Mederi Therapeutics has obtained FDA 510(k) clearance for its new MDRF1 Radiofrequency 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).
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.
Mederi CEO Will Rutan said FDA clearance of the MDRF1 is the culmination of 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.
"Mederi’s new RF generator 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," Rutan said.
"The MDRF1 combines the functionality of these earlier models into one system that powers both the Stretta and Secca devices."