Second Sight Medical A01 Argus II Retinal Prosthesis System User Manual Doctors Users Manual

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Argus® II
Retinal Prosthesis System
Product Insert
Rx Only: Federal law restricts this device to sale
by or on the order of a physician.
HUMANITARIAN DEVICE: Authorized by Federal
(U.S.) law to provide electrical stimulation of the
retina to induce visual perception in blind patients
with severe to profound retinitis pigmentosa and
bare light or no light perception in both eyes. The
effectiveness of this device for this use has not
been demonstrated.
900007-003 Rev D
Argus® II
Retinal Prosthesis System
Product Insert
Second Sight Medical Products, Inc.
12744 San Fernando Rd., Building 3
Sylmar, CA 91342, USA
Phone: +1 818 833 5000
Fax: +1 818 833 5067
E-mail: service@2-sight.com
Visit us at www.2-sight.com
Copyright © 2013
Second Sight Medical Products, Inc.
Argus, Second Sight and the Second Sight Logo
are registered trademarks of
Second Sight Medical Products, Inc.
TABLE OF CONTENTS
DEVICE DESCRIPTION ...................................... 1
INDICATIONS FOR USE ..................................... 1
CONTRAINDICATIONS....................................... 1
WARNINGS ......................................................... 2
PRECAUTIONS ................................................... 3
CLINICAL CONSIDERATIONS ........................... 9
REPORTED ADVERSE EVENTS ...................... 10
POTENTIAL ADVERSE EVENTS ..................... 14
PROBABLE BENEFIT ....................................... 14
MRI INFORMATION .......................................... 18
ELECTROMAGNETIC ENVIRONMENTS ......... 22
WIRELESS INFORMATION .............................. 26
STORAGE AND USE ........................................ 28
HANDLING ........................................................ 28
SHELF LIFE ....................................................... 28
STERILIZATION ................................................ 28
DIRECTIONS FOR USE & REQUIRED
TRAINING .......................................................... 28
INTELLECTUAL PROPERTY INFORMATION . 29
DEVICE DESCRIPTION
The Argus II Retinal Prosthesis System (hereinafter referred to as
“Argus II System”) consists of implanted and external components.
The implant is an epiretinal prosthesis that includes a receiver,
electronics, and an electrode array that are surgically implanted in
and around the eye. The array has 60 electrodes arranged in a
rectangular grid, of which 55 are enabled. It is attached to the
retina over the macula with a retinal tack. The external equipment
includes glasses, a video processing unit (VPU) and a cable. The
glasses include a miniature video camera, which captures video
images, and a coil that transmits data and stimulation commands to
the implant. The VPU converts the video images into stimulation
commands and is body-worn. The cable connects the glasses to
the VPU. The Argus II System operates by converting video
images into electrical energy that activates retinal cells, delivering
the signal through the optic nerve to the brain where it is perceived
as light.
The Argus II Clinician Fitting System (CFS) and
Psychophysical Test System (PTS) are used in the clinic to test and
program the Argus II Implant and External Equipment.
INDICATIONS FOR USE
The Argus II Retinal Prosthesis System is intended to provide
electrical stimulation of the retina to induce visual perception in
blind patients. It is indicated for use in patients with severe to
profound retinitis pigmentosa who meet the following criteria:
•
•
•
•
•
Adults, age 25 years or older.
Bare light or no light perception in both eyes. (If the patient
has no residual light perception, then evidence of intact
inner layer retina function must be confirmed.)
Previous history of useful form vision.
Aphakic or pseudophakic. (If the patient is phakic prior to
implant, the natural lens will be removed during the
implant procedure.)
Patients who are willing and able to receive the
recommended post-implant clinical follow-up, device
fitting, and visual rehabilitation.
The Argus II implant is intended to be implanted in a single eye,
typically the worse-seeing eye.
CONTRAINDICATIONS
•
Ocular diseases or conditions that could prevent the Argus
II System from working (e.g. optic nerve disease, central
retinal artery or vein occlusion, history of retinal
detachment, trauma, severe strabismus, etc.).
