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EnteroMedics Receives First Approval for the Active Implantable Medical Device Components of the Maestro System From Australian Therapeutic Goods Administration


EnteroMedics Inc. (NASDAQ: ETRM) today announced approval by the Australian Therapeutic Goods Administration of the critical active implantable medical device 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.

Posted-In: News FDA


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