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Crospon Receives FDA Clearance for External Channel Endoscopic Accessory


10/19/2011 6:33:01 AM

19th October 2011 – Galway Ireland, Irish medical device developer, Crospon has today announced that it has received FDA clearance for its EF-800 external channel endoscopic accessory. Market launch is anticipated in December 2011.

The device provides an external 4mm channel which can be applied to a diagnostic or therapeutic endoscope to allow the user deploy endoscopic accessories whose diameter exceeds the typical channel diameter of such endoscopes. This is the latest output in the collaborative development programme between Crospon and Israeli medical device developer Smart Medical announced in April 2011.

Commenting on the FDA clearance, John O’Dea, CEO, Crospon said, “This general purpose channel may be used to deploy the company’s EndoFLIP catheters into hard to access parts of the gastrointestinal tract, for example for measurement of stomas in the stomach created during bariatric surgery procedures. Equally it will be useful for a variety of other endoscopic accessories, for example larger dilation catheters, graspers or imaging probes.”

Crospon develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area.

At the start of 2011, the Company announced it 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.

In July 2011 the Company received clearance from the US Food and Drugs Administration (FDA) and a CE mark to market its new EndoFLIP® EF-900 Gastric Tube. This is intended for use in bariatric surgical procedures to provide a sized support bougie for sleeve gastrectomy, and to permit stomach decompression, gastric fluid drainage and removal. It can also be used to aid deployment of the company’s range of EndoFLIP catheters within the esophagus and stomach.

Crospon’s John O’Dea is a finalist in the 2011 Irish Ernst & Young Entrepreneur of the Year competition.

For Further Information please contact

John McGuinness

Murray Consultants

jmcguinness@murrayconsult.ie

00353 1 498 0361

00353 87 6417451

www.endoflip.com

About Crospon

Established in 2006, Crospon is a medical device company focused on delivering leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area. Company co-founder and CEO, John O’Dea, previously co-founded Caradyne, a respiratory products company which was acquired by Respironics Inc in 2004. 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.

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 (IFSO 2010), 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, under the direction of Principal Investigator Dr. Robert G. Snow, demonstrated that 30% of the patients measured achieved greater than 30% excess weight loss in the 4-6 week period after surgery. Even though they had a band adjustment during surgery, no patient required their band to be loosened in the post-operative period.

About Smart Medical

SMART Medical is a pioneer in the development and manufacture of innovative medical devices in the field of gastro-intestinal (GI) endoscopy. Its NaviAid™ family of products provides a standard endoscope with the means to overcome major challenges in GI endoscopy, through a series of single-use balloon devices and delivery systems. Its commercial products are marketed by a global network of sales agents and distributors. SMART is ISO 13485 certified, and its various products have been cleared by the FDA (in the USA) and have gained the CE Mark (in Europe). In addition to developing its own unique products, SMART collaborates with other prominent companies in the GI endoscopy field to launch successful joint projects.


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