Crospon, a Galway, Ireland company, has received FDA 510(k) approval for the EsoFlip Dilation Catheter. The EsoFlip catheter is intended to be used to dilate the colon or the esophagus (not at the same time, in case you wondered). The company’s first product was the EndoFLIP (Endolumenal Functional Lumen Imaging Probe) Imaging System, which is used to measure the dimensions and functional measures of viscus organs, vessels and sphincteric structures in the body. Unlike the EndoFlip product, which is used as a measurement tool, the EsoFlip catheter will signal Crospon’s entry into the therapeutic endoscopy accessory market.
The first EsoFlip catheter, ES330, is a 30mm balloon dilation catheter deployed using a 0.035″ guide wire, that works in conjunction with the EndoFlip system to inflate and dilate the gastroesophageal junction in patients with achalasia (an esophageal motility disorder). 14 electrodes on the EsoFlip catheter provide electrical data regarding the lumen diameter during inflation. During the inflation and dilation process, diameter measurements can be viewed on the EndoFlip screen and the dilation process can be continued until the displayed diameter matches the target dilation. This ability to view real time diameter data on the screen eliminates the requirement for fluoroscopy during balloon dilation that could lead to unnecessary radiation exposure for the patient and the physician. The ES330 catheter is 9 Fr. in size with an 8 cm balloon length and 2.4 meter working length.