[SportMed] SPORTS MEDICINE : MEDICAL: CONDITIONS: OBESITY : MEDICAL: DISEASES: DIABETES : MEDICAL: TREATMENTS: FDA Approves ReShape Dual Balloon Device to Treat Obesity

David P. Dillard
 

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[SportMed] SPORTS MEDICINE : MEDICAL: CONDITIONS: OBESITY :

MEDICAL: DISEASES: DIABETES :

MEDICAL: TREATMENTS:

FDA Approves ReShape Dual Balloon Device to Treat Obesity

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FDA Approves ReShape Dual Balloon Device to Treat Obesity

Robert Lowes

Disclosures

July 28, 2015

Medscape

http://www.medscape.com/viewarticle/848767

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The US Food and Drug Administration (FDA) today approved a new nonsurgical weapon in the fight against obesity a pair of connected saline-filled balloons that are temporarily implanted in the stomach to trigger a feeling of fullness and jump-start weight loss.

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The device, called the ReShape Dual Balloon (ReShape Medical), is inserted endoscopically through the mouth and then filled with saline solution. The outpatient procedure takes less than 30 minutes while the patient is mildly sedated.

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The FDA said that the satiety-inducing ReShape Dual Balloon does not alter the stomach's natural anatomy. The intragastric device, which should be removed after 6 months, is meant to accompany a medically supervised diet and exercise program. It is indicated specifically for obese adults with a body mass index of 30 to 40 kg/m2 with one or more obesity-related conditions such as diabetes who have failed to lose weight through diet and exercise alone.

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Physicians in other countries such as Canada, Italy, France, and Brazil have used intragastric, saline-filled balloons for years to treat obesity. The ReShape Dual Balloon has been available in the European Union since December 2011, according to the manufacturer.

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Obesity and Weight Management

FDA approves ReShape intragastric balloon device for weight loss

By: ELIZABETH MECHCATIE,

Clinical Endocrinology News Digital Network

July 31, 2015

http://www.clinicalendocrinologynews.com/specialty-focus/obesity/
single-article-page/fda-approves-reshape-intragastric-balloon-
device-for-weight-loss/e332ab491653df0405a30e2c3a51d5a0.html

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A shorter URL for the above link:

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http://tinyurl.com/oa28js6

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The first intragastric balloonbased device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.

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The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m2; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months maintained 60% of this weight loss through 48 weeks of follow-up, according to the FDA.

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After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the most worrisome device-related risk, but there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations in the study.

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snip

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Information posted by the FDA, including labeling for professionals, is available at

http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfTopic/pma/pma.cfm?num=P140012


OR


http://tinyurl.com/otskepl

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Press Release from the Manufacturer

ReShape is Now FDA Approved in the United States

July 28, 2015

http://pro.reshapeready.com/now-fda-approved-in-the-united-states/


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The complete articles may be read at the URLs provided for each.

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