News and Trends—January 2015

| January 1, 2015

Announcement: FDA Approval of EnteroMedics VBLOC® Vagal Blocking Therapy
First New Medical Device Approved for Obesity in Over a Decade
EnteroMedics Inc. (St. Paul, Minnesota) announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC® vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients with obesity who have a body mass index (BMI) of at least 40 to 45kg/m2, or a BMI of at least 35 to 39.9kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years.

The Maestro System is a pacemaker-like device that is implanted, usually in an outpatient procedure, to control both hunger and fullness by intermittently blocking the primary nerve regulating the digestive system, the vagus nerve. VBLOC Therapy does not surgically alter or restrict the digestive system, does not create barriers to prevent absorption of nutrients and is completely reversible, allowing patients to lose weight without lifestyle compromises.

“VBLOC Therapy offers an entirely new approach to the treatment of obesity,” said Scott Shikora, MD, FACS, EnteroMedics’ Chief Consulting Medical Officer. “By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss.”

EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received the CE Mark and is listed on the Australian Register of Therapeutic Goods.

If you are interested in learning more about VBLOC Therapy, please visit www.enteromedics.com/vbloc or call 1-800-MY-VBLOC

New York-Presbyterian Hospital/Weill Cornell Medical Center Develops New Procedure to Alleviate Common Side Effects for Gastric Bypass Patients  
NEW YORK, New York—Gastric bypass surgery has become an increasingly popular treatment option for the some 30 percent of Americans struggling with obesity. However, many gastric bypass patients struggle with side effects from the procedure, which are difficult to treat due to the patients’ surgically-altered digestive tract. In order to more effectively treat these conditions, New York-Presbyterian/Weill Cornell Medical Center developed EUS-Directed Transgastric ERCP (EDGE), the first minimally invasive procedure to treat pancreaticobiliary diseases in gastric bypass patients.

“With the EDGE procedure, patients with gallstones and other causes of bile duct obstruction can usually be treated without the need for open surgery, which improves recovery time and greatly increases their comfort,” said Dr. Michel Kahaleh, chief of endoscopy in the division of gastroenterology and hepatology at New York-Presbyterian/Weill Cornell Medical Center and a professor of medicine at Weill Cornell Medical College, who developed the EDGE procedure. “We’re proud to be the first hospital to successfully treat gastric bypass patients using this technique.”
Altered anatomy presents treatment challenges. In gastric bypass surgery, a small pouch is created from the patient’s stomach, with the remainder of the stomach cut off from the passage of food. The pouch is then connected to the small intestine to allow the digestive process to occur. Due to the rapid weight loss caused by the procedure, gallstones and bile duct obstructions are common side effects in gastric bypass patients. Nearly 50 percent of patients who undergo the most common gastric bypass procedure develop gallstones and 25 percent may have their gallbladder removed.
“When surgeons perform gastric bypass, they alter the anatomy to ensure that patients lose weight,” said Dr. Kahaleh. “But the reconfigured stomach and intestines makes it difficult to access the bile duct and gallbladder through minimally invasive procedures.”

EDGE offers an effective solution. Dr. Kahaleh developed EDGE based on his extensive experience using the AXIOS, a lumen apposing metal stent, which is used to treat conditions such as pancreatic pseudocysts and bile duct obstructions. Using AXIOS, he connects the accessible pouch to the excluded stomach. While the stent is in place, a specialized endoscope can extract the gallstone and drain the pancreas or the bile duct internally without using surgery. During that process the bypass is temporarily rendered ineffective. Once the lumen apposing metal stent is removed and the pouch closed a few weeks later, the bypass efficiency is restored. Since April 2014, five gastric bypass patients with gallstones or obstructed bile ducts have been successfully treated with EDGE without experiencing weight gain. The patients did not have to undergo open surgery, which saves recovery time and costs.

