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Implantable medical device

EnteroMedics' Maestro System gains Australian approval

Investigative Vagal blocking therapy device one step closer to full release in Australia

EnteroMedics has received approval from the Australian Therapeutic Goods Administration (TGA) for the critical active implantable medical device (AIMD) components of the Maestro System.

TGA approval was granted for the Maestro Implant Kit, which is comprised of a rechargeable neuro-regulator, anterior and posterior leads and a clinician transmit coil, as well as the individual implantable rechargeable neuro-regulator component, both of which were AIMD applications. 

In addition, the TGA approved the two class I applications for the AC battery charger and the programmer cable. The TGA is currently reviewing individual class III components, including the mobile charger, multiple versions of the patient transmit coil and the clinician 

The Maestro RC System delivers VBLOC vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the oesophagus and the stomach. The Maestro RC System is powered by an internal, rechargeable battery. The battery is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week. 

EnteroMedics developed VBLOC vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices. VBLOC Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.

“The implantable AIMD components of the Maestro System are the heart of our system and of EnteroMedics' revolutionary approach to obesity treatment. Their approval by the TGA, therefore, marks a major milestone for EnteroMedics and a significant accomplishment for both our company and our many collaborators in the Australian healthcare community,” said Dr Mark B Knudson, EnteroMedics' President and Chief Executive Officer.

“The Maestro System is the only surgical intervention to individually address each patient's path toward weight loss without compromises in safety, lifestyle or anatomy. We look forward to completion of the review of the balance of the system components and 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.”

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