•
•
•
•
•
•
Ocular structures or conditions that could prevent the
successful implantation of the Argus II Implant or
adequate healing from surgery (e.g. extremely thin
conjunctiva, axial length <20.5 mm or >26 mm, corneal
ulcers, etc.).
Ocular diseases or conditions (other than cataracts) that
prevent adequate visualization of the inner structures of
the eye (e.g. corneal opacity, etc.).
Inability to tolerate general anesthesia or the
recommended antibiotic and steroid regimen associated
with the implantation surgery.
Metallic or active implantable device(s) (e.g. cochlear
implant) in the head.
Any disease or condition (e.g. significant cognitive decline,
etc.) that prevents understanding or communication of
informed consent, fitting of the Argus II System, or postoperative follow-up.
A pre-operative psychological
evaluation may be recommended to confirm the patient is
not contraindicated based on this criterion.
Predisposition to eye rubbing.
WARNINGS
•
•
•
•
•
Failure to follow the recommended surgical procedure
for implanting the Argus II Implant may increase the risk of
adverse events and damage to the implant.
Individuals implanted with an Argus II Implant should
not undergo short wave or microwave diathermy.
High currents induced in the implant electrodes can cause
tissue damage or serious injury. Diathermy may also
cause permanent damage to the implant.
Individuals implanted with an Argus II Implant should
not undergo electroconvulsive therapy (ECT) as ECT
may cause tissue damage or permanent damage to the
implant.
If lithotripsy or high output ultrasound must be used,
do not focus the treatment beam near the Argus II Implant.
Exposure of the Argus II Implant to these therapies may
harm the patient or damage the implant.
The Argus II Implant has been classified as an MR
Conditional device. Individuals with an Argus II Implant
may undergo a magnetic resonance imaging (MRI)
procedure ONLY if it is performed using a 1.5 or 3.0 Tesla
MRI System and ONLY following the MRI Instructions
provided later in this insert. Individuals with an Argus II
Implant should not enter a room housing an MRI System
that has a rating other than 1.5 or 3.0 Tesla, even if the
Argus II System is not being used.
The external
equipment (i.e. VPU and glasses) should remain outside
•
•
the MR system room, as severe harm to people in the
MR system room could occur. If any pain is experienced
during the MRI procedure the patient should be instructed
to notify the technician immediately.
The Argus II System may interfere with the operation or
accuracy of medical monitoring, diagnostic or life
support equipment. Do not use the Argus II System
within 3 feet (0.9 meters) of this type of equipment. If
interference occurs, turn off the Argus II VPU or extend
the distance between yourself and the affected equipment.
Do not use monopolar electrosurgical equipment in
individuals with an Argus II Implant. Monopolar
electrosurgical equipment may cause damage to the
implant or to tissue surrounding the implant.
PRECAUTIONS
•
•
•
•
•
•
In the event of any undesirable sensation when using
the Argus II System (for example, pain), immediately halt
operation of the system by removing the Argus II Glasses
or turning off the Argus II VPU.
At any time after implantation, Argus II patients have a risk
of conjunctival complications which, if left untreated, may
result in conjunctival erosion which could lead to
endophthalmitis. Argus II recipients should be vigilant in
reporting any new symptoms of foreign body sensations,
tearing and/or pain promptly to their eye care professional.
Long-term professional monitoring for late conjunctival
issues is necessary.
The long-term effects of chronic electrical stimulation
are unknown. Such effects may include deterioration of
the retina or optic nerve. These effects may lead to
deterioration of residual native vision and/or visual
response to the Argus II System and could preclude
subsequent replacement of the Argus II Implant with
another retinal implant.
Individuals with an Argus II Implant should only use a
VPU that has been specifically programmed for them
by their clinician or Second Sight personnel. Use of a
different VPU may be ineffective in providing visual
information and may cause physical discomfort from
overstimulation.
To avoid unsafe stimulation, do not use a VPU
configured for Operating Room use for anything other
than pre-implantation testing, testing during implantation,
or initial fitting testing.
