Galway-headquartered Crospon has received FDA clearance for its EF-800 external channel endoscopic accessory. This is the latest output in the collaborative development programme between Crospon and Israeli medical device developer Smart Medical announced in April 2011.
The device provides an external 4mm channel which can be applied to a diagnostic or therapeutic endoscope to allow the user to deploy endoscopic accessories whose diameter exceeds the typical channel diameter of such endoscopes.
“This general purpose channel may be used to deploy the company’s EndoFLIP catheters into hard-to-access parts of the gastrointestinal tract, for example for measurement of stomas in the stomach created during bariatric surgery procedures,” John O’Dea, CEO, Crospon, said.
“Equally, it will be useful for a variety of other endoscopic accessories, for example larger dilation catheters, graspers or imaging probes.”
At the start of 2011, the company announced it has received clearance from the US Food and Drug Administration (FDA) to market a new imaging catheter for the measurement of sleeves created during bariatric surgery.
In July 2011, the company received clearance from the FDA and a CE mark to market its new EndoFLIP EF-900 Gastric Tube.