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Intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of Gastroesophageal Reflux Disease (GERD).

The Stretta® Catheter is a single use monopolar electrosurgical device. The catheter connects to the Mederi RF Generator by means of a custom electrical connection. The catheter consists of a flexible shaft with a multi-arm basket at the distal end and a control handle at the proximal end. The catheter is introduced trans-orally. The catheter has depth of insertion indicators on the shaft to assist the user in inserting the device to the proper location. Inside the basket is a balloon that when inflated with sterile water or air to expands the basket during use. The basket arms support electrode needles which contact and penetrate esophageal tissue when the basket is expanded and the electrode needles are advanced. The basket arms also contain thermocouples to return temperature measurements to the generator during activation. The balloon is inflated by means of a syringe with an inline pressure relief valve. The procedure, delivery of energy, occurs in several steps where the catheter is positioned, activated, rotated and repositioned during the course of the treatment.

The Mederi Therapeutics RF Generator is intended for general use in the electrosurgical coagulation of tissue, specifically: - The Mederi RF Generator when used with the Secca Disposable Handpiece is intended for the treatment of bowel incontinence in patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy. - The Mederi RF Generator when used with the Stretta Disposable Catheter is intended for the treatment of gastroesophageal reflux disease (GERD).

The Mederi Therapeutics RF Generator Control Module is a Radio Frequency Generator which is used with the Stretta and Secca disposable hand pieces and accessories including irrigation tubing and foot pedal. The Mederi Therapeutics RF Generator Control Module is part of a therapeutic platform for treatment of various medical conditions with radiofrequency (RF) energy. Specifically. for the treatment of two conditions: - Gastroesophageal reflux disease (GERD). Mederi's devices used for treatment of this condition include the Mederi RF generator and the "Stretta" disposable kit. - Fecal Incontinence (FI). Mederi's devices used for treatment of this condition include the Mederi generator and the "Secca" disposable kit. The Mederi RF Generator Control Module is a multi-channel electrosurgical generator that produces low power, radiofrequency (RF) energy using a sinusoidal waveform of 460 kHz. Needle tip and surface tissue temperatures are measured through disposable hand pieces during treatment by thermocouples located at the tip and base of the needle, respectively. The electrode tip temperature measurement regulates the output power in a closed-loop fashion to maintain the target temperature, while monitoring of the surface tissue temperature prevents overheating.