Healthcare Industry News: obstructive sleep apnea
News Release - May 18, 2017
EnteroMedics Announces First vBloc(R) Neurometabolic Therapy Implant at McGuire Veterans Affairs Medical CenterST. PAUL, Minn., May 18, 2017 -- (Healthcare Sales & Marketing Network) -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the McGuire Veterans Affairs Medical Center (Richmond VAMC) in Richmond, VA successfully completed its first implant of the Company's vBloc® Neurometabolic Therapy. The surgery was performed earlier this week by James Maher, MD.
"Obesity and its comorbidities must be addressed in order to live a healthier and fuller life," said Dr. Maher. "Providing the best medical options to combat morbid obesity to the men and women who have served our country is a top priority and with vBloc Therapy available at the Richmond VAMC, we are now able to provide a safe and effective alternative to invasive, anatomy-altering and restricting procedures. There are well over one million veterans with obesity and the Richmond VAMC is committed to helping those in our communities succeed in their fight against obesity."
The vBloc System works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally-invasive procedure that does not alter or remove any patient anatomy. The device can be adjusted to optimize patients' therapy needs and works to give the patient a sensation of fullness, empowering them to eat less, control their appetite, and lose weight. Studies have shown that vBloc Therapy produces meaningful weight loss in patients as well as meaningful improvements in related comorbidity factors, such as HbA1c, without the major lifestyle implications of traditional weight loss surgeries.
"One in ten Virginians is a veteran and the State has the fastest growing veterans' population in the Nation," said Dan Gladney, EnteroMedics President, Chief Executive Officer and Chairman of the Board. "With our first implant at the Richmond VAMC, we are making vBloc accessible to an even larger portion of the men and women who have served our country selflessly and are in need of solutions to address their obesity. Through our previously announced partnership with Academy Medical, eligible veterans are able to receive vBloc Therapy at little to no cost. We look forward to working with other VA medical centers and VA Choice facilities so they can offer this state-of-the art weight loss treatment."
vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a 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, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years.
About McGuire Veterans Affairs Medical Center
The McGuire Veterans Affairs Medical Center is home to the latest and most sophisticated medical equipment and facilities for health care delivery for our Nation's Heroes. Last year, the medical center served nearly 60,000 veterans and active duty service members with more than 700,000 visits. Over 80% of the medical center's research has a direct impact on patient care studies in the VA system and in the community. The medical center also provides outpatient services through the Fredericksburg, Emporia, and Charlottesville VA Community Based Outpatient Clinics.
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 vBloc® System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics' vBloc® System has received U.S. Food and Drug Administration approval and CE Mark.
Information about the vBloc® System and vBloc® Neurometabolic Therapy
You should not have an implanted vBloc® 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 vBloc 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 vBloc 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 within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," other words of similar meaning and the use of future dates. Forward-looking statements in this release include the possibility of a larger number of veterans accessing the vBloc® System and the Company's desire to work with other VA medical centers and VA Choice facilities. These forward-looking statements are based on the current expectations of our management and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others: our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience with our vBloc® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; the competitive industry in which we operate; our ability to maintain compliance with the Nasdaq continued listing requirements; our ability to commercialize our vBloc® System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our vBloc® System; physician adoption of our vBloc® 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; the cost and management time of operating a public company; 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 8, 2017 and quarterly report on Form 10-Q filed May 15, 2017. 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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