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Product review

EnteroMedics reveals FDA Maestro review meeting

Company to meet with FDA Committee in May 2014

EnteroMedics has announced that the FDA’s Office of Device Evaluation has scheduled a meeting of the Center for Devices and Radiologic Health's (CDRH) Advisory Committee on Thursday 29 May 2014, to review the company’s Maestro System delivering VBLOC vagal blocking therapy as a treatment for morbid obesity.

The CDRH Advisory Committee is an independent panel of clinical and scientific experts that helps evaluate medical devices for safety and efficacy and makes recommendations regarding benefit-risk to the FDA.

EnteroMedics' PMA application for VBLOC Therapy, which was accepted for review by the FDA in July 2013, contains data from the company's ReCharge Pivotal Study.

The ReCharge Pivotal Study is a randomized, double-blind, sham-controlled, multi-centre pivotal clinical study in 239 randomized patients (233 implanted) at ten sites testing the effectiveness and safety of VBLOC Therapy utilising EnteroMedics' second generation Maestro System.

All patients in the study received an implanted device and were randomized in a 2:1 allocation to treatment or control groups. The control group received a non-functional device during the study period.

In February 2013, EnteroMedics announced that its ReCharge Study demonstrated a statistically significant and clinically meaningful excess weight loss (EWL) outcome and excellent safety profile. This included an average EWL of approximately 25% for VBLOC Therapy-treated patients, with over 50% of those patients achieving at least a 20% EWL. While the results demonstrated an excellent safety profile that met the pre-specified study measures, with both a positive benefit-risk equation and a medically meaningful and clinically significant effect over the control group, the results did not meet the study's predefined super-superiority efficacy endpoints.

"We are pleased that the FDA has decided to move the PMA application for our innovative technology forward towards possible approval by scheduling an Advisory panel meeting to discuss the Maestro System,” said Dr Mark B Knudson, EnteroMedics' President and Chief Executive Officer.  “We very much look forward to presenting VBLOC Therapy to the panel members as we work to address the significant and widening gap in treatment alternatives for obesity and its associated diseases. We will continue to focus on thoroughly preparing for panel with the goal of delivering on the promise of this new treatment option to the millions of Americans who suffer with obesity."

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.

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

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