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REDUCE Trial

Duo Intragastric Balloon meets primary efficacy endpoints

The double balloon design also allows for a greater ‘fill volume’
Company to submit a PMA to the FDA in 2014 and anticipates a launch in 2015

ReShape Medical has announced that its REDUCE Trial for the ReShape Duo Intragastric Balloon, has met its primary efficacy endpoints. The trial, which reached full enrolment in less than six months, involved eight US sites and studied 326 patients. The company is the first medical device company to successfully meet its primary efficacy endpoints in a US, randomised, sham-controlled pivotal trial for weight loss.

Jamie Ponce

“Meeting the primary endpoints is an important accomplishment, as it convincingly demonstrates the superiority of the ReShape procedure over diet and exercise alone,” said Dr Jaime Ponce, Dalton, Georgia, Principal Investigator in the REDUCE trial. “The ReShape procedure offers a new alternative to help patients kick-start weight loss and learn new behaviours. We are excited about what this new treatment option may do for millions of people needing to lose excess weight.”

The ReShape Duo dual-intragastric balloon is endoscopically placed down the esophagus and into the stomach, with a procedure that does not require any incisions, sutures or fixation to the body. The balloons are inflated with saline and take up much of the stomach’s volume, causing patients to eat smaller portions and to feel full sooner. The device does not change or alter the patient’s anatomy and is fully reversible. During the 24 week treatment period, patients work with dieticians, doctors and nurses to learn healthy diet and exercise habits to help them during and beyond the treatment period.

ReShape Duo design

“There are other technologies that involve a single balloon, however the ReShape Duo design has two discreet balloons,” added Ponce. “The double balloon design also allows for a greater ‘fill volume’ but conforms to the stomach’s natural curvature to improve comfort, without excessively distending the stomach wall.”

He explained that there is a risk with single balloons deflating and migrating into the intestines, potentially causing blockages. The ReShape Duo’s double balloons are filled with saline and a blue indicator dye. If one balloon deflates, the patient will notice blue urine but there is another balloon still inflated that prevents migration into the intestines. The ReShape Duo is the only intragastric balloon that has an anti-migration feature.

Prior to insertion of the device, an endoscopic examination of the stomach is performed to ensure that there are no anatomical contraindications to placement of the device. The ReShape Duo would not be placed if this examination identified the presence of a large hiatal hernia, significant gastritis, an ulcer or a tumour.

REDUCE Trial

There were two primary efficacy endpoints:

  • comparison of percent excess weight loss between treatment and control groups and;
  • percent excess weight loss responder rate in the treatment group

The first endpoint measured the percent of excess weight loss between the group of patients who received the balloon and the group of patients who did not receive the balloon.

“I’m encouraged about what ReShape Duo may do for millions of people who need to lose excess weight,” said Ponce. “The ReShape Duo is designed to initiate and maintain significant weight loss, without the invasiveness of surgery or potential side effects of medication. It is used in conjunction with a comprehensive lifestyle modification patient program to foster long-term success.”

“While the intragastric balloon is in place, patients are counselled by healthcare professionals on nutrition, exercise and behaviour change to help them connect the value of eating small portions with long-term weight control,” he added. “This programme continues following removal of the balloon to encourage new habits – and lasting results.”

Intragastric balloons

Modern intragastric balloons, used over the last 10 years, outside of the US, have proven to be effective with thousands of patients studied and reported in medical literature. Intragastric balloons have been available in Europe for a decade, and there is no question that they are effective in achieving significant weight loss.

Richard Thompson

“Being the first device company to meet its primary efficacy endpoints in a randomised obesity trial is an important step forward on the path to FDA approval,” said President and CEO of ReShape Medical, Richard Thompson. “We saw very significant interest in participation in this study, and are looking forward to bringing the first, non-surgical weight-loss device to the US market, where ReShape Duo has the potential to help patients lose significantly more weight than diet and exercise programmes alone.”

He explained that there are currently no non-surgical options available to patients in this market and the company believes the ReShape procedure will be the first, non-surgical, weight loss device commercialised in the US market.

“Overall feedback from both the US and European clinical work we have done suggests that clinicians find the device is safe and easy to insert and remove,” said Thompson. “There is minimal training required for those familiar with endoscopy and the procedure can be done consistently in less than 20 minutes.”

ReShape Medical plans to submit a Premarket Approval application to the FDA in the second quarter of 2014 and anticipates a launch in mid-to-late 2015.

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

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