"The ability to sustain meaningful weight loss is vital when considering a viable long term solution for treating obesity and its related comorbidities," said
Durable Weight Loss
The ReCharge Pivotal Trial is a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial of vBloc Neurometabolic Therapy in 239 patients with obesity. At 24 months, 76% percent of the randomized vBloc participants (n=123) remained in the trial. The mean excess weight loss (EWL) among vBloc participants who presented for their 24-month visit was 21%, with a mean percent total weight loss (TWL) of 8%. Of the 24 Sham control patients who had not yet crossed over to vBloc at 24 months, the EWL and TWL was 4% and 1%, respectively. The authors noted that comparative randomized controlled trials for conventional bariatric procedures demonstrated only 6% TWL for laparoscopic adjustable gastric banding (LAGB) at the same time point. Patients' quality of life improvements, as measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, were shown to be durable with a sustained increase of 20 units from their preoperative level, and the Three-Factor Eating Questionnaire (TFEQ) showed that patients continued to have a 50% reduction in hunger.
Among participants with pre-diabetes or metabolic syndrome at baseline, approximately 50% demonstrated resolution of pre-diabetes or metabolic syndrome at 24 months compared to baseline. Among the subset of participants with abnormal cardiovascular or metabolic conditions at baseline, statistically significant improvements were observed in mean low density lipoprotein (LDL) cholesterol (−16 mg/dL) and high density lipoprotein (HDL) cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg), and hemoglobin A1c (HbA1c) (−0.3 %).
The authors noted that the safety profile of vBloc Therapy remained favorable at 24 months compared to complications observed with conventional bariatric procedures such as sleeve gastrectomy and gastric bypass. Ninety-four percent of all adverse events were reported as mild or moderate in severity, and 83% of events had resolved by 24 months. Three serious adverse events were reported and adjudicated by the independent clinical events committee to be unrelated to vBloc therapy.
"Without altering the anatomy of the gastrointestinal system, vBloc's potential for serious adverse events is minimal, and the ReCharge study helps solidify this important fact. vBloc's safety profile may serve as a future benchmark for obesity treatment options," said
"These findings are crucial as we continue to advance towards our goals of both expanding the reach of this proven technology, as well as obtaining reimbursement for patients in need," says
About EnteroMedics Inc.
Information about the Maestro® Rechargeable System and vBloc® Neurometabolic Therapy
You should not have an implanted Maestro Rechargeable System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the Maestro Rechargeable System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.
Talk with your doctor about the full risks and benefits of vBloc Therapy and the Maestro Rechargeable System. For additional prescribing information, please visit www.enteromedics.com.
If you are interested in learning more about vBloc Neurometabolic Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements about
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/enteromedics-announces-publication-of-24-month-recharge-clinical-study-data-in-obesity-surgery-300313199.html
News Provided by Acquire Media