OMER, Israel, Sept. 8, 2014 (GLOBE NEWSWIRE) -- 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(TM)) 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 on 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 studyi. "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."
Gastroesophageal reflux disease (GERD) occurs when the lower esophageal sphincter spontaneously opens or does not properly close after use, thereby allowing for stomach contents to rise into the esophagus, causing heartburn, irritation and potentially other discomforts. It affects approximately 24M Americans each year; 14.5M adults experience GERD symptoms at least twice a week, and 2.4M adults experience severe symptoms. While some patients can attain symptom relief through the use of proton pump inhibiters, or PPIs, (acid reducing medications), there is, however, growing concern around the prolonged chronic use of PPIs, including increased risk of bone fracture, infectious complications, and interference with anti-platelet medication and the adsorption of essential vitamins and minerals. A persistent state of untreatable GERD could potentially lead to Barrett's Esophagus, a precancerous state which can lead to esophageal cancer. Patients who suffer from daily GERD are seven times more likely to develop esophageal cancer.
Medigus is a medical device company specializing in developing minimally invasive endosurgical tools and highly innovative imaging solutions. Medigus is a pioneer developer of a unique proprietary endoscopic device, the MUSE system, to treat gastroesophageal reflux disease (GERD), one of the most common chronic diseases in the western world. As an expert in micro-endoscopic devices, Medigus has developed a range of micro CMOS (complementary metal-oxide semiconductor) and CCD (charge-coupled device) video cameras, including micro ScoutCam(TM) 1.2, which to the best of the company's knowledge, is the smallest in the world. These innovative cameras are suitable for both medical and industrial applications. The MUSE system incorporates Medigus' revolutionary micro ScoutCam(TM) technology. Based on its proprietary technologies, Medigus designs and manufactures endoscopy and micro camera systems for partner companies, including major players in the medical device and industrial industries. The company is committed to providing integrated solutions to meet all of its customer's imaging needs. Medigus is traded on the TASE (Tel Aviv Stock Exchange). To learn more about the company's advanced technology, please visit http://www.medigus.com/ or www.microscoutcam.com.
The MUSE system is a leading technology in Natural Orifice Transoral Endoscopic Surgery (NOTES) procedures. The single operator system performs anterior partial fundoplication with standard surgical staples in a less invasive way, compared to other surgical procedures. Its intuitive endosurgical platform consists of a single use flexible surgical endostapler, equipped with a proprietary miniature camera, an ultrasonic sight and a range finder. The endostapler, which resembles an endoscope, is designed to be operated by a single user, includes a handle with controls, an 80cm flexible shaft, a 5cm rigid section holding a cartridge with 5 standard 4.8mm titanium surgical staples, a ratchet controlled one-way articulating section, and a distal tip. The MUSE system is FDA cleared and CE marked.
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Chantal Beaudry/ Carrie Yamond
Lazar Partners Ltd.
Hayden/ MS-IR LLC
i Zacherl, Johannes, et al (2014), Surgical Endoscopy, online August 19, 2014 doi:# 10.1007/s00464014-3731-3
Press release (PDF) http://hugin.info/157792/R/1854260/648439.pdf