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Crospon announces FDA 510k clearance of lighted version of EndoFLIP catheter, the EF-325L

29th July 2013

Crospon today announced that it has received FDA 510k clearance to market its new EF-325L lighted EndoFLIP catheter. The catheter has a centrally located red LED which allows the location of the central electrode position of the balloon to be seen through tissue. This is particularly advantageous during per-oral endoscopic myotomy (POEM), since it allows the location of the gastro-esophageal junction to be identified through the wall of the esophagus, so that when the endoscope is sitting in the tunnel fabricated inside the wall of the esophagus during POEM, the surgeon or gastroenterologist can identify the GEJ landmark, which serves as an important landmark to guide where the myotomy should stop. Similarly, during fundoplication or Heller Myotomy surgery, the light permits the surgeon to identify the location of the catheter within the esophagus or stomach, as the light on the catheter shaft may be observed by the laparoscope. The catheter will be available for shipment from October 2013.

The EF-325L catheter
The EF-325L catheter

 

 
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