Incisionless procedure that is gaining worldwide adoption is now available
at top-rated U.S. hospital in Baltimore
OMER, Israel, April 27, 2015 (GLOBE NEWSWIRE) -- Medigus Ltd. (TASE:MDGS), a medical device company developing minimally invasive endosurgical tools and a leader in direct visualization technology, announced today that Dr. Mouen Khashab, Associate Professor of Medicine and Director of Therapeutic Endoscopy at The Johns Hopkins Hospital, an integrated global health enterprise and one of the leading health care systems in the United States, recently completed the first Medigus Ultrasonic Surgical Endostapler (MUSE) procedure at their facility. The MUSE system is used for an incisionless procedure for the treatment of gastroesophageal reflux disease (GERD) and is leading the transition to more patient-friendly procedures for the long-term treatment of this prevalent disorder.
Johns Hopkins has long been committed to innovative technologies to both enhance patient care and challenge convention of traditional medicine to deliver more effective treatments for widespread disorders, such as GERD. MUSE offers a unique new option for the millions of Americans who suffer from persistent GERD symptoms and who currently don't have suitable therapies available to them. With the MUSE procedure, Dr. Khashab was able to reinforce the failing lower esophageal sphincter, thereby repairing the cause of the disorder without incisions. No incisions likely means greater comfort for patients, shorter hospital stays and reduced post-procedure medications.
The prevalence of GERD has been on the rise worldwide and can be linked to esophageal cancer, one of the fastest growing cancers globally. Some GERD patients can develop changes in the lining of their esophagus leading to a condition known as Barrett's esophagus. Most cases of esophageal cancer result from this condition.1 For GERD patients, MUSE offers a potential long-term solution by restoring their esophageal anatomy with a minimally invasive tool to reduce or eliminate their symptoms.
"We are proud that the renowned Johns Hopkins Hospital, along with Dr. Khashab, have adopted the MUSE procedure to help enhance GERD patient care in the U.S.", said Chris Rowland, CEO of Medigus. "About 20% of Americans suffer from severe GERD symptoms each year, many of whom fall within a growing treatment gap between drug therapy and invasive surgical procedures. MUSE offers a novel solution by addressing the root cause of GERD to deliver a long-term relief without the need for incisions. Therefore, we expect the use of MUSE will continue to grow in both the U.S. and abroad."
Medigus has merged recent breakthroughs in visualization, ultrasound and surgical stapling capabilities into a single platform with MUSE. The device is fully integrated with leading microvisual, ultrasonic and stapling technology, and therefore allows a single physician or surgeon to perform fundoplication (connecting the upper part of the stomach, or fundus, to the lower esophageal sphincter). MUSE has the potential to improve GERD-related quality of life for many patients by addressing the root cause of the disorder, not just offer symptom relief, which is often in contrast to many drug therapies.
Gastroesophageal reflux disease (GERD) occurs when the lower esophageal sphincter spontaneously opens or does not properly close after use, thereby allowing for stomach contents to rise into the esophagus, causing heartburn, irritation and potentially other discomforts. It affects approximately 24M Americans each year; 14.5M adults experience GERD symptoms at least twice a week, and 2.4M adults experience severe symptoms. While some patients can attain symptom relief through the use of proton pump inhibiters, or PPIs, (acid reducing medications), there is, however, growing concern around the prolonged chronic use of PPIs, including increased risk of bone fracture, infectious complications, and interference with anti-platelet medication and the adsorption of essential vitamins and minerals. A persistent state of untreatable GERD could potentially lead to Barrett's esophagus, a precancerous state which can lead to esophageal cancer. Patients who suffer from daily GERD are more likely to develop esophageal cancer.
The MUSE system is a leading technology in Natural Orifice Endoscopic Surgery procedures. The single operator system performs anterior partial fundoplication with standard surgical staples in a less invasive way, compared to other surgical procedures. Its intuitive endosurgical platform consists of a single use flexible surgical endostapler, equipped with a proprietary miniature camera, an ultrasonic sight and a range finder. The endostapler, which resembles an endoscope, is designed to be operated by a single user, includes a handle with controls, an 80cm flexible shaft, a 5cm rigid section holding a cartridge with 5 standard 4.8mm titanium surgical staples, a ratchet controlled one-way articulating section, and a distal tip. The MUSE system is FDA cleared and CE marked. Medigus anticipates that the new Category 1 Current Procedural Terminology (CPT®) code, recently created by The American Medical Association (AMA) for Esophagogastric Fundoplasty Trans-Orifice Approach procedures, would be the code used for MUSE.
Medigus is a medical device company specializing in developing minimally invasive endosurgical tools and highly innovative imaging solutions. Medigus is a pioneer developer of a unique proprietary endoscopic device, the MUSE(TM) system, to treat gastroesophageal reflux disease (GERD), one of the most common chronic diseases in the western world. As an expert in micro-endoscopic devices, Medigus has developed a range of micro CMOS (complementary metal-oxide semiconductor) and CCD (charge-coupled device) video cameras, including micro ScoutCam(TM) 1.2, which to the best of the company's knowledge, is the smallest in the world. These innovative cameras are suitable for both medical and industrial applications. The MUSE system incorporates Medigus' revolutionary micro ScoutCam technology. Based on its proprietary technologies, Medigus designs and manufactures endoscopy and micro camera systems for partner companies, including major players in the medical and industrial fields. The company is committed to providing integrated solutions to meet all of its customer's imaging needs. Medigus is traded on the TASE (Tel-Aviv Stock Exchange). To learn more about the company's advanced technology, please visit www.medigus.com or www.microscoutcam.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions and expectations of the company's management and its knowledge of the relevant market. The company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words. By their nature, Forward-Looking Statements involve uncertainties which may cause future results of the company's activity to differ significantly from the content and implications of such statements. Among the factors which may cause the actual results to differ from the Forward-Looking Statements are changes in the target market and the introduction of competitive products, regulatory, legislative and policy changes, and clinical results. Forward-Looking Statements are pertinent only as of the date on which they are made, and the company undertakes no obligation to update or revise any Forward-Looking Statements, whether as a result of new information, future developments or otherwise. Neither the company nor its shareholders, officers and employees, shall be liable for any action and the results of any action taken by any person based on the information contained herein, including without limitation the purchase or sale of company securities. Nothing in this press release should be deemed to be medical or other advice of any kind.
Hayden/ MS-IR LLC
1 ASGE American Society for Gastrointestinal Endoscopy. (n.d). ASGE: Understanding GERD, Barrett's. Retrieved March 31, 2014 from http://www.asge.org/patients/patients.aspx?id=402
Press release (PDF) http://hugin.info/157792/R/1914962/684390.pdf