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[1], 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.
About 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 more likely to develop esophageal cancer.
About MUSE
The MUSE system is a leading technology in Natural Orifice Endoscopic
Surgery 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. Medigus anticipates that the new Category 1 Current Procedural Terminology (CPT®) code, recently created by The American Medical Association (AMA) for Esophagogastric Fundoplasty Trans-Orifice Approach procedures, would be the code used for MUSE.
About Medigus
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(TM) 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 technology. Based on its proprietary technologies, Medigus designs and manufactures endoscopy and micro camera systems for partner companies, including major players in the medical and industrial fields. 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 www.medigus.com or www.microscoutcam.com.
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This press release contains "Forward-Looking Statements," which are based upon the current estimates, assumptions and expectations of the company's management and its knowledge of the relevant market. Forward-Looking Statements involve uncertainties which may cause future results of the company's activity to differ significantly from the content and implications of such statements. Among the factors which may cause the actual results to differ from the Forward-Looking Statements are changes in the target market and the introduction of competitive products, regulatory, legislative and policy changes, and clinical results. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this press release should be deemed to be medical or other advice of any kind.
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[1] Roy-Shapira, A., Bapaye A., Date, S., Pujari, R., & Dorwat, S. (2015). Trans-oral anterior fundoplication: 5-year follow-up of pilot study.Surgical Endoscopy, online February 19, 2015 doi:# 10.1007/s00464-015-4142-9
http://link.springer.com/article/10.1007%2Fs00464-015-4142-9
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