Medtronic Lands HDE Approval for Enterra II System

Wednesday, January 28, 2015

Source: FDA News

Medtronic said Friday that it has received FDA approval under a humanitarian device exemption for the Enterra II System. The device is intended for the treatment of chronic, drug resistant nausea and vomiting associated with gastroparesis when other treatments fail or can’t be tolerated, the devicemaker said.

Gastroparesis, or delayed emptying of the stomach, is a serious and debilitating condition where the stomach muscles work poorly or not at all. The condition is a particular concern to the growing U.S. diabetes population, many of whom suffer from gastroparesis.

Enterra II Systems includes a small neurostimulator, which is implanted under the skin in the lower abdominal region, and two implanted leads that deliver mild electrical pulses to stimulate the stomach’s muscles. The treatment can be customized to each patient via a handheld programmer.

The new system improves on Medtronic Enterra Therapy, which has been available since 2000, by providing greater system flexibility and ease of use for the physician, the company said. Enterra II also features improved software and battery-life monitoring, and a customized tool that simplifies implantation, the devicemaker said.

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