EnteroMedics is planning to submit the pre-PMA (Premarket Approval) application for its Maestro Rechargeable System's VBLOC vagal blocking therapy, based on the ReCharge Pivotal Trial, in the second quarter of 2013.
The decision follows the company’s pre-PMA meeting with the US Food and Drug Administration (FDA).
The Maestro Rechargeable System’s VBLOC vagal blocking therapy is indicated to treat obesity.
The FDA has indicated that the company can expect presenting the PMA before a future FDA advisory committee panel, subject to acceptance of the application and validation and detailed review of the submitted data by the FDA.
EnteroMedics president and CEO Mark Knudson said that the company had a very open and productive meeting with the FDA and look forward to submitting its PMA, as anticipated, this quarter.
"We are confident that the Maestro System holds the unique potential to fill a significant gap that currently exists in the treatment options for people with obesity," Knudson added.