About New York-Presbyterian/Weill Cornell Medical Center. New York-Presbyterian/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital New York-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. New York-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances—including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.S.; the first clinical trial for gene therapy for Parkinson’s disease; the first indication of bone marrow’s critical role in tumor growth; and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. New York-Presbyterian Hospital also comprises New York-Presbyterian/Columbia University Medical Center, New York-Presbyterian/Morgan Stanley Children’s Hospital, New York-Presbyterian/Westchester Division, New York-Presbyterian/The Allen Hospital, and New York-Presbyterian/Lower Manhattan Hospital. The hospital is also closely affiliated with New York-Presbyterian/Lawrence Hospital in Bronxville. New York-Presbyterian is the #1 hospital in the New York metropolitan area, according to U.S. News & World Report, and consistently named to the magazine’s Honor Roll of best hospitals in the nation. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit www.nyp.org and weill.cornell.edu.

BARIMARK LLC is pleased to announce a new nationwide distribution alliance with PatchMD™
CHILLICOTHE, Ohio and LAGUNA NIGUEL, California—BARIMARK LLC, a bariatric marketing company located in Chillicothe Ohio, will begin nationwide distribution of PatchMD™ (Laguna Niguel, California) products December 2014. BARIMARK, founded in March 2014, has developed many support services for bariatric surgeons and patients. Since March 2014, the company has launched the following four marquee services that support the bariatric industry:
•    Baridex.com: A bariatric directory dedicated to serving the bariatric industry by allowing premium listings for vendors, surgeons, and bariatric professionals.
•    The Journey Brochure: A patient concierge brochure that assists new patients entering into bariatrics in understanding the industry and becoming quickly connected to useful services.
•    Outbound Call Center (OCC): Dedicated to serving bariatric business, BARIMARK’s outbound call center has handled thousands of calls since inception. BARIMARK’S OCC calls upon bariatric business to support vendors, hospitals, market research, lead acquisition, and patient follow-ups.
•    BariMart.com: the newest of BARIMARK’s brands launched in November of 2014 with immediate strong success.  BariMart is an online retail store that features the major vitamin, protein, and vendors products found with the bariatrics industry.

Utilizing the networked and overlapping of these services, BARIMARK LLC, will begin supporting the nationwide distribution of PatchMD topical vitamin patches.

PatchMD products utilize the same proven topical delivery methods found in many prescription pharmaceutical patches. What makes PatchMD perfect for bariatric use is the ability to bypass the malabsorption process associated with many bariatric surgeries in favor of topical absorption.
Recently, PatchMD announced a new multi-vitamin patch that “Exceeds ASMBS Guidelines”.  The new bariatric Multi-Vitamin Patch was designed specifically to exceed the ASMBS guidelines and deliver micronutrients in the same dosage requirements prescribed by the society. The new bariatric Multivitamin Plus patch shipped on December 17, 2014 and is available nationwide, immediately via BariMart.com or BariMark Wholesale.

PatchMD’s Bariatric Multi-Vitamin Patch is a daily patch application that is cost effective ($19.95 per month for 30 patches) and provides proven results for increased absorption rates over traditional oral supplementation.

PatchMD carries other essential supplements including: B12 at 1000mcg, D3 5000 IU with calcium, glucosamine (Joint Flex), and garcinia cCambogia 1600mg.
PatchMD products are already in high use in other medical fields and were recently introduced to bariatrics during a ObesityHelp event; where the product was well received by both patient and professionals.

About PatchMD. The founders of PatchMD have over 60 years of combined experience in both the over-the-counter pharmaceutical trade and the medical device products industry. The company was founded to offer “the very best in patch technology.”
Every topical patch is manufactured according to specific set of precise specifications. Upon completion, our expert staff conducts a finished product analysis on samples taken directly from the production line. Testing continues even after manufacturing has been completed, as retained samples are kept a year past the expiration date. Our ongoing goal is to acquire as much knowledge as possible about our products, ensuring that safety and reliability are maintained over an extended period of time.

To learn more about PatchMD, please visit the company website at www.patchmd.com

About BARIMARK LLC. BARIMARK is a bariatric marketing company that exists to help meet the changing needs of the bariatric industry through personal attention, service-line support, and a commitment to excellence. In 2014, BARIMARK serviced more than 60 companies and practices nationwide. BARIMARK’s list of clients grows every month as the company continually innovates and expands it’s products and services.

