Crospon gets FDA nod for next-gen endoscopic imaging platform

FDA
Crospon's next-gen Endoflip offers clinicians a new way to assess patient motility disorders during endoscopy.

Galway, Ireland-based Crospon earned FDA clearance for its second-generation imaging software that provides an internal view of the junction where the esophagus and the stomach meet.

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

The system is designed to be used alongside other diagnostic tools in the assessment of patients with gastrointestinal motility disorders. In the case of esophageal disease, the device helps physicians evaluate the mechanical properties of the esophageal wall as well as the way the gastroesophageal junction opens.

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The next-generation Endoflip System with Flip Topography Module displays contractility patterns of the esophagus in real time, Crospon said in a statement. The system allows gastroenterologists to look for achalasia—which can cause the sphincter to remain closed during swallowing—and other disorders of peristalsis during endoscopy, the company said.

Esophageal motility disorders are not uncommon, according to Medscape. In addition to achalasia, these include spastic motility disorders, such a diffuse esophageal spasm and secondary esophageal motility disorders, which result from other diseases such as diabetes and scleroderma.

“The standout benefit of this application, for both patients and caregivers, is that the FlipTopography assessment can be performed in less than five minutes during upper endoscopy on a sedated patient,” said CEO John O’Dea. “In addition to significantly reducing discomfort, the patient may not have to wait for testing at a specialized center, thereby reducing their time to treatment. While not always a substitute for manometry, Endoflip 2.0 can reveal situations of non-obstructive dysphagia which may benefit from further evaluation from manometry.”

Crospon plans to start shipping the new system in June.

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