March 25, 2015
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First MUSE procedures for GERD performed in Italy

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The first Medigus Ultrasonic Surgical Endostapler, or MUSE procedures, for the treatment of gastroesophageal reflux disease were recently performed, the manufacturer announced.

Three of these new incisionless procedures were performed in February by Pier Alberto Testoni, MD, director of gastroenterology and digestive endoscopy IRCCS at San Raffaele Hospital in Milan, Italy, according to the release. After the procedures, all three patients were released from the hospital in 2 days with no complications and have since reported improvement in reflux symptoms, reduced or eliminated anti-reflux drug use and no pain or discomfort after treatment.

“MUSE offers several benefits over the leading laparoscopic method for the long-term treatment of GERD,” Testoni said in the release. “I was able to complete a single procedure in about 1 hour, since the device is fully integrated with all capabilities and the treatment can be administered by a single physician. Because it requires no incisions, the patients reported greater comfort during treatment, their hospital stays were reduced by 50% through treatment with MUSE over more invasive fundoplication procedures, and they were able to return to most of their daily activities after about a week. In follow-up visits, all three patients have reported feeling significant relief from their GERD symptoms.”

The MUSE device is the result of integrating breakthrough visualization, ultrasound and surgical stapling into one platform, enabling one operator to perform fundoplication, the release said. The device addresses “the root cause” of GERD rather than just relieving symptoms.

“We are proud to partner with a leading name in the field of gastroenterology, such as Professor Testoni, to offer a less-invasive and more cost-effective option to patients, physicians and the health care system in Italy, where GERD is prevalent,” Chris Rowland, CEO of Medigus, said in the release. “As a single, comprehensive endoscopic device, MUSE uniquely addresses the existing gap in GERD treatment between drug therapy and invasive laparoscopic procedures.”

MUSE is FDA-approved and CE-marked for GERD, and is being introduced in European and US markets currently, the release said. Distribution plans for Asia in the next few years are in development.