Irish medical device developer Crospon has been cleared by the Food and Drug Administration (FDA) to market its EndoFLIP imaging system in the US for gastroenterology applications.
The Galway-based company itself was set up in 2006 and it is developing medical devices for imaging with the aim of helping surgeons carry out more minimally invasive procedures in the esophagus and stomach.
The EndoFLIP imaging system is the first product that Crospon is bringing to market.
According to the company, the system will be able to be used in gastrodiagnostics and bariatric surgery and to measure the dimensions in other hollow organs such as the stretching capacity of sphincters and valves.
Crospon’s CEO John O’Dea said that the FDA clearance is significant, as it will allow the company to market EndoFLIP in the US for gastroenterology applications for the first time.
"Not only is this the company’s first cleared application for gastroenterology, but it also represents the first reimbursed application for the product," he said.
Crospon had added a new Barostat software option to EndoFLIP. Apparently this new option extends the FDA cleared uses for the EndoFLIP system beyond measurements taken during gastric band and sleeve gastrectomy bariatric surgery procedures. For instance, it means that EndoFLIP can also include pressure and dimension measurements taken in the esophagus.