Israel’s Medigus Gets FDA 510(k) Nod for MUSE Fundoplication System
Medigus is in the early stages of rolling out its next-generation Muse System, which allows physicians to perform a less-invasive transoral fundoplication in patients with gastroesophageal reflux disease, following the receipt of FDA 510(k) clearance.
The rollout includes a commercial, clinical and physician training program at selected centers of excellence in the U.S., spokesman Yoav Silberman told Device Daily Bulletin. The system also has a CE mark.
The system consists of two main components: a flexible stapler containing titanium staples, an ultrasonic sight and video capability, and a control box that receives information from the device’s sensors and displays it on a monitor. Muse’s video camera is one of the smallest in the world, the Omer, Israel, devicemaker says, allowing higher digital resolution and a better field of view. The stapler ejection is motorized and controlled by software for safer operation, and the endoscope is disposable to maximize patient safety.
Physicians insert the device through the mouth into the stomach and retroflex, where it clamps the tissue. This is done three times, creating a 180-degree flap valve.
Unlike conventional fundoplication procedures, Muse can be used by a single endoscopist without the need for any kind of incision or scarring, Medigus says. This leads to shorter post-procedure hospital stays and recovery time.
Muse met its primary safety and efficacy endpoints in a multicenter trial completed in 2011. A 2007 pilot study showed that Muse produced results similar to those attained in laparoscopic fundoplication surgeries. — Lena Freund
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