FDA-Approved

ReShape Medical Weight Loss Device Gets FDA Approval

FDA Approved A new non-surgical and non-permanent option for weight loss is now approved to treat obesity in the United States, the ReShape Integrated Dual Balloon System.

The U.S. Food and Drug Administration approved the ReShape System on July 28, 2015 after a review of study results and finding the medical device proved safe and effective in clinical trials.

The ReShape weight loss procedure is a gastric balloon system that offers patients proven weight loss without surgery, dual balloon technology for increased satiety, comfort, and safety, and one year of diet and exercise counseling to maximize satisfaction and success.

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ReShape Duo Weight Loss Balloon System

Weight Loss Balloons Prove Successful in US Pivotal Trial

ReShape Duo Weight Loss Balloon SystemThe ReShape Duo Intragastric Balloon System can boost weight loss and improve comorbidities, safely, effectively, and with a high patient satisfaction rate, according to results of the REDUCE US Pivotal Trial.

Weight loss balloons are designed to fill up space in the stomach and assist with weight loss by limiting food intake and reducing feelings of hunger. Although the method is currently under investigational status in the United States, it has been used in other parts of the world since 1997.

The study results were submitted to the US Food and Drug Administration (FDA) in July, and a decision by the FDA is expected by the middle of next year. The FDA has yet to approve, but the results support the ReShape Duo as a potential new treatment option for overweight patients.

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ReShape Duo Weight Loss Balloon System

REDUCE Clinical Trial Seeks Patients for Free Weight Loss Procedure

ReShape Duo Weight Loss Balloon SystemResearchers are currently recruiting patients to participate in the REDUCE Clinical Trial, a study sponsored by ReShape Medical to evaluate the ReShape Duo Weight Loss Balloon System.

The ReShape Duo is a gastric dual-balloon designed to occupy space in the stomach to reduce food capacity so you feel full and satisfied with smaller amounts of food. The device is inserted into the stomach via endoscopic techniques and does not involve surgery or incisions.

Individuals who qualify for the procedure and choose to participate in the REDUCE Clinical Trial will receive all study-related care at no cost, including the ReShape Duo Balloon System and a comprehensive weight loss support program.

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ReShape Duo Weight Loss Balloon

Weight Loss Intragastric Balloon Safe, Effective and Easy to Use

ReShape Duo Intragastric BalloonThe intragastric dual balloon is safe, easy to use, and boosts weight loss, according to results of a small study recently published in Surgery for Obesity and Related Diseases.

Intragastric balloons are designed to occupy space within the stomach to help patients feel full and satisfied with less food. The device can be left in the stomach for up to six months. Weight loss success depends on patients adopting lifestyle changes, including a healthier diet and increased physical activity.

Clinical trials are ongoing to win FDA approval for use in the United States. As for now, the intragastric balloon is available in Canada, Europe, South America, and other parts of the world.

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ReShape Balloon

First Patient Fitted With ReShape Balloon Non-Surgical Weight Loss Device

ReShape Gastric BalloonsReShape Medical has announced that the first patient has been fitted with the ReShape Dual Balloons, thus launching the start of a U.S. Investigational Device Exemption (IDE) clinical study into the safety and effectiveness of this non-surgical device for weight loss.

According to the company press release, the ReShape Balloons are designed to be a treatment for the millions of individuals who are overweight and struggle with weight loss, but either do not qualify for weight loss surgery or do not want to undergo one of the surgical options such as gastric bypass or lap band surgery.

The ReShape procedure involves placing inflatable gastric balloons into the stomach to occupy existing space in order to reduce food capacity and lessen hunger sensations. This method does not alter the natural anatomy of the body in any way.

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