Healthcare Industry News: vBloc
News Release - May 31, 2017
EnteroMedics Announces First vBloc(R) Neurometabolic Therapy Implant at AMITA Health Adventist Medical Center BolingbrookST. PAUL, Minn. and ARLINGTON HEIGHTS, Ill., May 31, 2017 -- (Healthcare Sales & Marketing Network) -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices to treat obesity, metabolic diseases and other gastrointestinal disorders, and AMITA Health, a health system focused on delivering the most efficient, highest quality, faith-based care, today announced that AMITA Health Adventist Medical Center Bolingbrook in Bolingbrook, Illinois successfully completed its first implant of the Company's vBloc® Neurometabolic Therapy. The procedure was performed approximately three months ago by Vafa Shayani, M.D., a bariatric surgeon at the AMITA Health Bariatric & Weight Loss Center, and the patient already has lost about 30 pounds.
"vBloc Therapy is an anatomy-preserving and minimally invasive option where we do not cut or alter any part of the stomach or digestive tract," said Dr. Shayani. "For many patients, there are few effective options outside of drastic anatomy-altering surgeries to help them successfully manage their weight and commonly associated conditions such as diabetes, high blood pressure and high cholesterol. AMITA Health is excited to now offer this revolutionary weight-loss procedure to our patients."
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 hemoglobin A1c (HbA1c), without the major lifestyle implications of traditional weight-loss surgeries.
"With the obesity rate over 30 percent in the state of Illinois, we are proud to work with AMITA Health to make vBloc accessible for those struggling with weight loss, and we are pleased to learn Dr. Shayani's patient achieved excess weight loss of about 32 percent and total body weight loss of 9 percent after approximately three months," said Dan Gladney, EnteroMedics President, Chief Executive Officer and Chairman of the Board. "As we begin to see more commercial vBloc procedures performed, we continue to build on the existing body of evidence demonstrating that vBloc is a safe and effective weight-loss option for obese patients."
"Since starting vBloc Therapy, I've lost close to 30 pounds and feel great," said Mark Kaschube, a dentist and patient of Dr. Shayani who received vBloc Therapy nearly three months ago. "I struggled for three-to-four years to control feelings of constant hunger, and I had no success. I used to be a very active person, but because of my weight, I had to give up things such as skiing with my wife and kids. I'm looking forward to losing additional weight so I can return to my active lifestyle."
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 AMITA Health Bariatric & Weight Loss Center
The AMITA Health Bariatric & Weight Loss Center provides personalized solutions to promote sustained weight loss. The center is a leader in a variety of minimally invasive surgical solutions supported by the American Society for Metabolic & Bariatric Surgery. The center has three bariatric surgery facilities accredited by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program: AMITA Health Adventist Medical Center Bolingbrook, AMITA Health Alexian Brothers Medical Center Elk Grove Village and AMITA Health St. Alexius Medical Center Hoffman Estates. The center's bariatric surgeons collectively have performed more than 10,000 procedures, and the center has the highest bariatric surgical volume in Illinois. The center also offers comprehensive medical weight-loss solutions, with a supportive team of medical providers, dietitians, exercise specialists, social workers and behavioral counselors who work together to provide evidence-based weight-management care for patients. For more information about the center and its medical and surgical options for long-term weight management, visit www.AMITAhealth.org/weightloss or call 855.839.2589.
About AMITA Health
AMITA Health (www.AMITAhealth.org) is a joint operating company formed by Adventist Midwest Health, part of the Adventist Health System in Altamonte Springs, Florida, and Alexian Brothers Health System, a subsidiary of St. Louis-based Ascension. Headquartered in Arlington Heights, Illinois, AMITA Health is the third-largest health system in the state, with more than 12,000 associates committed to delivering the most efficient, highest quality, faith-based care at nine acute and specialty care hospitals and at more than 80 ambulatory/clinic locations. AMITA Health has an extensive provider network of more than 3,000 hospital-affiliated physicians, and the AMITA Health Medical Group consists of over 500 multi-specialty employed physicians and associate practitioners, ranking it among the largest regional medical groups. AMITA Health's mission is to extend the healing ministry of Jesus by respecting the faith traditions of the many individuals and families it serves across suburban Chicago.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by an FDA-approved pacemaker-like device called the vBloc® System, is designed to help patients feel full and eat less by intermittently blocking hunger signals on the vagus nerve. EnteroMedics recently acquired the Gastric Vest System™ through its acquisition of BarioSurg, Inc. The Gastric Vest is an investigational, minimally invasive, laparoscopically implanted medical device being studied for weight loss in morbidly obese patients. The device wraps around the stomach, emulating the effect of conventional weight-loss surgery, and enables gastric volume reduction without permanently changing patient anatomy.
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. 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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