Individuals with an Argus II Implant should avoid physical
impact or extreme direct pressure to the eye as this
•
•
•
may result in eye trauma, movement or damage to the
Argus II Implant. If this occurs, consult your physician.
Individuals with an Argus II Implant should avoid eye
rubbing as this may dislodge the implant or cause eye
irritation.
Individuals with an Argus II Implant should continue to use
their other mobility aids (e.g. canes, dogs, etc.) at all
times.
Use of the Argus II System during pregnancy and
nursing has not been evaluated.
Precautions Regarding Other Medical Procedures
General Information (applicable to all procedures)
•
Individuals needing to undergo any of the procedures
listed below, should inform his or her doctor about the
existence of a retinal prosthesis in the eye. The doctor
should contact Second Sight at 1-818-833-5060 for more
information.
•
Before having any medical or test procedure that
involves the use of other medical equipment,
individuals with an Argus II Implant should remove the
Argus II Glasses and VPU.
•
Once the procedure is complete, that individual should
have the Argus II Implant tested as soon as possible to
make sure it is still functioning properly. Damage to the
implant may not be immediately detectable.
Information about Specific Procedures
•
•
•
•
Magnetic Resonance Imaging (MRI) – Refer to the
Warnings section above and the MRI Information section
below for more information about MRI.
The use of laser, phacoemulsification, or fragmatome
may damage the Argus II Implant. If these procedures
must be used in an implanted eye, do not direct the laser
beam at the implant. Extra caution should be used when
performing these procedures intraocularly as visualization
of the implant may be obscured.
The use of bipolar electrosurgical equipment may
damage the Argus II Implant. Use caution when using this
equipment near the implant.
CT Scans or Diagnostic Ultrasound may be performed
in individuals with an Argus II Implant. However, if a scan
or ultrasound is performed in the region where the Argus II
•
•
Implant is located, the implant may create an image
artifact making the scan unreadable in this region.
Use of defibrillators or therapeutic ionizing radiation to
the head may permanently damage the Argus II Implant.
However, this should not preclude or change the way in
which these treatments are delivered. The Argus II
Implant should be tested by a qualified clinician or Second
Sight personnel as soon as possible following the
procedure or defibrillator activation to confirm that it is still
functioning properly. Damage to the implant may not be
immediately detectable.
The effects of cobalt treatment and linear acceleration
techniques on the implant are unknown.
Electromagnetic Interference (EMI)
Electromagnetic interference is a field of energy (electrical,
magnetic, or both) created by equipment found in public
environments that may be strong enough to interfere with the
normal operation of the Argus II System. The Argus II System
meets international standards for electromagnetic compatibility and
is designed to continue to operate in a “safe mode” in the presence
of any electromagnetic interference which would normally be
encountered during every day use of the Argus II System. It is
important to note, however, that in certain circumstances,
electromagnetic interference could cause the following:
•
•
•
•
Serious injury. Exposure of the implant to EMI may result
in the implant heating and damaging nearby retinal tissue.
See “Warnings” on page 2.
Damage to the Argus II implant. Damage to the implant
may require replacement, or result in loss of, or
irreversible change in the performance of the Argus II
System. See “Warnings” on page 2.
Unexpected Turning off of the Argus II VPU. EMI may
cause the VPU to turn off unexpectedly.
Interruption of Stimulation. EMI may cause a
momentary interruption of stimulation.
Argus II System users should be advised that upon entering an
environment which maybe causing interference with the Argus II
System, they should move away from the equipment or object
thought to be causing the interference, if possible, turn off the
equipment or object causing the interference, tell the equipment
operator or the doctor what happened and, if they continue to
experience interference or think that the Argus II System is not
working as well as it did before they encountered the interference,
to contact their doctor.
Information to User (FCC Rules)
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not
cause harmful interference, and (2) This device must accept any
interference received, including interference that may cause
undesired operation.
This equipment has been tested and found to comply with the limits
for Class B Digital Device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is
no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to
radio or television reception, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures.
