Galway-based medical device firm Crospon has this week announced that it has received clearance from the Food and Drug Administration (FDA ) in the US 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 bariatic surgery procedures. Its uses can now include pressure and dimension measurements taken in the oesophagus and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with oesophageal sensory hypersensitivity. All new EndoFLIP systems will include the Barostat software option.
“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,” said John O’Dea, CEO of Crospon.
Crospon, which is located at Galway Business Park, Dangan, was established in 2006. It was recently awarded the 2012 European Enabling Technology Award for surgical imaging technology by Frost & Sullivan.