EnteroMedics has presented clinical results from two studies of VBLOC vagal blocking therapy, including data from its Empower study in obesity and from its ongoing VBLOC-DM2 Enable (DM2) study in diabetes using the rechargeable (RC) device.
The Maestro System has met the safety goals for all the studies therapy-related serious adverse events reported across the various study populations.
The preliminary findings from the Empower study suggests that vagal blocking therapy may promote safe and effective weight loss as an adjunct to behavioral support, diet and exercise in morbidly obese patients.
The review further suggested that weight loss effects were evident in both the treatment and control arms because the control arm of the trial, which was intended to be inactive, apparently provided a low-intensity blocking signal that introduced VBLOC Therapy in human subjects.
Mark Knudson, president and CEO of EnteroMedics, said: “Results from multiple studies of the Maestro System, which include over 400 implanted subjects, remain encouraging, with signs of clinically meaningful weight loss and control of obesity related co-morbidities as well as a safety profile unmatched among bariatric surgical procedures.
“Patients in the VBLOC-DM2 study, who use the RC Maestro System for approximately 14 hours a day, experience both meaningful weight loss and significant reductions in their HbA1c levels. Further, because the DM2 study uses RC device, it shows promise in resolving patient compliance for those patients that did not use the device for the prescribed amount of time in the Empower trial and earlier studies.
“We look forward to meeting with the FDA during the current quarter to determine the appropriate regulatory path forward for the Maestro System as a treatment for morbid obesity and its related co-morbidities, diabetes and hypertension,” added Mr Knudson.