•
•
•
Reorient or relocate the receiving antenna
Increase the separation between the equipment and receiver
Connect the equipment into an outlet on a circuit different
from that to which the receiver is connected
Consult the dealer or an experienced radio/TV technician for
help
•
Any changes or modifications not expressly approved by Second
Sight Medical Products, Inc. could void the user’s authority to
operate the equipment.
Possible Interference with Other Electronic Devices
•
Theft or metal detectors (such as those located in
entrances to public buildings and department stores) and
airport or security screening devices may temporarily
interrupt Argus II stimulation if the Argus II System is used
within 1 yard (0.9 meters) of them. Normal operation will
resume when you move away from these items. When
•
•
•
•
possible, it is best to avoid these devices or turn the VPU
off when passing through these systems. Individuals with
an Argus II Implant should show their ID card to any
attendant in the area who may be able to assist them in
bypassing the devices. If unavoidable, walk through the
scanner and promptly move away from the area. Do not
lean on these scanners or linger in their path.
Electronic Article Surveillance (EAS) systems, EAS
Tag Deactivators, and Radiofrequency identification
(RFID) systems may temporarily interrupt Argus II
stimulation if the Argus II System is used within 3.5 yards
(3.2 meters) of them. Normal operation will resume when
you move away from these items. RFID systems and EAS
systems and tag deactivators send out energy fields that
wirelessly communicate with tags that are attached to
objects such as merchandise, materials and people.
These systems are used for security, theft prevention,
tracking and inventory control and they are usually found
in retail stores, libraries, government buildings,
warehouses and offices. For example, security tags
attached to clothing contain RFID tags.
Electrostatic Discharge (ESD) may interfere with normal
operation or cause damage to the electrical components
of the Argus II System. Common situations that create
static electricity include putting on or removing clothes, or
dragging feet across a carpet or rug when there is less
than 30% relative humidity. Care should be taken to avoid
handling the VPU and glasses when static electricity is
present.
The Argus II System may interfere with the normal
operation of some models of hearing aids. Hearing aids
should be tested prior to implantation, to ensure proper
functioning of both the Argus II System and the hearing
device.
Some home appliances (for example, microwaves ) and
some devices with antennae (for example, cell phones,
and cordless phones) may temporarily interrupt Argus II
stimulation if the Argus II System is being used near them.
The table below lists the distance at which interruption of
stimulation may occur with these systems.
Table 1: Separation Distances
Type of device
Interruption of stimulation
may occur if device is
operated within this distance
of the Argus II System
Another Argus II System
7 inches (17.5 cm)
Cell phone
1 inch (2.5 cm)
Cordless phone
1 inch (2.5 cm)
Bluetooth device
1 inch (2.5 cm)
Microwave oven
1 inch (2.5 cm)
WiFi Access Point
8 inches (20 cm)
Wireless Router
8 inches (20 cm)
Normal operation will resume when you move away from these
items.
•
•
The Argus II System operates using wireless technology
which could interfere with the safe operation of an
airplane. Patients should not turn on the Argus II System
on an airplane.
Commercial electrical equipment (such as arc welders,
induction
furnaces
or
resistance
welders),
communication equipment (such as microwave
transmitters, linear power amplifiers and high-power
amateur transmitters), high voltage lines, power lines or
generators, electric steel furnaces, or large
magnetized speakers may temporarily interrupt Argus II
System function. Normal operation will resume when you
move away from these items.
For additional information on specific environments and
recommended separation distances please see the tables provided
in the Electromagnetic Environments section of this insert.
Air Travel, General Travel and International Use
CAUTION: The Argus II System operates using wireless
technologies that could interfere with the safe operation of an
airplane and should not be turned on or used on an airplane.
When travelling and not using the Argus II System, individuals
should be advised to store the external equipment in the travel
case. International travel may require the use of adapters to be able
to plug the VPU battery charger into an electrical outlet. Individuals
with the Argus II System should be advised to both bring their
patient identification card with them to assist in going through
security systems and to turn off the VPU. If individuals with the
Argus II System are experiencing any medical complications before
traveling, they should be advised to speak with a doctor to
determine if it is safe for them to travel, especially on a plane. They
also may wish to obtain the name of a local ophthalmologist, in the
event of any complications during their travels.
