Medigus' Multi-Center Prospective Study Published in Surgical Endoscopy
OMER, Israel, September 8, 2014 – Medigus Ltd. (TASE: MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, announced today the publication of results from a multi-center prospective study, “Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial” in the August online edition of Surgical Endoscopy, the official journal of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and European Association for Endoscopic Surgery (EAES). Study results were announced in 2013 and previously presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Meeting in April 2014.
“The benefit of the MUSE™ System is its ability to actually solve the problem of severe, persistent GERD instead of just camouflaging its symptoms, which many current medical treatments do”, said Johannes Zacherl, MD, Head of the Center for Esophageal and Gastric Surgery, Herz Jesu Hospital in Austria, and lead investigator at the first of six worldwide centers to participate in the study . “It’s a simple procedure that may deliver a real and permanent solution for many patients”.
The procedures were performed under general anesthesia with intubation in either an operating room or a therapeutic endoscopy suite. A transoral stapler was progressed into the stomach through an overtube and retroflexed under direct video guidance. After identifying a stapling location, the stapler was gently pulled back to place the staple cartridge in the esophagus approximately 3cm above the gastroesophageal junction.
Unlike other procedures, the MUSE™ endostapler closely mimics surgical anterior fundoplication through transoral stapling. The device incorporates a video camera for direct visualization during insertion and staple site selection and ultrasound to determine when a proper stapling gap is achieved.
Conducted between May 2008 and November 2010, the study had evaluated 69 patients who underwent endoscopic transoral fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSE™). Six months after the procedure, nearly three-quarters (73%) of the patients reported an improved GERD health-related quality of life (HRQL) score equal to or more than 50%. The study also shows that 85% of patients who underwent the procedure and completed follow up had clinically significant improvements in their use of daily acid reducing medications (proton pump inhibiters or PPIs) as treatment for their GERD: 65% of patients eliminated use of all GERD medications and another 20% of patients reported at least a 50% dose reduction.
“The publication of this study represents an important milestone for Medigus as we advance our strategy for expanding use of the minimally-invasive MUSE™ System by key opinion leaders globally to become a leader in the Natural Orifice Surgery (NOS) segment,” said Chris Rowland, CEO of Medigus. “We are proud that Surgical Endoscopy decided to publish the results of the MUSE™ study as it provides important validation for our approach to demonstrating that the MUSE system could be an effective long-term solution for patients with GERD.”