News and Trends—August 2015

| August 1, 2015

FDA Approves THE ReShape™ INTEGRATED DUAL BALLOON SYSTEM, A FIRST-OF-ITS-KIND NON-Surgical Weight Loss PROCEDURE FOR People with Mild to moderate Obesity
SAN CLEMENTE, California—ReShape Medical® announced that the U.S. Food and Drug Administration (FDA) has approved the ReShape™ Integrated Dual Balloon System, a first-of-its-kind non-surgical weight loss procedure for people with mild to moderate obesity. The ReShape Procedure provides a new option for adults with a BMI of 30–40kg/m2 and a related health condition who haven’t succeeded at diet and exercise alone, and do not want or do not qualify for bariatric surgery.
“Many Americans who face the risk and consequences of obesity have struggled with a lack of effective weight loss options when their BMI is in the 30-40 range,” said John Morton, MD, MPH, President of the American Society for Metabolic and Bariatric Surgery. “Options like ReShape address a significant gap that exists between diet and exercise, weight loss medications and surgery, offering a minimally invasive, reversible option which we hope will promote long-term healthy habits.”
The dual balloon is inserted in the stomach endoscopically and filled with saline. It does not change or alter the natural anatomy in any way and remains in the stomach for six months. During this time and for the six months after the balloon is removed, ReShape patients receive comprehensive counseling and support services that include frequent in-office coaching sessions.
ReShape is a next generation technology with features that are designed to enhance performance in three important areas. First, two connected balloons have a larger fill volume than a typical single balloon.  Second, it is designed for greater comfort by mounting the two balloons on a flexible shaft that allows the device to conform to the natural shape of the stomach.  Finally, the ReShape Integrated Dual Balloon is the only intragastric balloon that is designed to mitigate the potential for migration of a deflated balloon from the stomach into the intestines.
“While intragastric balloons have been used successfully outside of the U.S. for many years, there has been little design improvement or innovation of this treatment,” said Rick Thompson, President and CEO of ReShape Medical. “We looked closely at previous balloons when designing our dual balloon and we feel confident that our unique, next-generation design will help to deliver sustained results and significant life changes for patients.”
The ReShape Integrated Dual Balloon System was evaluated in the REDUCE pivotal trial, the results of which were presented at the 2014 ObesityWeek, the annual meeting of the American Society for Metabolic and Bariatric Surgery and published in the journal Surgery for Obesity and Related Diseases.  In that study, patients that had the ReShape Procedure lost 2.3 times as much weight as a control group that received diet and exercise coaching only. There were also measurable and sustained improvements in co-morbidities and strong patient satisfaction. In a study of the ReShape Procedure in commercial use in Europe, ReShape patients on average lost 47% of their excess weight and maintained 98% of their weight loss at one year.
“Through clinical studies in the U.S. and abroad, ReShape has now been used by hundreds of patients,” said Jaime Ponce, MD, lead investigator on the REDUCE trial. “Positive data from the rigorously designed pivotal study, coupled with commercial experience in Europe, demonstrate that ReShape can provide an important new non-surgical option to help patients in the U.S. lose weight and give them the tools needed to keep it off.”
The company plans to make the ReShape Procedure available to patients first in select markets, as physicians and allied health professionals are trained on the procedure and support program to optimize patient outcomes. The ReShape Procedure, including the 12 months of premium coaching and support, will be available on a self-pay basis and price will vary by healthcare provider and market. Ongoing updates about the availability of the ReShape Procedure can be found at www.ReShapeReady.com/get-started.
About ReShape Medical. ReShape Medical is a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss. Driven by a passion to address the worldwide obesity epidemic, the company has developed a non-surgical alternative for obese patients seeking treatment. Additional company information can be found at www.pro.reshapeready.com. The ReShape device has been available in the European Union since December 2011.