Precautions in
Performance
the
Event
of
Change
in
Device
If there is a notable change in performance with the Argus II
System, the patient should contact his or her clinician for
assistance. A visit to the clinic for troubleshooting, diagnostic tests,
or re-programming may be required.
CLINICAL CONSIDERATIONS
•
•
•
•
•
•
•
The Argus II System is not intended to slow or reverse the
progression of the disease.
The Argus II System provides “artificial” vision; it does not
restore normal vision.
The Argus II Implant is intended to be implanted in a
single eye. In general, the Argus II Implant should be
implanted in the worse-seeing eye. If both eyes have
equivalent residual vision and are equally suitable for
implantation, the patient’s preference for the implanted
eye should be respected.
The Argus II Implant is made specifically for either the left
eye or the right eye. Before opening the Argus II Implant
package, carefully read the label and verify that the
package contains the desired device.
Abnormalities in the typical curvature of the retina (e.g.
staphyloma), especially significant protrusions or
depressions in the area centralis, could affect how well the
Argus II Implant fits against the retina. If the implant does
not fit well against the retina, the patient’s performance
with the device may not be optimal.
It is strongly recommended that a preoperative
psychosocial evaluation be performed to determine a
patient’s level of motivation, expectations of the device,
ability to deal with potentially disappointing results, and the
extent of their social support network.
The patient should have the cognitive and physical ability
to operate the Argus II VPU and glasses.
•
•
•
•
If the patient is severely hearing impaired, prior to
implantation the clinician should test to see if the patient
can hear the VPU’s audible alerts using a hearing aid or
other assistive listening devices. If the patient cannot hear
these audible alerts when aided, the clinician should
confirm that the patient has someone who can assist them
in hearing and understanding these alerts. In addition, the
clinician should be able to adequately communicate with
the patient in order to program the Argus II System.
Based on the spacing of the electrodes, the theoretical
limit of resolution of the Argus II is 2.1 logMAR. However,
in the clinical trial, one subject achieved a resolution better
than this (i.e. 1.8 logMAR), likely due to head scanning.
Each Argus II implant has 60 electrodes, of which 55 are
enabled. Up to 5 of the remaining electrodes may be
functional and could be enabled to replace an electrode if
it fails post-implant.
Patients should live within a distance (or be willing to
temporarily relocate to a distance) that will allow their full
participation in recommended post-operative clinical
follow-up, device fitting and training, and visual
rehabilitation.
REPORTED ADVERSE EVENTS
A total of 30 subjects were implanted with Argus II in a clinical trial
(14 were implanted in the United States and 16 were implanted in
Europe). Follow-up time ranged from 2.6 to 4.8 years (average
was 3.5 years). One subject’s device was explanted at 1.2 years
due to recurrent conjunctival erosion and refractory hypotony.
Definition of Adverse Events
In the study, serious adverse events (SAEs) were medical
occurrences that:
•
•
•
Necessitated medical or surgical intervention to preclude
permanent impairment of a body function or permanent
damage to a body structure; OR
Caused permanent impairment of a body function or
permanent damage to body structure; OR
Required hospitalization or prolonged hospitalization.
Events not meeting the above criteria were considered non-serious.
All device-related or surgery-related events are summarized below.
10
Overview of Safety Experience
Nineteen (19) subjects (63%) experienced no, or only non-serious,
adverse events. These non-serious events were treated routinely
with medication or observation only. An additional 7 subjects
experienced SAEs that resolved with treatment or minor
interventions.
The remaining 4 subjects were distinct from the other subjects in
that they had a higher rate of adverse events due to a cascade of
related events. In total, these 4 subjects accounted for 57% of all
serious adverse events (SAEs) and 24% of all non-serious adverse
events. Refer to Figure 1.
