Data Demonstrates Consistent Improvement in GERD Symptoms
OMER, Israel, October 15, 2013
Medigus Ltd. (MDGS.TA), a leading medical device company dedicated to the development of innovative endoscopic procedures and technologies, announced today the presentation of five-year follow-up data on a pilot study of its FDA-cleared (510K) SRS™ Surgical Stapler for the treatment of GERD at the 2013 United European Gastroenterology’s (UEG) Week in Berlin.
The study demonstrated a five years follow-up of an endoscopic fundoplication procedure using the company’s SRS™ device. The study's subjects continued to report improved quality of life scores, and had either reduced or eliminated proton pump inhibitor (PPI) use. The pilot study had been conducted at the Deenanath Mangeshkar Hospital and Research Center in Pune, India in 2007.
This conclusion is based upon the following data: (a) the success rate in the primary efficacy endpoint (known as GERD-HRQL) among the patients participating in the follow-up was over 90% (all but one patient showed successful results, while the remaining patient's results were borderline successful); and (b) approximately 73% of the participants ceased taking PPI medication for the treatment of GERD following the endoscopic procedure or considerably reduced their medication intake. Eleven of the thirteen patients in the study participated in the follow-up.
“This study suggests that at 5-years follow-up, results of SRS™ fundoplication are similar to laparoscopic fundoplication in terms of PPI use & QOL improvement. The results demonstrate the clinical value of the SRS™ device, as it provides excellent results utilizing a minimally-invasive procedure,” said lead investigator of the study, Dr. Amol Bapaye, who presented the results at UEGW.
The SRS™ endoscopic system consists of a disposable surgical endoscope and surgical stapler with an ultrasonic sight and range finder, which performs an anterior fundoplication in lieu of the current standard surgical procedure. The SRS™ system does so without the need for incisions or opening the abdominal cavity. The system has been cleared for treatment of chronic Gastroesophageal Reflux Disease (GERD), one of the most common chronic diseases. The operation can be performed by a single surgeon or GI in the endoscopy suite to ensure saving of operation room time.
“Our enthusiasm regarding the potential for our SRS™ system continues to be supported by such encouraging follow-up data, such as that presented at the UEG meeting,” said Christopher Rowland, CEO of Medigus, Ltd. “This endoscopic approach is an important addition to the treatment methodology for GERD, and we believe it will set the standard for how the disease is managed.”