Israeli medical device company Medigus Ltd. has gained U.S. FDA 510(k) clearance for its 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.
Background
Turns out we’ve encountered Medigus before, almost two years ago now when it gained FDA’s nod for its SRS system as we wrote here. Medigus develops minimally invasive endosurgical tools and procedures. Its newly cleared Muse system currently targets patients with symptomatic chronic gastroesophageal reflux disease (GERD). The 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.
Medigus describes its system as 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.
Compared with its predecessor, 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. Medigus says its integral surgical endoscope remains disposable, ensuring patient safety.
Company comments
“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.”
Physician comments
“There are growing concerns about the long-term use of acid suppressing therapy in the treatment of gastroesophageal reflux disease (GERD). I am excited that the Muse system is an endoscopically placed, non-surgical treatment that will provide an alternative therapeutic strategy for GERD patients,” said 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 device, 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.
Source: Medigus, Ltd., Globe Newswire
published: March 26, 2014 in: Approval/Clearance, Gastroenterology, Oncology