FDA grants marketing clearance to Crospon's EndoFLIP product

Jan 6 2011

Crospon, an Irish medical device developer based in Galway, has announced that the Company 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.

The catheter which will be launched at the SAGES 2011 Conference in San Antonio in March is the latest development to the Company's EndoFLIP^® range and is designed to assist surgeons during sleeve gastrectomy and gastric imbrication procedures.

Explaining the benefits of the new catheter product, John O'Dea, CEO, Crospon said, "We continue to see positive results with the intra-operative use of EndoFLIP^® during gastric banding. By providing surgeons for the first time with an ability to measure the size of the sleeve they are creating, in real time during surgery, we believe it can increase the safety profile of the procedure by ensuring that the sleeve is not created too small, which in turn reduces the risk of leaks."

Crospon develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area. During 2010 Crospon launched its EndoFLIP^® product in the U.S. market at the 12th World Congress of Endoscopic Surgery in National Harbor, Washington DC. The EndoFLIP^® product which received FDA clearance in December 2009 is the first product of its kind, which allows a bariatric surgeon to measure and set a consistent gastric band stoma size during surgery.

Continuing John O'Dea said, "We are pleased to have received this latest clearance from the FDA, as it allows us to now engage in the fast growing sleeve gastrectomy bariatric market segment. The recent trend is to make sleeves tighter to improve weight loss trajectory. This makes visualisation of the sleeve diameter even more important since the risk for a restriction in the sleeve is higher at such small diameters."

Larry Fulton, VP Sales for the Americas, Crospon emphasized the relevance of the new EndoFLIP^® imaging catheter for bariatric surgeons, "We are seeing a growing interest in the EndoFLIP^® system to assist surgeons performing the newly emerging gastric imbrication sleeve procedure. Whereas this newer emerging sleeve procedure is less invasive by virtue of no stomach being removed, the very fact that the stomach is kept intact presents an added challenge for the surgeon in measuring the size of the sleeve being created. We believe that the ability to measure the size of the sleeve will be an essential element in creating appropriately sized sleeves safely and consistently during gastric imbrication surgery."

Source: Crospon