EnteroMedics (NSDQ:ETRM) said today that the first commercial patient has been implanted with its Maestro neurostimulation anti-obesity implant.
The surgery took place at Tufts Medical Center in Boston May 13, performed by Dr. Sajani Shah, EnteroMedics said.
The Maestro is designed to use what EnteroMedics calls "vBloc therapy" in which electrical pulses are used to block intra-abdominal vagus nerve signaling between the brain and stomach using a pacemaker-like device, the company said.
“Until recently, there was a great unmet need for new, alternative treatment options for obese patients for whom behavior modification, pharmaceutical options or anatomy altering/restricting surgical procedures either did not work, or were not viable options. Earlier this year, the FDA approved a first-of-its-kind treatment that offers a neuroscience-based approach to the treatment of obesity, differentiating it from traditional weight loss surgical options. As a member of the team that brought this new device through the clinical trial phase, I am pleased to have performed the first U.S. commercial implant of vBloc therapy. At Tufts Medical Center, we are committed to staying on the leading edge of new technologies that may benefit our patients,” Shah said in a press release.
St. Paul Minn.-based EnteroMedics won FDA approval for the device in January 2015, following a mixed vote last June after the device failed to meet its efficacy endpoint in a clinical trial.
“The 1st commercial implant of vBloc therapy marks another significant milestone for EnteroMedics and the millions of individuals with obesity who may be seeking different ways of achieving safe, effective weight loss. We are pleased with the response to vBloc therapy from patients and physicians alike and remain focused on the continued development of partnerships with bariatric centers of excellence and on driving reimbursement for vBloc therapy to ensure its widespread availability in the United States,” CEO Mark Knudson said in prepared remarks.