Medigus Receives FDA Clearance for Next Generation MUSE™ System
OMER, Israel, March 23, 2014 – Medigus Ltd. (TASE: MDGS), a medical device company developing minimally invasive endosurgical tools and procedures announced today that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the next generation MUSE™ System, formerly known as the SRS™ System. MUSE™ is a device which enables an incisionless procedure by performing an anterior partial fundoplication with standard surgical staples in a less invasive way. The procedure currently targets patients with symptomatic chronic gastroesophageal reflux disease (GERD). The MUSE™ System provides these patients, who are typically at higher risk of developing esophageal cancer, with a potential long-term solution which aims to restore the esophageal anatomy with a minimally invasive tool in order to reduce or eliminate their GERD symptoms.
“FDA clearance of the MUSE™ System is a significant milestone for Medigus and will allow patients in the U.S. to have access to the most advanced technology for treating GERD,” said Chris Rowland, CEO, Medigus. “This is an important achievement in our 2014 strategic plan, and allows us to focus on the implementation of a scalable commercial, clinical and physician training model through the establishment of “centers of excellence” in the U.S. It also positions our company for sustained, significant long-term growth and becoming a leader in the field of minimally invasive endosurgical devices.”
The new MUSE™ System is easier to use, with an improved graphical user interface. The next generation system leverages LED illumination and advancements in one of the world’s smallest video cameras to achieve enhanced, digital resolution and an improved field of view. In addition, the new system has a more compact console, motorized stapler ejection mechanism, software controls ensuring safe operation, and an alignment pin mechanism to ensure precise alignment prior to staple delivery. These new features complement existing elements such as ultrasound guidance and easy handling, enabling single operator surgery. The surgical endoscope remains disposable, ensuring patient safety.
“Recognizing the strong link between GERD and esophageal cancer, one of the fastest growing cancers, I am pleased that the MUSE™ System will now be available to treat patients with this unique minimally invasive solution to enhance patient care and potentially reduce hospital stays and lower costs,” said Dr. David Cave, M.D., Ph.D., Gastroenterologist, UMass Memorial Medical Center.
The MUSE™ System is used to perform minimally invasive treatment of gastroesophageal reflux disease, which is one of the most common chronic diseases in the Western world. In a multicenter clinical trial completed in 2011, success was attained in the primary efficacy and safety endpoints according to the trial protocol. An earlier pilot study conducted in 2007 produced five-year follow-up results which are similar to results received in surgical laparoscopic procedures, considered the gold standard for GERD treatment. These studies were completed with a previous generation of MUSE™, however, they utilized the same surgical staples and stapling patterns as the new MUSE™ System. These results suggest long-term efficacy of the MUSE™ System procedure and its potential to serve as an alternative therapy to invasive surgery for chronic GERD patients.
MUSE™ is an intuitive endosurgical platform that consists of a single use surgical endostapler, equipped with a proprietary miniature camera, an ultrasonic sight and a range finder. The single operator system performs an anterior partial fundoplication with standard surgical staples in a less invasive way, compared to other surgical procedures.
Medigus is leading the transition from invasive gastric surgery procedures to less invasive, patient-friendly techniques through the development of minimally invasive endoscopic devices and procedures. The company's revolutionary MUSE™ System enables endoscopists to treat gastroesophageal reflux disease (GERD), a chronic disease with increasing global prevalence, by performing a fundoplication procedure through the mouth. Unlike current fundoplication procedures, the MUSE™ System does not require abdominal incisions, which may result in shorter post-procedure recovery. The MUSE™ System (previously known as SRS™ System for transoral fundoplication) has received FDA clearance and CE mark. Medigus is traded on the TASE (Tel Aviv Stock Exchange). To learn more about the company's minimally invasive technology platform, please visit http://www.medigus.com/.