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IFSO’14

Reshape data shows clinically significant weight loss

84% of patients reporting being satisfied or very satisfied with the procedure

New positive data seems to support use of the ReShape Integrated Dual Balloon System by demonstrating clinically significant weight loss, a favourable safety profile and high patient satisfaction rate.

Presented at the XIX IFSO World Congress in Montreal, Canada, by the study's primary investigator, Dr Gontrand López-Nava, (Director de la Unidad de Tratamientos Endoscópicos de la Obesidad del Hospital Universitario Sanchinarro, Spain), the evaluation showed that after six months with the balloon in place, 60 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

"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 Dr López-Nava. "These results show that the ReShape Procedure is both effective and well tolerated, and could provide us another option for patients."

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 counselled by health care professionals on nutrition, exercise and behaviour modification to help them develop a healthier lifestyle. This programme continues for an additional six months after removal of the balloons to encourage new habits and lasting results.

"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 randomised, controlled clinical trial results at Obesity Week in the fall."

In July 2014, ReShape Medical submitted a PMA application for the device to the FDA. Results from ReShape's REDUCE US Pivotal trial will be presented as one of the Top Ten papers at Obesity Week in November 2014. 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.

The ReShape device has been available in Europe since December 2011, but is an investigational device in the US.

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