EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic disease and other gastrointestinal disorders, today announced approval by the Australian Therapeutic Goods Administration (TGA) of the critical active implantable medical device (AIMD) components of the Maestro System, a first-in-class, safe, effective and sustainable weight loss treatment which is designed to control both hunger and fullness by blocking the primary nerve which regulates the digestive system.
TGA approval was granted for the Maestro Implant Kit, which is comprised of a rechargeable neuroregulator, anterior and posterior leads and a clinician transmit coil, as well as the individual implantable rechargeable neuroregulator component, both of which were AIMD applications. In addition, TGA approved the two class I applications for the AC battery charger and the programmer cable. The TGA continues review of the balance of the individual class III components, which include the mobile charger, multiple versions of the patient transmit coil and the clinician programmer.
"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 Mark B. Knudson, Ph.D., 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 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."Copyright 2011 The Associated Press.