EnteroMedics (NSDQ:ETRM) won pre-market approval from the FDA today for its Maestro implant, a neurostimulation device designed to treat morbid obesity, after an advisory panel’s mixed recommendation last summer.
The Maestro device uses mild electrical stimulation to periodically block the vagus nerve, which connects the stomach and the esophagus, to help modify physiological cravings and help patients form better eating habits.
The FDA said it approved the device to treat patients age 18 and older with a body mass index of 35 to 45 and at least 1 other obesity-related condition, such as Type II diabetes, who have tried and failed to lose weight. The approval follows a mixed vote last June by the agency’s Gastroenterology & Urology Devices Panel after the Maestro device failed to meet its efficacy endpoint in a clinical trial.
"In considering the benefits and risks of the device in its review of the Maestro rechargeable system, the FDA considered the clinical study and the panel’s recommendations. Additionally, the agency looked at an FDA-sponsored survey relating to patient preferences of obesity devices that showed a group of patients would accept risks associated with this surgically implanted device for the amounts of weight loss expected to be provided by the device," the federal watchdog said today. "As part of the approval, the manufacturer must conduct a 5-year post-approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity-related conditions.”
“Obesity and its related medical conditions are major public health problems," Dr. William Maisel, deputy director for science and chief scientist at the Center for Devices & Radiological Health, said in prepared remarks. "Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”
EnteroMedics claimed the Maestro device as the 1st new medical device to be approved by the FDA for obesity in more than 10 years, saying it plans a limited release later this year.
"The Maestro system fills a significant gap in the currently available treatment options, offering clinically meaningful weight loss without the fear or many of the side effects associated with existing bariatric options," president & CEO Mark Knudson said in prepared remarks.
The St. Paul, Minn.-based company hit a few hurdles on its road to winning its PMA. The FDA asked the company in 2013 to provide more data on device testing and clinical data, including information on user training and post-approval studies. EnteroMedics submitted its FDA application in June 2013, hoping to land indication to treat obesity, metabolic diseases and other gastrointestinal disorders. The Maestro system has been on the European market since winning CE Mark approval in 2011.
