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Crospon receives expanded indications from FDA for EndoFLIP Catheter

5th May 2016 - Galway, Ireland

New technologies to be showcased at Digestive Diseases Week (DDW) in San Diego this month

Crospon has today announced that it has received clearance from the US FDA for expanded indications of use for its EndoFLIP® endolumenal imaging system. The system and catheters are now cleared for use in sphincter measurements in patients with such disorders as gastroparesis and fecal incontinence. These new indications expand the use of EndoFLIP beyond the esophagus and stomach. The US Centers for Medicare and Medicaid Services (CMS) have begun providing payments for the use of EndoFLIP® in the esophagus under the current procedure terminology (CPT) code 91040, which became effective on January 1, 2016.

Commenting on the FDA clearance, John O'Dea, CEO, Crospon said, "This product clearance permits Crospon to participate in new and large gastrodiagnostic market segments. We are continuing to add exciting new functionality to our EndoFLIP® platform which soon, uniquely, will allow gastroenterologists assess swallow function during endoscopy, permitting a higher diagnostic yield from a single endoscopy session, potentially reducing time to treatment, and significantly improving patient comfort. We look forward to sharing the progress in this area at DDW, which this year features eleven poster presentations on EndoFLIP technology".

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