Apollo Endosurgery, Inc. Announces FDA Approval of the ORBERATM Intragastric Balloon, a Non-Surgical Solution to Assist Patients in Weight Loss
AUSTIN, Texas—(BUSINESS WIRE)—Apollo Endosurgery, Inc., a leader in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, announced that the U.S. Food and Drug Administration (FDA) has approved the ORBERA™ Intragastric Balloon to assist adult patients suffering from obesity—with a body mass index (BMI) of 30 to 40 – in losing and maintaining weight.
The ORBERA balloon is part of the ORBERA Managed Weight Loss System, a comprehensive, non-surgical two-part program that includes a balloon filling space in a patient’s stomach to reinforce proper portion control. Data on ORBERA collected in the U.S. clinical trial has shown that the average person lost 3.1 times the weight as compared with diet and exercise alone within six months.
While new to the United States, ORBERA is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results,” said Todd Newton, Chief Executive Officer of Apollo Endosurgery. “ORBERA is a proven, innovative and non-surgical solution to help fight the obesity epidemic and treat patients before their disease progresses and requires more invasive treatments. With the FDA approval of ORBERA, Apollo can now offer this safe and effective solution to patients and their physicians in the United States.”
“For many, the weight loss journey leaves patients with little support or options other than diet and exercise and traditional surgery. The approval of ORBERA fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients with less invasive options that can assist them in reaching their long-term weight loss goals,” said Christine Ren-Fielding, MD, a New York-based bariatric surgeon. “ORBERA gives us a new weight loss option to help address what has become a critical health issue in the United States.”
Introducing ORBERA. ORBERA is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.
In a non-surgical (endoscopic) procedure done under a mild sedative, the thin and deflated ORBERA™ balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure done under a mild sedative, the ORBERA™ balloon is deflated and then removed.
Once the balloon is in place, the patient receives an individually tailored support program through the ORBERATM Managed Weight Loss System team of experts – which may include a dietician, psychologist and exercise physiologist – to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
ORBERA Pivotal Study Results. In the U.S. pivotal ORBERA clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, patients suffering from obesity with a BMI between 30 and 40 were randomized to treatment or control in a 1:1 ratio. The treatment group underwent placement of the ORBERA balloon followed by removal after six months. They concurrently participated in a 12-month behavioral modification program. The control group participated in the 12-month behavioral modification program alone. For patients in the treatment group, the device was removed at month six, with regular office visits continuing through one year.
A total of 125 patients were randomized to the treatment group and 130 patients were randomized to the control group.
Detailed findings from the trial include:
•    At month six, the ORBERA group achieved a mean of 38.4 percent Excess Weight Loss (EWL).
•    Mean Total Body Weight Loss (TBWL) at six months was 10.2 percent for the treatment group compared to 3.3 percent TBWL for the control group.
•    The ORBERA group lost 3.1 times as much weight as the control group at six months.
•    The ORBERA group also lost significantly more weight than the control group over the course of the study, and was able to maintain significant weight loss through month 12, six months after removal of the device.
For more than 20 years, the global medical community has been using intragastric balloons from the makers of ORBERA to help thousands of people lose weight. More than 220,000 ORBERA balloons have been distributed worldwide in over 80 countries.
For additional information regarding ORBERA, please visit Orbera.com.
For full safety information please visit orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA
About Apollo Endosurgery, Inc. Apollo Endosurgery, Inc. is revolutionizing the treatment of obesity and other gastrointestinal disorders by developing less invasive solutions for a whole new group of patients not seeking treatment today. Apollo is a global innovator pushing boundaries to bring new technologies and innovative products to markets in over 80 countries today. In particular, Apollo’s bariatric products fill the gap between non-surgical weight loss solutions and invasive surgeries, allowing physicians to do more for those patients who require more than drug therapy and dietary advice. For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.

New Healthcare Provider Education Tools From STOP Obesity Alliance Now Available
The Strategies to Overcome and Prevent (STOP) Obesity Alliance recently released a website and a series of educational videos for healthcare providers as part of its continued effort to improve communication with patients affected by obesity. The information is based on STOP’s Why Weight? A Guide to Discussing Obesity & Health With Your Patients, a unique tool designed to help providers build a safe and trusting environment with patients to facilitate open, productive conversations about weight. This series is part of a larger effort STOP is making to improve the patient experience and educate health care providers. The Why Weight? A Guide to Discussing Obesity & Health With Your Patients series of information is available at www.WhyWeightGuide.org.
American Board of Obesity Medicine Board Member Scott Kahan, MD, MPH serves as STOP’s medical directory and is featured in the video series, including a dramatization on what health care providers should not do when addressing a patient’s weight.
“One of the most common concerns I hear from physicians is that they have no training in how to talk to patients about weight and obesity. We created this resource to fill this hole,” says Kahan. “I hope that physicians and patients, alike, can benefit from the insights, tools, and guidance in the Why Weight? website.”
Visit http://www.whyweightguide.org/tool-content.php to view an overview of the Why Weight? tool content.
Visit http://www.whyweightguide.org/videos.php to view a series of Why Weight? videos.

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