Inspire

Primary DI

10855728005762

Brand

Inspire

Company

Inspire Medical Systems, Inc.

Model

900-007-010

Catalog number

3028

Device description

The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

Published

2020-10-15

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

MR Conditional

Rx

true

Sterile

true

Single use

true