Author: Shaina R. Eckhouse, MD
Crospon Ltd., now a Medtronic company, received FDA approval in April 2017 for the EndoFLIP System with FLIP Topography Module.
The EndoFLIP system centers on a single-use catheter that is employed to measure the distensibility within a gastrointestinal (GI) organ. The measurement of distensibility is a ratio of the dimensions and the pressure inside the GI organ undergoing examination. The distensibility measurement can be used as an adjunctive test to understand GI pathology and provide information during motility evaluations and diagnostic examinations of GI disorders. The device also has a display functionality software module called FLIP (functional luminal imaging probe) Topography.
Most commonly, the EndoFLIP system is utilized during an upper endoscopy while a patient is sedated. The catheter associated with the EndoFLIP system is passed into the esophagus. Fluid is injected through the catheter to fill a balloon that contains special electrodes that measure voltages, which helps to estimate both diameter and pressure. The addition of EndoFLIP to a standard upper endoscopy adds approximately 10-15minutes.
The EndoFLIP system has been studied for use in the setting of multiple GI disease processes including both foregut and hindgut pathology. Specifically, uses of the EndoFLIP system include to improve success of both GERD and achalasia surgery, to augment endoscopic dilations, and to guide placement of gastric bands and examine intraluminal distensibility of the stomach after sleeve gastrectomy, as well as to optimize anal canal and anal sphincter evaluations.
FDA approved indications for use:
- For use in the clinical setting to measure pressures and dimensions in the esophagus, stomach, and anus. The EndoFLIP system is intended as an adjunctive diagnostic test in patients with GI motility disorders.
- For use to estimate the size of a gastric band stoma during placement.
- For use as an adjunct to a bougie during the bariatric surgical procedure, a laparoscopic sleeve gastrectomy. It is suitable for sleeve gastrectomy operations performed with 22 to 60F bougies.
- If endoscopy is contraindicated, then the EndoFLIP system is contraindicated.
- The EndoFLIP system is contraindicated in the setting of bleeding esophageal varices.