Chapter 6: Additional Information
Page 88
Chapter 6: Additional information
Clinical Studies
Introduction
Argus 2s Changes and Clinical Evaluation
The Argus 2s system has overall the same
functionality as the approved Argus II system with
some upgrades to the glasses and VPU.
However, the implant part of the system is
identical to the approved Argus II implant.
The glasses were re-designed for better fit and
comfort and a feature was added to improve the
adjustment of the antenna to help improve the RF
link between the implant antenna and the glasses
antenna. A new digital camera was also added to
the glasses to help improve performance in low
light conditions.
The VPU was also re-designed. It is smaller and
lighter weight. A new loop mechanism allows the
VPU to be held in a variety of ways using the VPU
Strap. There is also a new battery design that
makes inserting and removing the battery easier.
The upgrades were validated during a clinical
evaluation study to ensure that the Argus 2s
