News | Renaissance School of Medicine at Stony Brook University

<P><B><BIG>NEW BALLOON FOR NON-SURGICAL WEIGHT LOSS GAINS FDA APPROVAL</BIG></B></P>

<strong><font color="#990000"><I>Successful Trial of Gastric Balloon Here at Stony Brook Helped Prove Its Value</I></font></strong>

<div class="caption"><table width=180><tr><td>Dr. Aurora D. Pryor, Director of the Stony Brook Bariatric and Metabolic Weight Loss Center</td></tr></table></div></div>

<P>STONY BROOK, NY, September 8, 2016 — Today, the <a href="http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceap…; target="_blank">U.S. Food and Drug Administration (FDA)</a> approved the novel <a href="http://www.obalon.com/" target="_blanl">Obalon gastric balloon for weight loss</a> following its recent national clinical trial. This is exciting news for us and for members of our community who need to lose weight. Now we have another non-surgical treatment option.</P>

<P><a href="/surgery/people/faculty/dr-aurora-d-pryor">Aurora D. Pryor, MD</a>, director of the Stony Brook Bariatric and Metabolic Weight Loss Center, and chief of our <a href="/surgery/divisions/general-surgery">Bariatric, Foregut, and Advanced Gastrointestinal Surgery Division</a>, was a leader of the national Obalon trial and served as principal investigator of the balloon's trial here at Stony Brook Medicine.</P>

<P>In fact, the Stony Brook-based Obalon trial made news in May, and was featured on ABC Eyewitness News. The focus of that story was on a Stony Brook patient who was treated with the Obalon gastric balloon and who lost 27 pounds in six months.</P>

<P>This patient had three balloons put in her stomach over a 12-week period, with the goal of making her feel full most of the time.</P>

<P><div class=callout><P><B>
"It was 27 pounds honestly I wouldn't have been able to lose on my own."
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<P>"I would only eat or even drink a certain amount," she said on the news. "And I was like, OK. It was 27 pounds honestly I wouldn't have been able to lose on my own."</P>

<P>This patient had enrolled in the Obalon trial directed by Dr. Pryor.</P>

<P>Commenting on the FDA's approval of the Obalon balloon, Dr. Pryor says: "We participated in the Obalon clinical trial, and are excited to now have the Obalon Balloon System readily available for our patients who have been frustrated by not being able to lose weight through diet and exercise alone.</P>

<P>"The Obalon balloon is swallowable, can typically be placed in less than 10 minutes without the use of sedation or anesthesia, and was well-tolerated by our patients in the clinical trial. Now that it has received FDA approval, we can begin treating more patients with the device."</P>

<P>In the national clinical trial, 387 patients across fifteen clinical trial sites were randomized in a double-blind, sham-controlled study. The patients in the clinical trial received either three Obalon balloons or three sham placebo-like devices that looked similar to the balloons, but were filled with sugar.</P>

<P>The patients in both groups were given minimal diet counseling of 25 minutes every three weeks. Both co-primary weight loss endpoints were met, with approximately 65% of patients who received the Obalon balloon experiencing clinically meaningful weight loss of at least 5% of their total body weight, which is twice as many people than in the sham-control group.</P>

<P><div class=callout><P><B>
Gastric balloons are for people who are trying to lose around 30 to 50 pounds.
</B></P></div></P>

<P>The clinical trial data will be presented at <a href="http://obesityweek.com/?gclid=CPnYmo7Tj88CFYsmhgodkqcCAw" target="_blank">Obesity Week</a> this fall in New Orleans.
Dr. Pryor started the trial at Stony Brook in the spring of last year and completed it this spring.</P>

<P>The Obalon balloon includes a small capsule attached to a slender tube. The patient swallows the capsule, and follow it with a glass of water. No sedation is required. Gas is used to inflate the balloon, and the tube is removed.</P>

<P>Once in place, the balloon resides at the top of the stomach so the patient will feel full sooner. Up to three balloons can be placed to continue to facilitate weight loss over the 12-week treatment. At the end of this period, the balloons are removed in a short endoscopic (non-surgical) procedure.</P>

<P>At the same time, patients undergo a rigorous dietary program with nutritionists. "It's going to help teach you about a good lifestyle, good, healthy choices of food," Dr. Pryor says. "All that while you're going through the balloon. And when the balloon comes out, though, it's up to you to maintain that. So that's where the education is important."</P>

<P>A national leader in the field of bariatrics, Dr. Pryor was the first in Suffolk County to use balloon placements for weight loss treatment. She currently offers eligible patients treatment with another FDA-approved gastric balloon called the <B>Orbera balloon</B> (<a href="/surgery/blog/offering-new-nonsurgical-gastric-balloon-weight-loss-treatment" target="_blank">read more</a>).</P>

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"We're excited to bring this novel technology to the approximately 70 million adults in the United States who are struggling with obesity. For physicians, we believe that the Obalon technology represents an important new option for both their practices and their patients who are obese and looking to lose weight," comments Andy Rasdal, chief executive officer of Obalon Therapeutics. "I'd also like to recognize the FDA for their efficient and interactive review of our product, which represents another option for physicians and patients in the battle against the obesity epidemic."
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<P><span class="pointer"><B>For consultations/appointments to <font color="#990000">learn more about our balloon treatments</font> for weight loss, call 631-444-2274. Watch the ABC <a href="#" onClick="window.open('http://abc7ny.com/video/embed/?pid=1344350','Could Implanted Balloons Help You Lose Weight?','resizable,height=276,width=420'); return false;">news video about our Obalon trial</a>.</B></span></P>