The system enables the operator to staple the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. Other risk factors affecting the company are discussed in detail in the Company's filings with the Securities and Exchange Commission. Recent research conducted using the MUSE system by Medigus has shown promise for long-term reduction or elimination of GERD symptoms in patients with moderate to severe GERD. Anti-retching medications at the time of the procedure are essential. It has the advantage of enhanced safety resulting from ultrasound guidance; when direct visualization isn't possible, an ultrasonic range finder automatically engages to measure tissue thickness. Stretta delivers thermal energy to multiple sites in the lower esophageal sphincter and gastric cardia, producing a tissue-tightening effect related to heat-induced fibrosis. GERD patients who undergo the Stretta procedure can expect to see a reduction of their GERD symptoms for up to 10 years, according to researchers. I am honored to be one of the first and most experienced gastroenterologists using MUSE to help patients with GERD. The primary safety assessment time point will be within 30 days of the procedure. However, this is still a fairly new procedure, so long-term results are unknown. Medications do not correct the underlying processes, which is the malfunction of the gastroesophageal valve (the valve between the esophagus and stomach) caused by wear and tear. Medications, by decreasing the amount of acid, can help with some symptoms. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Medigus' MUSE™ innovative endoscopy system for the treatment of GERD performs an anterior fundoplication in lieu of the current sugical procedure, but without opening the abdominal cavity. The physicians staples the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. Sign in|Recent Site Activity|Report Abuse|Print Page|Powered By Google Sites. Each application of the device fires a quintuplet of staples (5) in three staggered rows. Also, reinforcement of the gastroesophageal valve through MUSE, could potentially delay worsening of GERD and delay or stop further weakening of the gastroesophageal valve and progression of the disease. Medigus is traded on the Nasdaq Capital Market and the TASE (Tel-Aviv Stock Exchange). The device addresses “the root cause” of GERD rather than just relieving symptoms. In addition to writing for HealthCentral, she does patient consults and serves on the Board of Directors for the Pediatric Adolescent Gastroesophageal Reflux Association. "Within six months and up to three years, both procedures seem to be associated with a significant improvement in GERD-related quality of life and perception of acid reflux. Epub 2014 Aug 19. In this three year follow-up with patients who had the MUSE procedure over traditional fundoplication, the long-term success was also seen. Gastroesophageal reflux disease (GERD) is the most common reason U.S. adults see a gastroenterologist and the leading indication for upper endoscopy. This is great news for GERD sufferers who are looking for a minimally invasive procedure with long-term positive outcomes. The TIF procedure clinical objectives are a) to mechanically repair a defective gastroesophageal valve and b) to reduce small hiatal hernias. 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 registry evaluates the MUSE System which creates a transoral anterior fundoplication for the treatment of GERD. Further, GERD health-related quality of life (GERD-HRQL) improved by greater than 50 percent in nearly three-quarters of patients six months after the procedure. In a single center cohort study, Dughera et al. Surg Endosc. The MUSE system is a single-use flexible transoral stapler that merges the latest advancements in microvisual, ultrasonic and surgical stapling. However, this is still a fairly new procedure, so long-term results are unknown. 2015 Dec;29(12):3717-21. doi: 10.1007/s00464-015-4142-9. The staples are standard, 4.8mm titanium surgical staples. Patients after MUSE generally can stop their medications completely or take it only on an as-needed basis. A single copy of these materials may be reprinted for noncommercial personal use only. See how we're providing safe in-person care and virtual visits, Review the latest COVID-19 resources and research advancements, Mayo Clinic College of Medicine and Science, Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. They are titrated off PPIs over a period of weeks and if they continue to do well, discontinue medication completely. “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. By their nature, Forward-Looking Statements involve known and unknown risks, uncertainties and other factors which may cause future results of the company's activity to differ significantly from the content and implications of such statements. 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