St. Paul, Minn.-based EnteroMedics calls the Maestro therapy “vBloc,” as it’s designed to stimulate the vagus nerve to control feelings of hunger and satiety.
The therapy was used as an adjunctive rescue treatment in 2 obese patients, a 64-year-old male and a 55-year-old female, who both lost and maintained significant weight loss after sleeve gastrectomies. The patients did not move beyond Class II obesity or show enough abatement of diabetes symptoms and elected to have the Maestro device implanted rather than undergo duodenal switch or gastric bypass procedures, the company said.
Both surgeries, performed at the VA North Texas Health Care System by Dr. Sachin Kukreja, were performed without incident and the patients are recovering well, EnteroMedics said.
“Patients with obesity who have co-morbid diabetes need to understand the urgent need to achieve weight loss to improve their health,” Kukreja said in prepared remarks. “For some patients, despite having bariatric surgery like a gastric sleeve, additional measures may be necessary to overcome the many signals driving their obesity. vBloc therapy helps to target the neurologic drive that may provide a barrier to optimum weight loss. As the first VA facility to perform a vBloc procedure in 2015, we have witnessed 1st-hand the unique and innovative approach that vBloc provides to patients struggling with obesity. vBloc therapy is highly adaptable and can be individualized for each patient to control hunger and provide a feeling of fullness when they most need it. This results in safe, durable weight loss while helping to control co-morbidities. vBloc is also minimally invasive and now, as an adjunctive rescue therapy, will provide an attractive treatment option for patients fighting their obesity after undergoing more invasive surgical treatments.”
“There are more than 100,000 gastrectomies performed in the U.S. each year. Up to ⅓ of these patients will not achieve or maintain meaningful weight loss after 5 years. The VA is a pioneer in bariatric surgeries, offering veterans an important means of addressing their obesity and its co-morbidities. Our experiences at the VA and other centers across the U.S. will provide an important foundation for our continued commercial progress and expanded use of vBloc Therapy. Obesity is a chronic disease that often requires chronic treatment; vBloc used as an adjunctive therapy may play an important role for many,” added president & CEO Dan Gladney.
“This first-of-its-kind procedure provides critical insight into patient decision-making in individuals who have already opted to undergo, yet failed, an anatomy-altering or lifestyle-restricting bariatric procedure,” VP & chief medical officer Dr. Scott Shikora said in a press release. “Many patients want a solution to their obesity that does not involve the sacrifices associated with more invasive procedures. Because vBloc therapy offers this, it holds the potential to drive greater adoption of bariatric weight loss procedures, improving patient health and reducing the costs associated with treating obesity and its co-morbidities.”
The FDA granted pre-market approval for the Maestro device in January 2015. Last month EnteroMedics closed a convertible debt tranche worth $6 million and inked a deal with a distributor for the U.S. Veterans Affairs Dept. for the Maestro device.