Enterra for Gastric Electrical Stimulation

Specifications for the Enterra Gastric Neurostimulator, Model 3116

The Enterra System components consist of:

• A small battery-powered neurostimulator, implanted beneath the skin in the lower abdominal region
• Two intramuscular leads implanted in the muscle wall of the stomach and connected to the neurostimulator
• A handheld, external programmer, used by the physician to noninvasively adjust therapy specifically for each patient, assess neurostimulator battery status, and perform troubleshooting

Physical Characteristics
Height	2.2 in. (55 mm)
Length	2.4 in. (60 mm)
Thickness	0.4 in. (10 mm)
Weight	1.5 oz. (42 g)
Volume	1.3 in3 (22 cm3)
Mode (cycling) (default values)	On 0.1 sec/ Off 5.0 sec
Electrode polarity (default values)	0 = Off 1 = Off 2 = Negative 3 = Positive Case = off

 

Programmable Parameters (approximate)
Voltage (peak)	0 to 10.5 V (0.1 V steps)
Pulse Width	60-450 μsec in 30 μsec steps
Rate	49 values from 2.1 to 130 pps (Hz)
Cycle On time	0.1 to 0.9 sec in 0.1 sec steps 1 to 59 sec in 1 sec steps 1 to 29 min in 1 min steps 0.5 to 24 hr. in 0.5 hr. steps
Cycle Off time	0.1 to 0.9 sec in 0.1 sec steps 1 to 59 sec in 1 sec steps 1 to 29 min in 1 min steps 0.5 to 24 hr. in 0.5 hr. steps

How Enterra Works

The Enterra^® Gastric Neurostimulation System uses mild electrical pulses to stimulate the nerves of the antrum. This stimulation may reduce the symptoms of nausea and the number of vomiting episodes related to gastroparesis.¹ Enterra can be turned off or removed if there is no longer a benefit.

The neurostimulator operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation, through the implanted lead system.

A wide range of noninvasively programmable parameters and stimulation modes are available. The neurostimulator provides current parameter information, via telemetry, when used with the clinician programmer.

Enterra may control symptoms but is not a cure for gastroparesis. Often, a combination of therapies is needed to adequately control symptoms. Rate of improvement varies from person to person.

Indications

The Enterra Gastric Neurostimulation System is indicated for the treatment of chronic intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated.

Note: The Medtronic Model 3116 neurostimulator has an insulation coating to prevent undesirable muscle stimulation. The uninsulated side with the etched identification should be positioned away from the muscle.