Crospon, the Galway-based medical device developer, has got clearance from the US Food and Drugs Administration (FDA ) to market a new imaging catheter for the measurement of sleeves created during bariatric [weight loss] surgery.
The catheter, which will be launched at the SAGES 2011 Conference in San Antonio in March, is the latest development in the company’s EndoFLIP® range. It is designed to assist surgeons during sleeve gastrectomy and gastric imbrication procedures.
Explaining the benefits of the new catheter product, John O’Dea, the chief executive of Crospon, says it continues 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.”
He says the company is pleased to have received this latest clearance from the FDA because it allows Crospon to 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, vice president for sales for the Americas Crospon, emphasised 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.”
Crospon, which was set up in 2006, develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area. It launched its EndoFLIP® product - the first of its kind which allows a bariatric surgeon to measure and set a consistent gastric band stoma size during surgery - in the US market at the 12th World Congress of Endoscopic Surgery in National Harbor, Washington DC in 2010. It received FDA clearance in December 2009.
During September 2010 Crospon announced results of a study presented at the 15th Annual Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders in Long Beach, CA. The study, which took place at the Speciality Surgery Center of Fort Worth, TX, a Center of the AIGB True Results clinical network - the largest gastric band placement network in the world - demonstrated that 30 per cent of patients measured achieved greater than 30 per cent excess weight loss in the four to six week period after surgery. Even though they had a band adjustment during surgery none required their band to be loosened in the post-operative period.