To learn more about BARIMARK LLC, please visit the company website at www.barimark.com.
If you wish to become a distributor of PatchMD products please contact BARIMARK at 866-233-8022 or via email at orders@barimark.com

American Board of Obesity Medicine Announces New Support from Two Groups
1.) American College of Physicians
DENVER, Colorado—In an effort to provide candidates and American Board of Obesity Medicine (ABOM) Diplomates access to a variety of resources dedicated to education on the topic of obesity medicine, the ABOM collaborates with numerous organizations across the United States and Canada. ABOM is pleased to add the American College of Physicians to this growing group.
The American College of Physicians (ACP) is a national organization of internists – physician specialists who apply scientific knowledge and clinical expertise to the diagnosis, treatment, and compassionate care of adults across the spectrum from health to complex illness.
ACP Senior Vice President for Medical Education Dr. Patrick Alguire explains how obesity medicine education fits into the overall mission of the ACP.

“Over one-third of adults in the United States are obese and the numbers continue to rise,” said Dr. Alguire. “Obesity is associated with an increased risk of heart disease, hypertension, dyslipidemia, type 2 diabetes, stroke, osteoarthritis, sleep apnea, and cancer. The American College of Physicians is strongly committed to providing obesity-related education to health care practitioners.”
The ACP offers many opportunities for physicians to satisfy Continuing Medical Education (CME) requirements for ABOM certification and recertification. Visit http://abom.org/cmeathome/ for a listing of ACP’s obesity-related, at-home CME offerings. Visit http://im2015.acponline.org/ to learn more about the ACP’s next annual conference, to be held in Boston from April 30 to May 2, 2015.

2.) The American Gastroenterological Association
DENVER, Colorado—In an effort to provide candidates and American Board of Obesity Medicine Diplomates access to a variety of resources dedicated to education on the topic of obesity medicine, the ABOM collaborates with numerous organizations across the United States and Canada. ABOM is pleased to add the American Gastroenterological Association to this growing group.

The American Gastroenterological Association (AGA) is a national organization of gastroenterologists and includes more than 16,000 members worldwide who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA offers many opportunities for physicians to satisfy Continuing Medical Education (CME) requirements for ABOM certification and recertification.

In a statement, the AGA said: The American Gastroenterological Association (AGA) is proud to partner with ABOM in offering CME-related programs to physicians interested in obesity care. As obesity becomes a global problem, it is harder for government, institutions and individuals to continue to consider obesity as a problem of personal choice that can be controlled and even reversed by deciding to eat less and exercise more. The incidences of diabetes and other debilitating diseases attributable to obesity continue to rise along with the negative impact on health-care budgets and various sectors of the economy leading to changing attitudes about the obesity epidemic.
Visit http://abom.org/cmeathome/ for a listing of AGA’s obesity-related, at-home CME offerings. Visit http://www.ddw.org/ to learn more about the AGA’s next annual conference, Digestive Disease Week®, which is held each May and is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Obesity-related courses to be held during the conference May 16 to 19, 2015 in Washington, D.C. include:
•    Nutrition, Epigenetics and Metabolic Programming
•    Eating Fat: The Good, The Bad and The Ugly
•    Endoscopic Management of Obesity
•    Models that Drive Obesity and Its Complications
•    Bariatric Complications: Bariatric Surgery in 2015

Special Announcement from the American Society of Bariatric Physicians: New Resource Helps Diagnose and Treat Obesity
Aurora, Colorado—The Obesity Algorithm, presented by the American Society of Bariatric Physicians (ASBP), has undergone significant updates and now includes more information than ever about treating patients affected by obesity! Download the Obesity Algorithm for free at www.ObesityAlgorithm.org.
Updates included in the 2015 version of the algorithm are:
•    ASBP’s definition of obesity
•    An emphasis on the multifactorial nature of obesity
•    The effects of sleep disorders on obesity
•    The genitourinary and reproductive adverse consequences of obesity
•    The genetic, extragenetic, and epigenetic aspects of obesity
•    The pathophysiology of stress in obesity
•    The effects of non-obesity-related medications on weight
•    An explanation of motivational interviewing and change evocation
•    A description of each of the available weight-management medications

