FDA grants 510(K) approval for Endoflip System with Flip Topography Module, offering a new way for clinicians to assess patient motility disorders during endoscopy.- Crospon

Crospon, an endoscopic diagnostics company, announced it has received FDA 510(k) clearance for its Endoflip System with Flip Topography Module, providing a new way for clinicians to assess patient motility disorders during endoscopy. Shipments of Endoflip 2.0 systems will commence in June 2017.

Crospon�s Endoflip system and its catheters were previously cleared to measure pressure and dimensions in the esophagus, pylorus and anal sphincters.

The next generation of the Endoflip System, Endoflip 2.0, introduces imaging software that displays real-time esophageal contractility patterns on a 24� touch-screen. The unique repetitive visual cues of the patented Endoflip technology enables gastroenterologists, for the first time, to investigate for conditions such as achalasia, GEJ outflow obstruction and other major or minor disorders of peristalsis during endoscopy. EndoFLIP 2.0 also introduces the new capability to capture and store Endoflip images in electronic patient records.

A clinical practice update, issued by the American Gastroenterological Association (AGA) Institute this March 2017, supports the use of Endoflip as an innovative method of enhancing the assessment of esophageal function in various diseases, including the management of achalasia, and in assessing disease severity and measuring outcomes in eosinophilic esophagitis. (EoE). Flip or functional luminal imaging probe technology is at the core of the Endoflip imaging system being developed by medical device company Crospon, headquartered in Galway, Ireland. Flip uses high-resolution impedance during volume-controlled distention to measure luminal geometry and pressure and to assess the mechanical properties of the esophageal wall and opening dynamics of the esophagogastric junction (EGJ) in various esophageal diseases.