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Clinical Practice Update Issued by the AGA Institute for Crospon's Functional Lumen Imaging Probe (FLIP®)

Galway, Ireland: March 1, 2017

The American Gastroenterology Association (AGA) Institute Clinical Practice Updates Committee (CPUC) has issued a clinical practice update and expert review of the functional lumen imaging probe (FLIP®).

The clinical practice update, published in the March issue of Clinical Gastroenterology and Hepatology, gives advice on five areas of best practice for the Food and Drug Administration (FDA) cleared measurement tool used to guide management of various upper gastrointestinal disorders. The FLIP® is indicated for use with an endoflip® system in a clinical setting to measure pressure and dimensions in the esophagus, pylorus and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. It is also used to guide therapy during bariatric procedures and specialized esophageal surgery.

The clinical practice update describes the technique and reviews the potential indications in achalasia, EoE and GERD, making the following 'Best Practice Advice Statements':

  1. Best Practice Advice Statement 1: Clinicians should not make a diagnosis or treatment decision based on function lumen imaging probe (FLIP®) assessment alone;
  2. Best Practice Advice Statement 2: FLIP® assessment is a complementary tool to assess esophagogastric junction (EGJ) opening dynamics and the stiffness of the esophageal wall;
  3. Best Practice Advice Statement 3: Utilization should follow distinct protocols and analysis paradigms based on the disease state of interest;
  4. Best Practice Advice Statement 4: Clinicians should not utilize FLIP in routine diagnostic assessments of gastroesophageal reflux disease (GERD);
  5. Best Practice Advice Statement 5: FLIP® should not be used to diagnose eosinophilic esophagitis (EoE) but may have a role in severity assessment and therapeutic monitoring.

The best practice update notes: "The evolution of esophageal function testing has moved rapidly over the last 10 years along the continuum of manometric technique and bolus transit assessment. FLIP® offers an innovative method that enhances the assessment of esophageal function in various diseases including the management of achalasia. Emerging evidence also supports the clinical relevance of FLIP in assessing disease severity and measuring outcomes in EoE. We recommend that further evaluation is required in the application of FLIP® to GERD interventions targeting the EGJ and other foregut disorders."

The AGA Institute Clinical Practice Updates Committee is charged with providing authoritative and balanced articles for Gastroenterology and Clinical Gastroenterology and Hepatology.

"We acknowledge and welcome the role the AGA Institute is playing in updating the Gastroenterology profession on new technologies by providing objective clinical assessment in these clinical practice updates. We agree that FLIP® technology, which is at the core of Crospon’s endoflip® imaging system, is a complementary tool to assist clinicians in diagnosis, particularly in conjunction with endoscopy", said John O'Dea, CEO and Founder of Crospon.

"We would concur that there is more work needed to progress the use of FLIP® in GERD diagnostics, however, but would note that intra-operative use of the technology in GERD surgery is more advanced. While not a diagnostic tool for clinicians in cases of suspected EoE, endoflip® has a role to play in measuring the response of the esophagus to treatment, particularly where there is a narrowing due to fibro-stenosis and in predicting the risk of food impaction."

The clinical practice update also concluded that more work is needed which focuses on optimizing data analytics, standardizing protocols, and defining outcome metrics.

John O'Dea agreed, adding: "We think that is a fair comment presently but developments on further analysis and reporting modules are in progress. The introduction of real-time FLIP® Topography and analytics of maximal esophageal diameter in future software updates along with additions to our endoflip® product line later this year will address a number of these issues."

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