The Reshape™ Integrated Dual Balloon System
ReShape™ is a next generation technology with features that are designed to enhance performance in three important areas. First, two connected balloons have a larger fill volume than a typical single balloon. Second, it is designed for greater comfort by mounting the two balloons on a flexible shaft that allows the device to conform to the natural shape of the stomach. Finally, the ReShape™ Integrated Dual Balloon is the only intragastric balloon that incorporates a feature that is designed to mitigate the potential for migration of a deflated balloon from the stomach into the intestines.
Dr. Lavin explains The ReShape™ Dual Balloon System
The ReShape™ Procedure
The uninflated ReShape™ Dual Balloon is placed in the stomach during an outpatient procedure that typically takes 20 minutes using conscious sedation (light anesthesia). And endoscope is inserted through the mouth into the stomach and the un-inflated dual balloon is advanced over the guide wire, and precisely placed in the stomach where it is inflated with saline. The dual balloon occupies existing space in the stomach for six months, so patients may feel full and satisfied with less food. It does not change or alter the natural anatomy of the stomach in any way. After six months, the patient returns, and the dual balloon is removed during a second outpatient procedure that typically takes 20 minutes. During the time that the balloon is in your stomach, and for the six months after the balloon is removed, you will receive comprehensive counseling and support services that include frequent in-office coaching sessions to encourage new habits and lasting results.
ReShape™ Nutritional Counseling/Coaching
Our nutritionist will meet with you on a monthly basis for one year to guide, direct and educate you. Patients gain access to the ReShape™ Patient Portal, an online support resource that provides tools and information, helps patients track weight loss, diet, and exercise, and has an online community where they can interact with each other.
Am I a Candidate?
ReShape™ is approved for adults with a BMI between 30 and 40 who have a related health condition. Individuals with a BMI of 30-35 may qualify after discussion with your surgeon.
ReSHape™ was evaluated in the REDUCE pivotal trial, the results of which were presented at the 2014 ObesityWeek, the annual meeting of the American Society for Bariatric Surgeons and published in the journal Surgery for Obesity and Related Diseases. In that study, patients that had ReShape™ lost 2.3 times as much weight as a control group that received diet and exercise coaching only. There were also measurable and sustained improvements in comorbidities and strong patient satisfaction with the procedure.
ReShape™ has also shown to provide clinically significant weight loss in EU commercial use. In a study of ReShape™ in Spain, ReShape™ patients on average lost 47% of their excess weight and maintained 98% of their weight loss at one year.
(1) 5-10% Weight Loss. Reference for 5%: Blackburn G. (1995). Effect of degree of weight loss on health benefits. Obesity Research 3: 211S-216S. Reference for 10%: NIH, NHLBI Obesity Education Initiative. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.