Treatment with MUSE™ system keeps patients off daily PPI therapy, three-year follow up study results
Medigus Ltd., a medical device company developing minimally-invasive, endosurgical tools and procedures, announced recently that two presentations involving the use of its MUSE™ System (formerly the SRS™ System) were presented at the prominent 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.
Medigus has merged recent breakthroughs in visualization, ultrasound and surgical stapling capabilities into one platform, the MUSE™ System, to enable safe, incisionless procedures within the GI tract. The MUSE™ procedure is intuitive and can be performed by a single surgeon or endoscopist in the endoscopy suite. The device performs a surgical anterior fundoplication with standard surgical staples in a less invasive way, helping enhance patient care.
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 the MUSE™ System proved safe and effective for patients with 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.
"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."
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 myothomy, as a treatment for achalasia. 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.
"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."