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Product approval process

EnteroMedics nears Maestro Rechargeable System approval

Company hopes for FDA approval in first half of 2014

EnteroMedics has received a formal response, a standard component of the PMA process, from the FDA with regard to its Premarket Approval Application (PMA) for approval of the Maestro Rechargeable System as a treatment for obesity.

The response contains follow-up questions related to the application pertaining primarily to device testing and clinical data, including training programs for users and a post approval study. The company anticipates responding to the FDA's questions within the coming weeks.

"We are very encouraged by the responsiveness of the FDA and are confident in our ability to address their questions in a timely manner," said Dr Mark B Knudson, EnteroMedics' President and Chief Executive Officer. "We will continue to work closely with the FDA throughout this process. We believe that the Company continues on track for a panel in late fourth quarter of  of the first quarter of 2014 with approval decision in the first half of 2014."

EnteroMedics' proprietary technology, VBLOC vagal blocking therapy, delivered by a pacemaker-like device called the Maestro Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. VBLOC allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort.

EnteroMedics' Maestro Rechargeable System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.

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