Crospon Reports – First Gastric Imbrication Procedures Conducted With EndoFLIP

Reversible weight loss surgery to become procedure of choice

CARLSBAD, Calif. & GALWAY, Ireland--(BUSINESS WIRE)--Crospon, an Irish medical device developer has today announced that its EndoFLIP^® http://www.endoflip.com/ system has been used for the first time to assist in the sizing of a gastric sleeve in the newly emerging weight loss surgery technique known as gastric imbrication.

“We believe that this is a very innovative use for the EndoFLIP® technology, and that it fills an important need for the gastric imbrication procedure, namely providing visual feedback to the surgeon as to the size of sleeve being created”

Unique as a weight loss procedure, gastric imbrication is a reversible procedure with no device required to be implanted and no stomach tissue removed. With over 200,000 people engaging in surgical weight loss procedures annually in the United States the appeal and potential for such a procedure is significant.

Crospon participated as part of a randomized control trial currently underway with principal investigators Mahendra Narwaria MS, FICS (Asian Institute of Gasroenterology Surgery, Ahmedabad, India), Daniel R. Cottam M.D. (Surgical Weight Loss Centre of Utah), and Sunil Sharma, M.D (University of Florida), to compare weight loss outcomes of gastric imbrication versus sleeve gastrectomy.

Commenting, Dr. Daniel Cottam said “The EndoFLIP^® device has the ability to change the way we do bariatric surgery all over the world. There has been nothing as revolutionary as this device since the lap band. I believe in five years we won’t know how we ever did bariatric surgery without it”.

In the case of sleeve gastrectomy a significant portion of the stomach is surgically removed during the weight loss procedure, whereas with the gastric imbrication procedure no stomach tissue is removed. The Cottam technique represents an enhancement to the gastric imbrication procedure which entails the placing of an EndoFLIP^® catheter along the lesser curve of the stomach during the procedure.

This permits the surgeon to precisely stitch the stomach to give a desired sleeve diameter. For example, in the case of a bariatric revision procedure, it may be desirable to create a 20mm diameter sleeve where the objective might be weight loss maintenance, whereas in the case of a primary bariatric procedure, a 13mm diameter sleeve could be created to promote weight loss.

Commenting on the new Cottam technique, John O’Dea, CEO, Crospon, said, “We believe that this is a very innovative use for the EndoFLIP^® technology, and that it fills an important need for the gastric imbrication procedure, namely providing visual feedback to the surgeon as to the size of sleeve being created”.

The Hospital Angeles, in Tijuana, Mexico under the control of Dr. Juan Antonio Lopez Corvala and his team will be conducting training on the Gastric Imbrication surgical technique in June using the Crospon EndoFLIP^® to create the sleeve during the procedure.

Larry Fulton V.P. of Sales, Crospon, commented, “This is truly breakthrough technology to allow the surgeon to create a “custom sleeve” to avoid post-operative complications. It is a perfect marriage of a new procedure and a new technology to benefit patients and to give more consistent surgical outcomes.”

About Crospon

Established in 2006, Crospon is a medical device company focused on the monitoring and treatment of gastroesophageal reflux disorder (GERD). Company co-founder and CEO, John O’Dea, previously co-founded Caradyne, a respiratory products company which was acquired by Respironics Inc in 2004.

In January, Crospon announced the completion of a €2 million round of funding and that the Company’s flagship gastroenterology product, EndoFLIP^® had received clearance from the US Food and Drugs Administration (FDA). Obtaining FDA clearance for the EndoFLIP^® device is another significant milestone in the product’s development. This clearance will permit the company to sell EndoFLIP^® in the U.S. market and assist Crospon in continuing to build the clinical evidence base to support wider indications for use of EndoFLIP^®, particularly in the bariatric surgery area. During 2009, Crospon announced the establishment of a US operation in Carlsbad, California.

In 2008, Crospon announced that it had completed an additional funding round of €3.5m. This funding was primarily used for the completion of development, manufacturing start-up and preparation to market of the EndoFLIP^® system.

Crospon received the Overall Medical Technology Excellence Award and the Gold Award for Innovation and Research and Development at the 2009 Irish Medical Device Association Awards and recently won the Innovator of the Year Award at the Irish Small Firms Association National Business Awards 2010.