ReShape Medical® Unveils US Pivotal Trial Results for Non-Surgical Weight Loss Procedure Featured in Top 10 Paper at ObesityWeek 2014
Posted on November 4, 2014
Results validate ReShape™ Procedure as a potential new treatment option for patients with a BMI of 30-40, for whom surgery is not an option and diet and exercise alone have failed
BOSTON & SAN CLEMENTE, Calif., November 4, 2014 (Booth #721) – ReShape Medical today announced the results from its REDUCE US pivotal trial at ObesityWeek 2014, currently taking place in Boston. The results, to be presented during today’s plenary session, demonstrate that patients who underwent the ReShape™ Non-Surgical Weight Loss 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. The REDUCE Pivotal Trial of the ReShape Non-Surgical Weight Loss Procedure is the first prospective randomized pivotal trial of a device to treat obesity to meet its primary efficacy endpoints.
“Bariatric surgeons see first-hand the struggles our patients face when surgery is not an option and diet and exercise alone have failed,” said Jaime Ponce, MD, FACS, Principal Investigator in the REDUCE trial and Medical Director, Bariatric Surgery Program at Hamilton Medical Center, Dalton, Georgia. “The ReShape Procedure’s ability to deliver clinically significant, safe weight loss and strong patient satisfaction shows it is well poised to serve as a new treatment option for patients with a BMI of 30-40, helping them achieve their weight loss goals and providing them with weight management skills that can be used in the long-term.”
The pivotal trial data follows positive results unveiled earlier this year from a prospective evaluation of 60 patients in Spain in a commercial setting. Patients undergoing the ReShape Procedure in Spain lost an average of 14.4 ± 7.4kg and achieved an excess weight loss of 41.7 ± 23.4%. The data also showed a favorable safety profile and high patient satisfaction rate—with 84% of patients reporting being satisfied or very satisfied with the procedure.
“The US trial results announced today coupled with the recent international trial further solidify our confidence in the ReShape Procedure’s ability to help many obese patients in the US that currently do not have good non-surgical options,” said Richard Thompson, President and CEO of ReShape Medical. “We are very pleased to present the potential for our new product at ObesityWeek this year.”
Detailed findings from the REDUCE US pivotal 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 Non-Surgical Weight Loss Procedure is designed to help patients lose weight and facilitate healthy behavior change. The ReShape Integrated Dual Balloon is inserted endoscopically during an outpatient procedure and remains in the stomach for six months. The balloons take up space in the stomach and help patients feel full. While the stomach-filling balloons are in place, patients are counseled by health care professionals on nutrition, exercise and behavior modification to help them develop a healthier lifestyle. This program continues for an additional six months after removal of the balloons and helps reinforce new habits for lasting results.
Dr. Jamie Ponce will present The REDUCE Pivotal Trial: A Prospective Randomized Controlled Trial of a Dual Intragastric Balloon for the Treatment of Obesity during Paper Session 1–Top 10 Papers on November 4, 2014 at 11:00 a.m. EST, at the Boston Convention and Exhibition Center Ballroom. Additional data in support of the ReShape Procedure in an international commercial setting has been selected as a Top 15 Poster by ASMBS. Gontrand López-Nava, MD, Director de la Unidad de Tratamientos Endoscópicos de la Obesidad del Hospital Universitario Sanchinarro will present the poster, Prospective Evaluation of Initial and Repeat Use of a Novel Dual Intragastric Balloon, on November 6 at 2:35 p.m. EST, in the Main Scientific Sessions as one of the Top 15 posters.
About ReShape Medical
ReShape Medical is a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss. Driven by a passion to address the worldwide obesity epidemic, the company has developed a non-surgical alternative for obese patients seeking treatment. Additional company information can be found at www.reshapemedical.com. The ReShape device has been available in the European Union since December 2011.
Caution: Investigational device. Limited by Federal (United States) law to investigational use.