Medigus Ltd., a medical device company developing minimally-invasive, endosurgical tools and procedures, points us at two presentations at last week’s Digestive Disease® Week annual meeting, involving the use of its MUSE™ System for transoral fundoplication.
Background
Medigus has merged recent breakthroughs in visualization, ultrasound and surgical stapling capabilities into one platform, its so-called MUSE System. The result is safe, incisionless procedures within the GI tract using 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 MUSE procedure is effectively a surgical anterior fundoplication with standard surgical staples, performed in a less invasive way, helping enhance patient care. The procedure can be performed by a single surgeon or endoscopist in the endoscopy suite.
Back in late March we covered the news that the U.S. FDA had cleared Medigus’ Muse system for treatment of Gastro-Esophageal Reflux Disease (GERD).
Now Medigus is pointing us at two presentations at last week’s Digestive Disease® Week (DDW) annual meeting, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, which took place in Chicago IL.
In the first study, William Kessler, M.D., FACG, Associate Professor, IU Health, reported on a three year follow-up of patients treated with the MUSE System. Results showed that it proved safe and effective for patients with Proton Pump Inhibitor (PPI)-responsive, moderate-to-severe GERD. In addition, it showed that the majority of patients (74%) remained off daily PPI at three years post-procedure and those who continued to take PPIs post-procedure reported a decrease in dosage over the three-year period.
In the second study, Rosamaria Bozzi M.D., Unit of Surgery and Surgical Endoscopy, Azienda Ospedaliera dei Colli, Italy, and team tested the feasibility of combining a transoral fundoplication using the MUSE system with submucosal myotomy, as a treatment for achalasia (smooth muscle disorder, in this case of the esophagus). Results showed that it is possible to successfully combine the two procedures to achieve an incisionless treatment, compared to the standard laparoscopic surgery for achalasia.
Investigator comments
“For a growing number of GERD patients who are PPI-dependent, traditional invasive surgery is often considered,” said William Kessler, M.D., FACG, Associate Professor, IU Health. “The results of our longer-term study showed that the incisionless MUSE System is relatively effective in eliminating or decreasing PPI use among most GERD patients via this new minimally-invasive procedure.”
Company comments
“The data presented at DDW 2014 underscore the MUSE System’s safety and ability to provide improved and long-term outcomes for the estimated 2.4 million American adults with severe or refractory GERD,” said Chris Rowland, CEO, Medigus. “These results establish a clear role for the MUSE System in endoluminal GERD therapy as a non-invasive system that enhances patient care and provides long-term results.”
Source: Medigus, Inc., Globe Newswire
published: May 8, 2014 in: Clinical Studies/Trials, Congresses and Meetings, Endoscopy, Gastroenterology