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FDA product process

ReShape Duo device will not face FDA advisory panel

Company expecting a decision from the FDA during the 1st half of 2015

ReShape Medical will not have to attend an FDA advisory committee as part of its regulatory path to commercialise a balloon system to combat obesity - the ReShape Duo device – reports The company previously anticipated a launch in the US in mid-to-late 2015, after the company submitted its PMA application in June 2015, and is expecting a decision from the FDA during the 1st half of 2015.

The ReShape 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.

REDUCE US pivotal trial

The most recent outcomes from the REDUCE US pivotal trial presented in November 2014 ObesityWeek 2014, demonstrated that patients who underwent the ReShape procedure lost 2.3 times more excess weight at six months compared to control patients treated with diet and exercise alone. There were significant and sustained improvements in co-morbidities and strong patient satisfaction, along with maintenance of two-thirds of the weight loss, through twelve months of study follow up.

Detailed findings from the trial with subjects who completed the study include:

  • The ReShape Procedure produced more than twice the weight loss (28% EWL) compared to patients treated with medically supervised diet and exercise alone (12% EWL).
  • 55% of patients treated with the ReShape Procedure lost at least 25% of their excess weight.
  • Significant and sustained improvements in co-morbidities were observed through the 24 week treatment phase, and these improvements continued for an additional 24 weeks after the Integrated Dual Balloon was retrieved. These included reductions in triglycerides, high and low density lipoproteins, systolic and diastolic blood pressures, and waist and hip circumferences.
  • Two-thirds of mean weight loss achieved during the treatment phase was maintained for the 24 weeks after the Integrated Dual Balloon was retrieved.
  • The ReShape Procedure had a favorable safety profile, with no migrations or obstructions reported.
  • 66% of trial patients said they would have the ReShape Procedure again and 75% said they would recommend it to a friend in a follow-up survey.

The ReShape device has been available in the European Union since December 2011.

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