An FDA advisory panel has given the agency something to chew on with its guarded, rather lukewarm nod to EnteroMedics, Inc’s neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders. The Gastroenterology and Urology Devices Panel voted 8 to 1 “in favour” that Maestro nerve-stimulation implant is safe when used as designed. However when it came to efficacy the vote was split with 4 in favour and 5 against. Despite that, somehow the final vote saw the panel decide that the relative benefits outweighed the relative risk, returning a vote of 6 in favour, 2 against and 1 abstention.
Device company EnteroMedics specialises in the development and commercialization of its neuroscience-based technology to treat obesity and metabolic diseases. VBLOC® vagal blocking therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses, which helps control both hunger and fullness. The company claims that VBLOC allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort.
In the most recent clinical trial, the ReCharge Study, VBLOC Therapy treated patients demonstrated a clinically meaningful and statistically significant excess weight loss (EWL) at 12 months of 24.4%, sustained out to 18 months. The majority (52.5%) lost 20% or more of their excess weight and nearly one-third of VBLOC Therapy treated patients lost 30% or more. The 24.4% average EWL far exceeds the 10% to 15% thresholds at which patients experience substantial positive health effects. Statistically significant improvements were observed in the VBLOC Therapy treatment group in total cholesterol, LDL, triglycerides, systolic and diastolic blood pressure, heart rate and waist circumference.
So what’s not to like? This is pure speculation, but we suspect the panel, even if it had doubts about efficacy, was convinced enough of the safety of the therapy to let it through. Now it’s over to the FDA which, while not bound by the panel’s recommendation, is usually heavily influenced by it so Enteromedics will be waiting with bated breath for a decision on approval of the PMA later this year. And that, by the way, would be a significant milestone: If approved, the Maestro Rechargeable System will be the first new medical device approved for obesity by the FDA in over ten years.
“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,” said Greg Lea, Senior Vice President, Chief Operating Officer and Chief Financial Officer of EnteroMedics, “Where existing options are clearly failing to address the growing epidemic of obesity, we believe VBLOC 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. We thank the Committee members for their insights and look forward to a continued, productive dialogue with the FDA.”
Source: EnteroMedics, Inc.