EnteroMedics Announces First-Of-Its-Kind Procedure With vBloc Therapy Used As Adjunctive Rescue Treatment For Failed Gastric Sleeve In Patients With Obesity
ST. PAUL, Minn., June 1, 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 a first-of-its-kind procedure in which the Company's vBloc® Neurometabolic Therapy was used as an adjunctive rescue treatment in two patients with obesity who failed to achieve sufficient weight loss and diabetes control with their previous gastric sleeve surgeries.
Both vBloc procedures were recently performed at the VA North Texas Health Care System by Sachin Kukreja, M.D., Director of Bariatric Surgery. The patients included two veterans, a 64-year-old male and a 55-year-old female, both with a Body Mass Index (BMI) of between 35 and 40, and both suffering from diabetes. Each had lost and maintained significant weight loss with their sleeve gastrectomies, but remained with class 2 obesity and diabetes. Each were offered the option to proceed to duodenal switch, gastric bypass, or vBloc, and both opted for vBloc. Their surgeries were performed without incident, and the patients are both recovering well.
"Patients with obesity who have co-morbid diabetes need to understand the urgent need to achieve weight loss to improve their health," said Dr. Kukreja. "For some patients, despite having bariatric surgery like a gastric sleeve, additional measures may be necessary to overcome the many signals driving their obesity. vBloc therapy helps to target the neurologic drive that may provide a barrier to optimum weight loss. As the first VA facility to perform a vBloc procedure in 2015, we have witnessed first-hand the unique and innovative approach that vBloc provides to patients struggling with obesity. vBloc therapy is highly adaptable and can be individualized for each patient to control hunger and provide a feeling of fullness when they most need it. This results in safe, durable weight loss while helping to control co-morbidities. vBloc is also minimally invasive and now, as an adjunctive rescue therapy, will provide an attractive treatment option for patients fighting their obesity after undergoing more invasive surgical treatments."
"This first-of-its-kind procedure provides critical insight into patient decision-making in individuals who have already opted to undergo, yet failed, an anatomy-altering or lifestyle-restricting bariatric procedure," said Scott Shikora, M.D., F.A.C.S., EnteroMedics Executive Vice President and Chief Medical Officer. "Many patients want a solution to their obesity that does not involve the sacrifices associated with more invasive procedures. Because vBloc therapy offers this, it holds the potential to drive greater adoption of bariatric weight loss procedures, improving patient health and reducing the costs associated with treating obesity and its co-morbidities."
Dan Gladney, EnteroMedics President and Chief Executive Officer, added: "There are over 100,000 gastrectomies performed in the United States each year. Up to one-third of these patients will not achieve or maintain meaningful weight loss after five years. The VA is a pioneer in bariatric surgeries, offering veterans an important means of addressing their obesity and its co-morbidities. Our experiences at the VA and other centers across the U.S. will provide an important foundation for our continued commercial progress and expanded use of vBloc Therapy. Obesity is a chronic disease that often requires chronic treatment; vBloc used as an adjunctive therapy may play an important role for many."
vBloc therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a Body Mass Index (BMI) of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as Type 2 diabetes, high blood pressure or high cholesterol levels.
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 Neurometabolic 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 28, 2016. 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.
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SOURCE EnteroMedics Inc.
