In a pre-PMA application meeting with FDA last week, the federal watchdog agency said EnteroMedics can anticipate presenting the Maestro PMA (if the agency accepts the PMA application) before a future FDA advisory committee panel, the St. Paul, Minn.-based company stated in a press release.
"We had a very open and productive meeting with the FDA and look forward to submitting our PMA, as anticipated, this quarter," EnteroMedics president & CEO Dr. Mark Knudson said in a press statement. "We are confident that the Maestro system holds the unique potential to fill a significant gap that currently exists in the treatment options for people with obesity."
Maestro delivers VBLOC therapy through 2 laparoscopically implanted leads that intermittently block the vagus nerves using high-frequency, low-energy electrical impulses, according to the medical device company. VBLOC therapy targets the vagus nerves that control digestive functions and affect the perception of hunger and fullness.
The therapy is powered by an internal, rechargeable battery, which is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week.
Maestro has a CE Mark and has been listed on the Australian Register of Therapeutic Goods, EnteroMedics noted.
The ReCharge pivotal trial is a double-blind, sham-controlled, multi-center pivotal clinical trial in 239 randomized patients (233 implanted) at 10 sites that tests the safety and effectiveness of VBLOC vagal blocking therapy using EnteroMedics’ second generation Maestro rechargeable system.
All patients in the trial received an implanted device and were randomized 2:1 in treatment or control groups. The control group received a non-functional device during the trial period.
Maestro demonstrated statistically significant and clinically meaningful excess weight loss (EWL) and an excellent safety profile in the ReCharge trial, EnteroMedics announced in February. This included an average EWL of approximately 25% for VBLOC therapy-treated patients, with over 50% of those patients achieving at least a 20% EWL.
While ReCharge demonstrated pre-specified safety measures, with both a positive benefit-to-risk equation and a medically meaningful and clinically significant effect over the control group, the results did not meet the study’s predefined efficacy measures, EnteroMedics noted.