A device implant developed to help obese adults control their appetite has moved forward in the process of getting approval from the United States Food and Drug Administration (FDA), the EnteroMedics Inc. announced Tuesday.
EnteroMedics says in a statement that the device, dubbed as Maestro Rechargeable System (MRS), received from FDA’s Advisory Gastroenterology and Urology Devices Panel (GUDP) an “in favor” vote of eight as opposed to one that the implant is safe for patients when it is used as designed and an “against” vote of four as opposed to five in terms of “a reasonable assurance of efficacy.” On whether its relative benefits outweighs its relative risk, the final vote of “in favor” was six as opposed to two, with one abstention.
The device on review stimulates the stomach nerves electrically. It is designed for obese adults who failed to get rid of excess pounds through traditional ways but can't have or want to have weight-loss surgery.
"Obesity is the most under-treated disease in this country, despite its increasingly well-understood role in co-morbid conditions ranging from hypertension and diabetes to cancer," says Greg Lea, senior vice president, chief financial officer and chief operating officer of the EnteroMedics, a developer of medical devices that apply neuroblocking technology in the treatment of obesity, gastrointestinal disorders and metabolic diseases.
The company expects that a final decision on the device’s Premarket Approval (PMA) will come out later in 2014. The final decision of the GUDP is usually followed by the FDA, although it is not compelled to do so. The MRS, if approved by the FDA, will be the very first new medical implant for obesity in more than 10 years.
"…we believe VBLOC Therapy [Vagal Blocking Therapy] may offer a unique approach to treating obesity, a choice that fills this void by offering a safe, reversible option that does not alter the anatomy, allowing patients to take a positive path towards improving their overall health,” explains Lea.
Based on the statistics from the U.S. Centers for Disease Control and Prevention, over one-third of adults in the U.S. are obese. Obesity increases the risk of more serious health conditions such as diabetes, cancer, depression and heart disease, research says.
Associate professor Martin Binks of nutritional sciences at the Texas Tech University says that the society "have very few tools at our disposal compared with other chronic diseases.”
"We certainly are encouraged by the FDA's recent willingness to review treatments for obesity," adds Binks, who is to testify before the GUDP on behalf of Obesity Society.
The company says patients who went through the said therapy showed a significant loss of excess weight of 24.4 percent at 12 months. Majority of them, or about 52.5 percent, lost at least 20 percent of their extra weight, while close to one-third lost 30 percent or more.
Significant improvements in the total cholesterol, heart rate, triglycerides, waist circumference, diastolic and systolic blood pressure and LDL were also observed during the therapy treatment.
