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FDA clears Mederi's new generator for Stretta and Secca systems

 
• By Madeleine Armstrong

The US FDA has granted 510(k) clearance for Mederi Therapeutics’ MDRF1 generator, which is used to power the firm’s Stretta and Secca systems. The former device is used to treat gastroesophageal reflux disease (GERD), while the latter treats bowel incontinence or bowel control disorder. Both devices use radiofrequency energy to remodel the valves or sphincters at either end of the digestive tract. The new generator is smaller, lighter and has a more intuitive user interface than its predecessors, Greenwich, Connecticut-based Mederi claims. Previously, the two devices were powered by two separate generators, so combining them into one could reduce costs, the company added. Mederi CE marked its next-generation Stretta and Secca systems in November (www.clinica.co.uk, 9 November 2010).

The US FDA has granted 510(k) clearance for Mederi Therapeutics’ MDRF1 generator, which is used to power the firm’s Stretta and Secca systems. The former device is used to treat gastroesophageal reflux disease (GERD), while the latter treats bowel incontinence or bowel control disorder. Both devices use radiofrequency energy to remodel the valves or sphincters at either end of the digestive tract. The new generator is smaller, lighter and has a more intuitive user interface than its predecessors, Greenwich, Connecticut-based Mederi claims. Previously, the two devices were powered by two separate generators, so combining them into one could reduce costs, the company added. Mederi CE marked its next-generation Stretta and Secca systems in November (www.clinica.co.uk, 9 November 2010).

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