Analysis of post-market experience using the ReShape Integrated Dual Balloon System in Spain to be highlighted at IFSO 2014 World Congress
MONTREAL and SAN CLEMENTE, Calif., Aug. 28, 2014 /PRNewswire/ -- ReShape Medical® today announced that positive data in support of the ReShape Integrated Dual Balloon System will be highlighted at the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) 2014 World Congress, being held August 26-30 in Montreal, Canada. In a prospective evaluation of 60 patients conducted in Spain, the ReShape Integrated Dual Balloon demonstrated clinically significant weight loss, a favorable safety profile and high patient satisfaction rate.
“As the world’s obesity epidemic continues to grow, it is more critical than ever that we identify additional safe and effective treatment options for those who struggle with their weight,” said the study’s primary investigator Gontrand López-Nava, MD, Director de la Unidad de Tratamientos Endoscópicos de la Obesidad del Hospital Universitario Sanchinarro. “These results show that the ReShape Procedure is both effective and well tolerated, and could provide us another option for patients.”
The evaluation showed that after six months with the balloon in place, patients experienced:
- Mean weight loss = 14.4 ± 7.4kg
- Mean percent total body weight loss = 13.5 ± 6.4%
- Mean percent excess weight loss = 41.7 ± 23.4%
- Very low intolerance rate of <2%
- High satisfaction rate = 84% of patients reporting being satisfied or very satisfied with the procedure
The ReShape Non-Surgical Weight Loss Procedure is designed to help patients lose weight and facilitate behavior change. The Integrated Dual Balloon is inserted endoscopically during an outpatient procedure and remains in the stomach for six months. The balloon takes up space in the stomach and helps patients feel full. While the stomach-filling balloons are in place, patients are counseled by health care professionals on nutrition, exercise and behavior modification to help them develop a healthier lifestyle. This program continues for an additional six months after removal of the balloons to encourage new habits and lasting results.
In July 2014, ReShape Medical submitted a Pre-market Approval application (PMA) for the device to the Food and Drug Administration (FDA). Results from ReShape’s REDUCE US Pivotal trial will be presented as one of the Top Ten papers at Obesity Week this November. Another study from Dr. Lopez-Nava on the repeat use of the ReShape balloon will also be featured at Obesity Week as a Poster of Distinction.
“Dr. Lopez-Nava’s data on the use of the ReShape balloon in Europe demonstrates a very high rate of patient satisfaction, which is one of our key metrics of success with the system,” said Rick Thompson, President and CEO of ReShape Medical. “This result reinforces our company’s momentum, and we look forward to presentation of US randomized, controlled clinical trial results at Obesity Week in the fall.”
At IFSO, Dr. Lopez-Nava’s Poster Presentation, titled “A Prospective Evaluation of a New Dual Intragastric Balloon,” will be on display in Exhibit Hall, Palais des Congres 220ABC.
About ReShape Medical
ReShape Medical is a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss. Driven by a passion to address the worldwide obesity epidemic, the company has developed a non-surgical alternative for obese patients seeking treatment. Additional company information can be found at www.reshapemedical.com. The ReShape device has been available in the European Union since December 2011.
Caution: Investigational device. Limited by Federal (United States) law to investigational use.
Media Contact:
Rachel Gross
MSLGROUP
reshapemedical@mslgroup.com
781-684-0770
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SOURCE ReShape Medical
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