FDA clears expanded indications for EndoFLIP endolumenal imaging system
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The FDA has cleared expanded indications for the EndoFLIP endolumenal imaging system, the manufacturer announced.
In addition to currently cleared indications for the esophagus and stomach, the EndoFLIP (Crospon) system and catheters can now be used for sphincter measurements in patients with disorders like gastroparesis and fecal incontinence, according to a press release.
CMS began providing payments for the use of EndoFLIP in the esophagus under CPT code 91040 effective at the beginning of the year.
“This product clearance permits Crospon to participate in new and large gastrodiagnostic market segments,” John O’Dea, CEO of Crospon, said in the press release. “We are continuing to add exciting new functionality to our EndoFLIP platform which soon, uniquely, will allow gastroenterologists to 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.”
Eleven poster presentations on EndoFLIP technology will be featured at DDW in San Diego later this month, he added.
Disclosure: O’Dea is employed by Crospon.