Figure 1: Overview of Safety Experience
(n=30 subjects)
Serious Adverse Events
Nineteen subjects did not have any device- or surgery-related
serious adverse events (SAEs). Eleven subjects experienced a
total of 23 device- or surgery-related SAEs (Refer to Table 2). Ten
of the 23 events were considered to be related to the Argus II
device and the remaining 13 were considered to be related to a
surgical procedure. SAEs were generally treated with a surgical reintervention, with the exception of endophthalmitis, keratitis, and
uveitis which were treated with topical and/or intravitreal antibiotics.
Infective corneal melt was treated with antibiotics, steroids and
cross-linking.
11
Certain trends were observed in SAEs. First, the majority of SAEs
occurred within the first few months post-implant (more than 60%
occurred within the first 6 months and 35% occurred within the first
6 weeks). Second, SAEs tended to be clustered in a few subjects.
Two subjects accounted for almost half of all SAEs (10/23). In
these cases, the main event either required multiple interventions to
treat it or the subject experienced a cascade of inter-related events.
Table 2: Serious Adverse Events
(Device- or Surgery-Related)
Event
# of
Events
% Subjects
(n=30)
10.0%
10.0%
3.3%
3.3%
10.0%
3.3%
3.3%
3.3%
13.3%
10.0%
10.0%
3.3%
3.3%
6.7%
# of Subjects
Conjunctival dehiscence
Conjunctival erosion
Corneal Melt - infective
Corneal Opacity
Fibrotic events:
RD - rhegmatogenous
RD - tractional and serous
Retinal Tear
Hypotony
Intraocular inflammatory
events:
Endophthalmitis - infective
Uveitis
Keratitis - infective
Re-tack
RD = retinal detachment
Non-Serious Adverse Events
Any adverse event that did not meet the definition of an SAE was
considered to be a non-serious adverse event.
These events
normally resolved on their own or were treated with medical
management (i.e. they did not require surgical re-intervention to
treat). There were 140 non-serious device-or surgery-related
adverse events (in 28 subjects), of which 78 were device-related
and the remaining 62 were surgery-related. The following nonserious events were reported (number of events is indicated in
parentheses): ocular pain (17), conjunctival congestion (11),
epiretinal membrane (11), elective revision surgery (7), nonserious hypotony (7), suture irritation (7), choroidal detachment (6),
12
uveitis (6), inflammatory conjunctivitis (5), retinal thickening with
cystoid macular edema (CME) (5), ocular inflammation (4), retinal
thickening with no cystic changes (4), vitreous hemorrhage (4),
headache (3), high intraocular pressure (3), hyphema (3), keratic
precipitates (3), corneal vascularization (2), epiphora (lacrimation)
(2), and foreign body sensation (2). There was one reported case
of each of the following events: 360 circumferential vitreous band
traction, choroidal effusion, conjunctival cyst, conjunctival
dehiscence, conjunctival erosion, corneal abrasion, corneal
dryness, corneal epithelial defect, corneal filaments, corneal fold,
corneal suture broken, decrease in light perception, fibrosis around
the tack, filamentary keratitis, nausea, nystagmus increase, ocular
fibrin, proliferative vitreo-retinopathy, ptosis, serous retinal
detachment, tractional retinal detachment, retinal folds,
retinoschisis, rubeosis, scleral patch displacement, scleritis, subconjunctival eyelashes, and vertigo.
Surgical Re-Interventions
Nine (9) subjects required a surgical re-intervention(s) to treat a
device- or surgery-related adverse event(s). Seven (7) subjects
had elective revision surgery. Refer to Table 3. In cases where it
was necessary to remove all or part of the implant and/or tack (i.e.
1 case of explant and 3 cases where the retinal tack was removed
to reposition the implant during an elective revision surgery), no
adverse sequelae occurred.
