ST. PAUL, Minn., Jan. 5, 2016 /PRNewswire/ -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced the publication of a position statement on vagal blocking therapy for obesity by Pavlos Papasavas, MD, Maher El Chaar, MD and Shanu N. Kothari, MD, on behalf of the American Society for Metabolic and Bariatric Surgery (ASMBS), in the journal Surgery for Obesity and Related Diseases. The position statement was prepared after review by the ASMBS Clinical Issues Committee and is available online here.
Following a review of the mechanism of action and clinical results of vBloc Neurometabolic Therapy, the article noted that, "the quantity of the data available at this time (6 published studies, approximately 600 implanted devices) and the length of follow-up indicate adequate safety and efficacy in the short and medium term." The article concluded that "the society currently supports...vBloc for the treatment of obesity and encourages members to participate in post FDA approval studies," and that "the prospective collection of VBLOC outcomes as part of the national bariatric accreditation program (MBSAQIP) is encouraged in order to establish further efficacy of this new technology."
"vBloc is an innovative and safe alternative to existing therapies, producing weight loss that restores health while directly addressing the underlying challenges of obesity for the individual, including hunger and satiety," said Scott Shikora M.D. F.A.C.S, EnteroMedics Executive Vice President and Chief Medical Officer. "The ASMBS' position statement reflects a strong level of support for vBloc within the bariatric community. We appreciate the continuing support of ASMBS and its members as vBloc is introduced as an important tool in their practices to support patients who wish to lose weight and become healthier."
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics' Maestro Rechargeable System has received U.S. Food and Drug Administration approval, CE Mark and is listed on the Australian Register of Therapeutic Goods.
Information about the Maestro® Rechargeable System and vBloc® Neurometabolic Therapy
You should not have an implanted Maestro Rechargeable System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the Maestro Rechargeable System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.
Talk with your doctor about the full risks and benefits of vBloc Therapy and the Maestro Rechargeable System. For additional prescribing information, please visit www.enteromedics.com.
If you are interested in learning more about vBloc Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial sales experience with our Maestro® Rechargeable System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and vBloc® Neurometabolic Therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission, particularly those factors identified as "risk factors" in the annual report on Form 10-K filed March 13, 2015. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
SOURCE EnteroMedics Inc.