Maestro System is designed to control both hunger and fullness by blocking the primary nerve which regulates the digestive system, thus reducing weight.
The approval was granted to Maestro Implant Kit including anterior and posterior leads and a clinician transmit coil, rechargeable neuroregulator and the individual implantable rechargeable neuroregulator component.
TGA also approved two class I applications for the AC battery charger and the programmer cable.
EnteroMedics president and CEO Mark Knudson said the Maestro System address each patient’s path toward weight loss without compromises in safety, lifestyle or anatomy.
"We look forward to complet the review of the balance of the system components and to the opportunity to provide the Australian bariatric care community with a new, safe and sustainable option for addressing the epidemic of obesity in this important market," Knudson said.
