Since it’s debut more than 20 years ago, the Orbera® Intragastric Balloon has made a name for itself as the world’s #1 intragastric balloon weight loss program. This safe and non-invasive procedure from Apollo Endosurgery — a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures — requires no incisions, and has been proven to help patients experience 3.1-times more weight loss than diet & exercise alone.
Now — in a rousing testament to the safety and efficacy of the procedure — the Orbera Intragastric Balloon has received the coveted “Breakthrough Device Designation” from the U.S. Food and Drug Administration; specifically for its indication for use in treating patients with a BMI between 30-40 kg/m2 with noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
As the main intention of the FDA’s Breakthrough Device Program is to help patients receive more timely access to breakthrough technologies — technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions — this impressive distinction only lends further credibility to the countless success stories that real patients have shared about their weight loss experiences with the Orbera Intragastric Balloon.
At Anchorage Bariatrics, we are proud to offer a full spectrum of comprehensive weight loss options. From medication-assisted weight loss and bariatric surgery, to non-surgical options like the Orbera Intragastric Balloon, our experienced Doctors are devoted to helping you take control of your weight, so you can live a healthier and happier life. Read on to learn more about the Orbera’s “Breakthrough Device Designation” from the FDA, and contact us today to schedule a consultation in Anchorage.
What Is Non-Alcoholic Steatohepatitis (NASH)?
NASH is a severe form of fatty liver disease that is most commonly associated with liver inflammation. As NASH can progress to cirrhosis and liver failure, it is one of the top three conditions leading to liver transplants, and if left untreated, puts patients at an increased risk of morbidity and mortality from liver-related causes.
How do you treat NASH?
There are currently no FDA approved treatments for NASH. However, weight loss is the recommended treatment for those seeking meaningful improvements in their condition. As the current recommended treatment guidelines aim for a sizeable, 7-10% Total Body Weight Loss (TBWL), it is exceedingly difficult for patients to achieve the required level of TBWL through diet and exercise alone. Thus, it’s not hard to see why the Orbera Intragastric Balloon has positioned itself as an exciting option for those seeking meaningful improvements in their battle against NASH.
What are the benefits of the Orbera Intragastric Balloon?
There are many benefits of the Orbera Intragastric Balloon, including but not limited to:
- No surgery – Performed endoscopically by a gastroenterologist
- Quick procedure – It only takes 15 minutes to place the balloon
- Significant results – On average, patients lose 3.1 times more weight than diet and exercise alone
- Fast weight loss – The majority of weight loss typically occurs in the first three months of treatment
- Affordable – Ask us about our competitive pricing for patients in Anchorage
- Non-permanent – A highly effective, reversible procedure for rapid weight loss
According to a study conducted by the Mayo Clinic, Orbera Intragastric Balloon procedures showed a notable improvement to Non-Alcoholic Fatty Liver Disease Activity Scores, histologic regression of fibrosis (scarring), and magnetic resonance elastography (MRE), when the Orbera was removed after six months.
The Orbera Intragastric Balloon Procedure
The procedure is quick and easy:
- Step 1 – The patient is safely sedated.
- Step 2 – A gastroenterologist endoscopically inserts the thin and deflated Orbera balloon into the stomach.
- Step 3 – The balloon is filled with saline until it is about the size of a grapefruit.
It’s that simple! The procedure itself only takes around 15-20 minutes, and the patient is able to leave the clinic after a couple of hours of recovery. After a period of up to six months, the patient will return to have the balloon deflated and removed.
The Breakthrough Device Designation – Hope for Those Suffering From NASH
As there are currently no FDA approved treatments for NASH, and the Total Body Weight Loss (TBWL) metrics for those seeking meaningful improvements through weight loss are staggeringly high (7-10% TBWL), Obera’s Breakthrough Device Designation is a sign of hope for those struggling with NASH. Dr. Christopher Gostout — Apollo Endosurgery’s Chief Medical Officer — summarized this as follows:
“The literature and the Mayo IDE study suggest that these levels of weight loss can have a positive effect in resolving or delaying the progression of NASH. With Breakthrough Designation, we will be able to further build the body of clinical evidence and seek label expansion for the use of Orbera for patients with NASH.”
Schedule a Consultation with Anchorage Bariatrics
The Orbera Intragastric Balloon is a safe and effective weight loss procedure that requires no incisions. For adults suffering from obesity — but not interested in or appropriate for surgery — Orbera is an effective and affordable solution for achieving rapid levels of weight loss not attainable through diet and exercise alone. At Anchorage Bariatrics, we are passionate about connecting our patients with the best weight loss procedures for their unique needs. You don’t need to be a NASH patient to qualify for this simple, life-changing weight loss procedure — contact us today to schedule a consultation in Anchorage!