Crospon, out of Galway, Ireland, recently received Frost & Sullivan’s 2009 European Gastroenterology Technology Implementation of the Year Award for the Endoflip device. The Endoflip delivers a balloon catheter to the gastroesophageal sphincter, a junction between the esophagus and stomach, and can test the strength of the muscles controlling its closure. Already approved in the EU, the company is seeking FDA’s approval for the US market.
From the manufacturer:
Crospon has addressed the need for a GERD-focussed diagnostic platform by developing an integrated solution which facilitates real-time imaging of the lower esophageal sphincter in less than 10 minutes. The EndoFLIP® system constitutes a set of 16 electrodes that sit within a balloon catheter which is attached to a data recorder with a touch screen. This series of electrodes is capable of measuring resistance or impedance to calculate cross-sectional areas at different points along the balloon. At the commencement of the procedure, the deflated balloon catheter is attached to a prefilled syringe, which is inserted into the syringe pump on the front of the EndoFLIP® tool. Subsequently, the deflated balloon is then passed trans-orally or trans-nasally to the gastroesophageal junction whereby it permits a challenge test to the lower esophageal sphincter to determine its functionality.
The scientific principle behind EndoFLIP®’s implementation is impedance planimetry. This is a technique that can measure cross-sectional area electrically which in turn enables 16-slice display images. This display shows the changes in the estimated diameters of sphincteric regions in the body in real time, thereby permitting a real time image of the geometry in vivo of the human esophagus to be obtained. Crospon has submitted an application to the FDA for EndoFLIP®’s clearance in the US market. The company has already received CE mark certification from the National Standards Authority of Ireland.
Video below fold demonstrating the placement of the device:
Press release: 2009 European Gastroenterology Technology Implementation of the Year Award…
More literature about the device…