ReShape LifeSciences Announces Real-World Safety and Efficacy Study Results on ReShape Balloon
SAN CLEMENTE, California, March 5, 2018
ReShape Lifesciences Inc., a developer of minimally invasive medical devices to treat obesity and metabolic diseases, announced today that results from a study examining real-world safety and efficacy of the ReShape BalloonTM were published in the February issue of The Journal of Clinical Gastroenterology and Hepatology.
The publication, titled “Real-world Safety and Efficacy of Fluid-Filled Dual Intra-Gastric Balloon for Weight Loss” discusses a retrospective, physician-sponsored study of data collected on 202 adults at two academic centers and five private practices in which all patients paid for the ReShape Balloon procedure and follow-up visits out of pocket. All patients had the ReShape Balloon inserted for weight loss therapy and the Balloon was removed from each patient after six months. Patients also received counselling on lifestyle modifications focused on diet and exercise.
Primary outcomes were percent total body weight loss (%TBWL) and percent excess weight loss (%EWL) at one, three, six, nine and twelve months after the procedure. Mean %TBWL was 11.4% and 14.7% at six and twelve months, respectively. 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL.
“I am incredibly excited to participate in the real-world use of the ReShape Balloon across several sites,” stated Sameer Islam, MD, MBA, Clinical Assistant Professor of Medicine TTUHSC – Department of Internal Medicine. “The results of the study verify the weight loss benefits of the ReShape Balloon, with most patients achieving greater than 10% TBWL at 6 months. I am excited to continue to integrate this technology into my practice.”
Study investigators concluded that the ReShape Balloon is a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at six months.
“We are thrilled to have real-world confirmation of the safety and efficacy of our ReShape Balloon,” stated Dan Gladney, President and Chief Executive Officer of ReShape Lifesciences. “With the recent focus amongst industry practitioners and leaders on real-life outcomes, the desire for investigators to perform the study and the outcomes they found are a powerful validation of this technology as a real option for patients who are battling obesity.”
About ReShape Lifesciences Inc.
ReShape Lifesciences is a medical device company focused on technology to treat obesity and metabolic diseases. The FDA-approved ReShape BalloonTM involves a non-surgical weight loss procedure that uses advanced interconnected balloon technology designed to take up room in the stomach to help people with a 30-40 BMI, and at least one co-morbidity, lose weight.