H.4 Over the Scope large dilator balloon

Esophageal dilatation is a common procedure with high therapeutic yield in most circumstances. Most of these are performed during endoscopy. The most convenient and endoscopist friendly type of balloon is a through the scope (TTS) balloon, but these are limited in their maximal size due to need to fit through the endoscope channel port. Maximal diameter of these balloons when expanded is 20 mm (see Boston Scientific CRE balloon). There are multiple clinical scenarios when a larger balloon (20 or more, up to 35 mm) is needed – achalasia, EGJOO (Boston Scientific Rigiflex Pneumatic Balloons). And this area of need is expanding. Typically these are problems of the esophageal smooth muscle. Due to these constraints, the only way to perform these dilations is with cumbersome, wire guided techniques which require special training / equipment (fluoroscopy) thus are only performed by few. If an over the scope balloon was developed which could be done in the standard endoscopy setting and dilate up to 35 mm this would solve these problems. Would need to be rigid as to dilate the esophagus.