Mederi Therapeutics Inc. announced today that it has received FDA 510(k) clearance for its new MDRF1 Generator.
The Mederi RF Generator powers the Stretta® System for treatment of Gastroesophageal Reflux Disease (GERD) as well as the Secca® System for Bowel Incontinence or Bowel Control Disorder (BCD).
"Today's FDA clearance of the MDRF1 is the culmination of significant investment and design efforts by Mederi. The goal of the MDRF1 project was to produce a system of the highest quality and reliability to treat these two serious and debilitating conditions," stated Will Rutan, Mederi's CEO. "Mederi's new RF generator dramatically reduces the user's capital spending requirements by combining two power generators into one. The MDRF1 is a smaller, lighter and highly portable radiofrequency generator with a more intuitive user interface than its predecessors," continued Rutan. "The MDRF1 combines the functionality of these earlier models into one system that powers both the Stretta and Secca devices."
The availability of these products represents a significant advancement in minimally invasive options for the millions of people who suffer from GERD or BCD. The treatments involve delivery of radiofrequency energy to the sphincter muscles at either end of the digestive system. Both Secca and Stretta bridge the gap between conservative or pharmacologic therapy and invasive surgery – giving doctors and patients an effective and less complicated alternative.
This FDA 510(k) clearance, as well as our recently awarded CE Mark, and ISO 13485 certification, demonstrate Mederi's steadfast commitment to innovation, safety and quality.
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