Mederi Therapeutics Inc announced today that it has received a CE Mark authorizing the European distribution and use of Mederi's second generation of the Stretta and Secca Systems. The Stretta System is for treatment of gastric reflux disease, commonly known as GERD, and the Secca System is for treatment of bowel control disorder, or BCD. These latest systems include a streamlined user interface, significant improvements in ease of use, and are smaller, lighter, and highly portable.
"Mederi is very pleased to offer the Stretta system for the treatment GERD and the Secca system for treatment of BCD. Mederi has made a substantial capital investment which has resulted in numerous improvements to these novel technologies," stated Will Rutan, CEO and President of Mederi Therapeutics. "The Secca and Stretta systems are ultra-minimally invasive technologies that bridge a significant gap that exists between conservative therapies and invasive surgical options for GERD and BCD. Numerous clinical studies have shown Stretta and Secca to be effective therapeutic options."
The second generation Stretta and Secca devices were launched at UEGW 2010, the annual congress of the United European Gastroenterology Federation, which was held in Barcelona, Spain, October 23-27. "It was exciting to witness the overwhelming response to Stretta and Secca, resulting in numerous requests to purchase Mederi products at the recent European congress. As the only endoluminal therapies for GERD and BCD, the interest and demand for these novel technologies is extremely high," added Rutan. Concurrent with the EU launch activities, Mederi has engaged and trained a worldwide distribution network to drive demand and ensure safe and proper use of Stretta and Secca.
The CE Mark and ISO 13485 certification demonstrate Mederi's steadfast commitment to safety and quality.