Medigus' 5-Year Follow Up of Pilot Study Published in Surgical Endoscopy
OMER, Israel, April 14, 2015 (GLOBE NEWSWIRE) -- Medigus Ltd. (TASE: MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, announced the publication of a peer reviewed journal article of a study on the Medigus Ultrasonic Surgical Endostapler (MUSE(TM)), "Trans-oral anterior fundoplication: 5-year follow-up of pilot study" in the 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).
According to the authors of the study, the results demonstrate a durable positive impact on the patients treated with MUSE in terms of reduction- or elimination- of GERD medication use and improvement in GERD-HRQL (Health Related Quality of Life) over the long-term. The research indicates that fundoplication performed with MUSE has the potential to effectively relieve GERD similar to results from more invasive, laparoscopic procedures.
The study evaluated 13 GERD patients who had incomplete response to high dose proton pump inhibitors (PPI) - the most effective class of GERD medications. The patients underwent trans-oral anterior partial fundoplication for the treatment of GERD with the MUSE system. At six weeks, it was reported that 92% of patients had stopped GERD medications daily and had normalized quality of life scores, 69% had eliminated use of GERD medications altogether and average esophageal acid content was significantly reduced following the procedure. Based on these outcomes, the study authors concluded that the procedure was an effective treatment choice for GERD and initiated a larger, multicenter study. Meanwhile, the researchers continued to interview these 13 patients annually. After 5 years, over 90% of study participants maintained their normalized quality of life measures and approximately 77% had ceased taking daily GERD medications.
The procedure performed with the MUSE system is incisionless and leverages recent technological advancements in microvisualization, ultrasound and surgical stapling, to deliver an innovative solution for those who suffer from GERD. With MUSE, a single physician or surgeon is able to provide the treatment, and because no incisions are required, it has the potential to offer enhanced patient comfort, reduced hospital stays and post-procedure recovery times over more invasive, laparoscopic procedures.
"We are pleased that Surgical Endoscopy has recognized and published these study results, as it further supports MUSE's potential to be a leading endoscopic solution for the long-term treatment of GERD. The completion of this IRB-approved study and publication of its results is another achievement for Medigus, as the use of MUSE continues to grow in countries around the world," said Chris Rowland, CEO of Medigus.
The publication of this pilot study is the first long-term follow-up available for the MUSE system. This pilot study was a precursor to a much larger pivotal study, which was recently published. "Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE(TM)) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial," was published in the January 2015 issue of Surgical Endoscopy.
Surgical Endoscopy article