The Obesity Algorithm is an educational tool that offers health care providers an overview of principles that are necessary to consider when evaluating patients and implementing personalized treatment plans for patients affected by obesity. Within these plans are options for nutrition strategies, exercise prescription, behavior modification, weight-management medications, and discussion of surgical options. In addition to weight loss, the algorithm emphasizes optimizing health, decreasing disease risk, and improving overall quality of life.

Download the new Obesity Algorithm now at www.ObesityAlgorithm.com. Upon clicking the link to download, you will be redirected to the license agreement, which you must complete and agree to before receiving a link to the downloadable PowerPoint presentation. Please note that if you have already filled out the license agreement for a previous version of the algorithm, you still must complete and resubmit the license agreement to receive a link to the updated file.
Please contact ASBP at info@asbp.org or 303.770.2526 if you have any questions.

Obesity Action Coalition (OAC) Welcomes Amber Huett-Garcia, MPA, BS, as Vice-Chairman of the Coalition and Sarah Bramblette to the National Board of Directors
Tampa, Florida—The OAC is proud to announce Amber Huett-Garcia, MPA, BS, as Vice-chairman of the Coalition. Amber is a longtime OAC member and has served on the OAC National Board since 2012. She is the past-Chair of the OAC Convention Planning Committee where she led for three years and most recently helped to develop the Convention Scholarship Program. She continues to serve on the Convention Planning Committee as well as the Revenue Generation Committee. She is also the recipient of the 2014 OAC Chairman’s Award. Ms. Huett-Garcia is a director at Teach for America and lives in Memphis, Tenn.

“I am extremely excited to have Amber as Vice-chairman of the OAC. Her leadership on the Board, and with the OAC’s National Convention, has been monumentally beneficial to the organization in a variety of ways. I look forward to working with her,” said Ted Kyle, RPh, MBA, OAC Chairman.
The OAC also welcomed Sarah Bramblette to the National Board of Directors. As an OAC member since 2012, Sarah has dedicated herself to raising awareness of the OAC, weight bias and the disease of obesity. In 2014, she was honored with the OAC Member of the Year Award for her support of the OAC’s mission and goals. She was featured in the OAC’s Your Weight Matters Magazine and was also the first-place winner of HealthCentral’s #LiveBold Anti-stigma Photo Contest. She is a lipedema, lymphedema, obesity, and health insurance advocate and is currently working toward a master’s degree in health law.

“We are very excited to have Sarah on the OAC National Board. Her contributions to the OAC have been tremendous, and we look forward to her thoughts and knowledge as a director,” said Joe Nadglowski, OAC President and CEO.

The OAC National Board of Directors are as follows: Ted Kyle, RPh, MBA, Chairman of the Board; Amber Huett-Garcia, MPA, BS, Vice-chairman; Pam Davis, RN, BSN, CBN, Immediate-Past Chairman, Georgeann Mallory, RD, Treasurer; Michelle Vicari, Secretary; Tammy Beaumont, BSN, RN, CBN; Sarah Bramblette; Jaime Fivecoat, MBA; Robert Kushner, MD; Holly F. Lofton, MD; Tracy Martinez, RN, BSN, CBN; Walter Medlin, MD, FACS; Lloyd Stegemann, MD; and Melinda J. Watman, BSN, MSN, CNM, MBA

The 2015 Board of Directors’ slate was presented to the membership in November 2014. We invited our members to review the slate and submit their own candidate, if desired. The OAC received full support of the slate and we now welcome Sarah to the Board. For more information on the OAC National Board of Directors, please visit the OAC Web site at www.ObesityAction.org.
The Obesity Action Coalition (OAC), a nearly 50,000 member-strong National non-profit organization, is dedicated to improving the lives of individuals affected by the disease of obesity through education, advocacy and support.

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