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Crospon receives FDA clearance for External Channel endoscopic accessory

Market launch for EF-800 device anticipated by year end

Wednesday 19th October 2011

Irish medical device developer, Crospon has today announced that it has received FDA clearance for its EF-800 external channel endoscopic accessory. Market launch is anticipated in December 2011.

The device provides an external 4mm channel which can be applied to a diagnostic or therapeutic endoscope to allow the user deploy endoscopic accessories whose diameter exceeds the typical channel diameter of such endoscopes. This is the latest output in the collaborative development programme between Crospon and Israeli medical device developer Smart Medical announced in April 2011.

Commenting on the FDA clearance, John O’Dea, CEO, Crospon said, “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. Equally it will be useful for a variety of other endoscopic accessories, for example larger dilation catheters, graspers or imaging probes.”

Crospon develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area.

At the start of 2011, the Company announced it has received clearance from the US Food and Drugs 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 US Food and Drugs Administration (FDA) and a CE mark to market its new EndoFLIP® EF-900 Gastric Tube. This is intended for use in bariatric surgical procedures to provide a sized support bougie for sleeve gastrectomy, and to permit stomach decompression, gastric fluid drainage and removal. It can also be used to aid deployment of the company’s range of EndoFLIP catheters within the esophagus and stomach.

Crospon’s John O’Dea is a finalist in the 2011 Irish Ernst & Young Entrepreneur of the Year competition.



 
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EndoFLIP logo   Crospon Inc. 701 Palomar Airport Rd, Carlsbad, CA 92011, USA. Phone: 1-855-CROSPON
Crospon Ireland. Galway Business Park, Dangan, Galway, Ireland Phone: +353-91-519880