SAN DIEGO, Oct. 16, 2013 (GLOBE NEWSWIRE) -- Given Imaging (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced results from multiple studies that showed the positive impact of ManoScan® high resolution manometry and Bravo® pH monitoring in measuring esophageal dysfunction and the severity of symptoms including dysphagia, chest pain and reflux. The studies were presented during the American College of Gastroenterology's 2013 Annual Scientific Meeting (ACG), taking place October 11-16, 2013 in San Diego, California where Given Imaging is exhibiting at booth #1200 throughout the conference.

Highlights of key studies presented at ACG include:

  • Repeat esophageal manometry positively impacts diagnostic management in 57.6% of patients
  • ManoScan provides valuable insights about opioid induced esophageal dysfunction, a condition for which limited data was previously available
  • High resolution manometry finds a higher rate of achalasia in African American women as compared to other races/ethnicities in the largest multi-ethnic cohort evaluated to date
  • Bravo pH monitoring helps redirect care in 95% of patients with esophageal symptoms who didn't respond to high dose PPI therapy

"Determining the correspondence between esophageal disorders and their underlying causes can be difficult due to the overlapping symptoms of many gastrointestinal conditions," said John Pandolfino, M.D., Chief, Division of Medicine-Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine. "Using ManoScan high resolution manometry and Bravo pH monitoring, we can now pinpoint the underlying causes of a patient's symptoms, determine a patient's condition, and tailor therapies to ultimately improve patient outcomes." 

Dr. John Pandolfino and colleagues at Northwestern University, presented poster #P29, "The Natural History of Esophagogastric Junction Outflow Obstruction and Treatment Outcomes," and discussed how patients with this condition, as diagnosed by high resolution manometry, present with dysphagia as the predominant symptom (46%), followed by chest pain (32%), heartburn (20%), or nausea and vomiting (19%). More patients reported improvement in symptoms with treatment, but additional prospective studies are needed to evaluate the effect of different treatment modalities on patient outcomes.

In addition, high resolution manometry was also evaluated in specific patient sub-populations including the elderly and chronic opioid users. In poster #P1216, "Alterations in Esophageal Function on High Resolution Esophageal Manometry in the Elderly," Steven DeMeester M.D., and colleagues at the Keck School of Medicine of the University of Southern California performed an analysis of 164 patients who underwent high resolution manometry and found that abnormal peristaltic breaks were observed in more patients over 70 years of age (44% vs. 10%) and were more common in patients with GERD and dysphagia symptoms. The authors noted that the decline in esophageal body function with age did not appear to be related to the severity of GERD and should be considered when discussing treatment options and expected outcomes in patients 70 years or older.

To further validate the high resolution manometry's clinical utility, in poster #P24, "The Utility of Repeat Esophageal Manometry," Brian Lacy M.D., and colleagues at Dartmouth-Hitchcock presented a retrospective review of 132 patients who underwent at least two consecutive esophageal manometry tests. The team found value in repeat testing, noting it led to a change in diagnosis in 57.6% of patients. A higher rate of new diagnosis (67%) was also found in patients who presented with a change of indication between their first and second test and the authors concluded that repeating esophageal manometry should be considered if symptoms of dysphagia or chest pain persist or if symptoms change over time. In poster #P611, "Opioid Induced Esophageal Dysfunction (OIED) in Chronic Opioid Users," Shiva Ratuapli M.D. and colleagues from Mayo Clinic Arizona evaluated the impact of opioid use on bowel dysfunction and motility. A retrospective review of the motility database identified 123 chronic opioid users, with 67 patients reporting being current users and 56 patients reporting no opioid use in the prior 24 hours. Investigators used ManoScan high resolution manometry and conducted an analysis with ManoView software 3.0. The Chicago classification system, the industry's standardized categorization scheme for identification of motility disorders, was used to characterize esophageal dysmotility. The study found that opioid induced esophageal dysfunction was present in both chronic and current opioid users and that patients taking opioids within 24 hours of manometry exhibited more frequent outflow obstruction and spastic dysmotility patterns compared with those who stopped opioid use for at least 24 hours prior to the study.

Poster #P613, "Effect of Race and Ethnicity on the Clinical Presentation, Treatment Decisions and Treatment Outcomes for Patients with Achalasia Defined by the Chicago Classification," presented by Elizabeth Rosenblatt M.D., and colleagues from Johns Hopkins, conducted a retrospective review of 1,268 patients that utilized the Chicago Classification of Esophageal Motility and high resolution manometry to meaningfully subgroup patients with achalasia. In this largest known cohort assembled to address racial and ethnic disparities in the use of high resolution manometry and manometric standards, the researchers found that a higher percentage of women presented with achalasia in African Americans as compared to other race/ethnicity groups. They also found that treatment decisions and outcomes were similar across all groups.

In looking at the impact of pH monitoring in evaluating esophageal symptoms both on and off PPI therapy, "Four-Day Two-Phase Wireless pH Monitoring for Evaluation of Esophageal Symptoms Refractory to High Dose PPI: Utility in Clinical Practice", poster #P14 was presented by Louis Wilson, M.D., Wichita Falls Gastroenterology Associates, Wichita Falls, Tex. Forty-two patients with esophageal symptoms who were not responding to high dose PPI therapy underwent Bravo pH monitoring for up to 88 hours. Results for pH monitoring contributed to redirecting care in 95% of patients, including eliminating PPI use in 15 patients and delivering new diagnoses in 12 patients. Bravo pH monitoring successfully identified GERD in 32 patients.

About ManoScan high resolution manometry

Given Imaging pioneered ManoScan high resolution manometry, the first high resolution manometry system. ManoScan system continues to remain the market leader in comprehensive solutions for assessing gastrointestinal motility. ManoScan is the only system with automatic findings incorporated into the Chicago Classification algorithms, a standardized categorization system for identifying and classifying motility disorders. Through the combination of proprietary tactile-sensing catheter technology and easy-to-use ManoView® software, ManoScan reveals complex functional anatomy, enabling physicians to more accurately diagnose abnormalities of the gastrointestinal tract.

Manometry products have certain risks associated with catheter insertion. Medical, endoscopic or surgical intervention may be necessary to address complications, should they occur. These systems are not compatible for use in an MRI magnetic field.

About Bravo pH monitoring

Bravo pH monitoring is the only catheter-free pH test. The procedure uses a pH capsule that is temporarily attached to the wall of the esophagus to wirelessly transmit pH data continuously for up to 96 hours. Like catheter-based pH tests, the Bravo pH monitoring system is an ambulatory method of pH monitoring, considered the gold standard for pH measurement and monitoring of gastric reflux. The Bravo pH monitoring system collects data that are more reflective of the patient's normal daily routine to assess if the patient has GERD.

The risks of Bravo pH monitoring include: premature detachment, discomfort, failure to detach, failure to attach, capsule aspiration, capsule retention, tears in the mucosa, bleeding, and perforation. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. Because the capsule contains a small magnet, patients should not have an MRI study within 30 days of undergoing the Bravo pH test.

About Given Imaging Ltd.

Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan® high resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z monitoring, and SmartPill® motility monitoring systems. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam, Hong Kong and Brazil. For more information, please visit givenimaging.com.

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