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FDA Clearance Received For Barostat Option

Wed, 08/29/2012 - 7:58am

(BUSINESS WIRE)--Crospon, a medical device developer based in Galway, Ireland has announced that it has received FDA clearance for the first use of its EndoFLIP system in gastroenterology applications.

The newly cleared Barostat software option extends the FDA cleared uses for the EndoFLIP system beyond measurements taken during gastric band and sleeve gastrectomy bariatric surgery procedures, to now include pressure and dimension measurements taken in the esophagus and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity. All new EndoFLIP systems will include the Barostat software option.

Commenting on the FDA clearance, John O’Dea, CEO, Crospon said, “This clearance is important for Crospon as it, for the first time, allows us to market the EndoFLIP system in the USA for gastroenterology applications. Not only is this the Company’s first cleared application for gastroenterology, but it also represents the first reimbursed application for the product”

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