FDA Approves Non-Surgical Solution ORBERA™
To Assist Patients With Weight Loss
The U.S. Food and Drug Administration has approved the ORBERA™ Intragastric Balloon to assist adult patients suffering from obesity in losing and maintaining weight loss. Obesity affects more than 78.6 million U.S. adults and is one of the leading causes of preventable deaths in the U.S. In 2008, an estimated $147 billion was spent in medical costs for obesity. If obesity trends continue, it’s estimated that related medical costs could rise by $43 to $66 billion each year in the U.S. by 2030.
“In light of the obesity epidemic, it’s promising to see such innovative weight loss solutions like ORBERA™ being made available to patients suffering from obesity who are not appropriate for or considering invasive surgery,” said Dr. Marina Kurian, Chair of SAGES Endoscopic Bariatric Task Force and Bariatric Surgeon at New York University Langone Medical Center.
ORBERA™ is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, 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.
“Obesity is a chronic disease and the development of new, minimally invasive solutions, can possibly help stem this epidemic by treating patients before their disease progresses and requires further invasive procedures,” said Dr. Matthew Kroh, co-chair of SAGES Endoscopic Bariatric Task Force and Director of Surgical Endoscopy at the Cleveland Clinic. “Though intragastric balloons offer a non-surgical treatment option for patients, different than current therapies, they should always be offered in a comprehensive bariatric care center with proper patient follow up and dietary guidance to promote the best outcomes,” added Dr. Kroh.
Interventional endoscopists can place ORBERA™ in an outpatient setting. Many patients may receive this as a primary treatment for obesity while others may use this temporarily as a bridge to safer laparoscopic surgery. The intragastric balloon is a six month intervention at which point it is removed. Patients remain in a structured dietary program for a year so that weight lost is maintained. The device has been approved for patients with a body mass index (BMI) of 30-40 with unsuccessful attempts at weight loss and should be placed for obese patients enrolled in a structured weight loss program.
For additional information regarding ORBERA™, please visit www.ORBERA.com.
SAGES has been at the forefront of best practices in endoscopic and laparoscopic surgery by researching, developing and disseminating the guidelines and training for standards of practice in surgical procedures. SAGES Guidelines for Clinical Application of Laparoscopic Bariatric Surgery, were issued in 2008 and are a series of systematically developed statements to assist physicians’ and patients’ decisions about the appropriate use of laparoscopic surgery for obesity. Guidelines are available at http://www.sages.org/publications/guidelines/guidelines-for-clinical-application-of-laparoscopic-bariatric-surgery.
The mission of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) is to improve quality patient care through education, research, innovation and leadership, principally in gastrointestinal and endoscopic surgery. SAGES is a leading surgical society, representing a worldwide community of over 6,000 surgeons that can bring minimal access surgery, endoscopy and emerging techniques to patients worldwide. The organization sets the clinical and educational guidelines on standards of practice in various procedures, critical to enhancing patient safety and health.
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