in a deadly cancer, but many people at risk still aren’t being screened for the disease. Esophageal adenocarcinoma is strongly linked to chronic heartburn and acid reflux. And it is now the fastest growing cancer in the country.The incidence of the disease has surged five-fold in three decades.”
The PillCam ESO is a twin-camera esophageal video capsule that transmits antegrade and retrograde images simultaneously. It is specially-designed to visualize the esophageal mucosa and provides a lessinvasive approach to traditional endoscopy.
How does it work? The PillCam ESO is ingested in supine position with a small glass of water; image transmission begins. The Patient can then gradually rise at specified intervals to sitting position, after which patient can sit in the waiting room. After approximately 20 minutes, the PillCam ESO passes naturally through the GI tract. The physician reviews the video at a convenient time and place.
In addition to esophageal CE, other emerging indications and applications include
using Capsule Endoscopy for patients with complicated celiac disease and medication-induced injury.