Table 3: Surgical Re-Interventions
Re-intervention to
treat an AE:
Conjunctiva repair
Corneal scraping with
EDTA
Device explant
RD repair
Re-tack
Treatment of hypotony
Laser - Retinal tear
Cross linking for corneal
melt
Elective revision surgery
# of
Subjects
# of
Events
% Subjects
(n=30)
28
26.7%
12
16.7%
3.3%
3.3%
6.7%
6.7%
6.7%
6.7%
3.3%
23.3%
RD = retinal detachment
EDTA = Ethylenediaminetetraacetic acid
13
POTENTIAL ADVERSE EVENTS
The following device-related or implant surgery- related adverse
events were not observed during the clinical trial, but could
potentially occur:
•
•
•
•
•
•
•
Facial nerve stimulation, transient electrical shock, skin
burn due to excessive heating of the external equipment,
or retinal tissue damage due to mechanical trauma,
excessive stimulation or excessive heating of the implant.
Failure or damage to the Argus II Implant requiring it to be
explanted.
Fall or bump resulting from use of the Argus II System.
Risks known to be associated with standard vitreo-retinal
surgery, peeling of an epiretinal membrane and use of a
scleral
band:
suprachoroidal
hemorrhage,
intrusion/extrusion of the scleral band, and macular hole.
Risks known to be associated with the removal of the lens
using clear cornea phacoemulsification: cortical drop in
vitreous or vitreous prolapse.
Risks known to be associated with canthotomy: improper
apposition of the eyelids, chronic irritation at the lid
margin.
Risks known to be associated with the use of general
anesthesia, steroids and antibiotics: chest pain, urinary
retention, myocardial infarction, pulmonary embolism,
deep vein thrombosis, respiratory failure, blood loss
requiring transfusion, systemic infection, prolonged
hospitalization, and allergic reaction to anesthesia.
PROBABLE BENEFIT
The Argus II System provided all 30 subjects with benefit as
measured by visual function tests, although this level of benefit was
variable. All 30 subjects were able to see visual percepts when the
Argus II was electrically activated.
On the Square Localization test (i.e. object localization), subjects
were consistently able to perform better with the System ON versus
System OFF over the course of the study. Figure 2 displays the
observed mean accuracy which indicates the subjects’ mean
distance from the center of the target square. Error bars represent
the mean of the standard error.
On the Direction of Motion test, subjects were consistently able to
perform better with the System ON versus System OFF over the
course of the study. Figure 3 displays the observed mean accuracy
which indicates the mean response error between the angle
14
displayed and the subject’s response.
mean of the standard error.
Error bars represent the
On the Grating Visual Acuity test, the most difficult of the 3 tests,
27% of subjects were able to reliably score on the scale (between
1.6 and 2.9 logMAR with a confidence interval within the scale) at
least once with the System ON, while none of the Argus II subjects
were ever able to score on the scale with the System OFF in either
eye. (Table 4)
Figure 2: Square Localization Results
Time (months)
NOTE: Since this test was introduced midway through the study,
the Baseline to 12-month results were only from subjects enrolled
in 2009. Subjects enrolled in the study in 2007 and 2008 first
performed this test at either their 18- or 24-month follow-up visit.
15
Figure 3: Direction of Motion Results
Time (months)
NOTE: Since this test was introduced midway through the study,
the Baseline to 12 month results were only from subjects enrolled in
2009. Subjects enrolled in the study in 2007 and 2008 first
performed this test at either their 18 or 24 month follow-up visit.
Table 4: Grating Visual Acuity
(n=30)
% of Subjects Whose Visual Acuity Improved
to Less Than 2.9 LogMAR*
System ON
27% (n=8)
System OFF
Implanted Eye
0% (n=0)
System OFF
Fellow Eye
0% (n=0)
* Best result at any follow-up visit.
The Argus II System was also able to provide subjects with benefit
as measured by objectively-scored, partially-controlled functional
vision tests. Subjects consistently performed better with the Argus
II System ON vs. OFF on orientation and mobility tests (finding a
door and following a line, Figure 4 and Figure 5, respectively).
16
Figure 4: Door Task Results
Time (months)
Figure 5: Line Task Results
Time (months)
Self-report questionnaires of activities of daily living and quality of
life indicated mild improvement (Massof Activity Inventory) or no
change (VisQOL), respectively.
An assessment of Argus II subjects in and around their home by
independent, certified low vision rehabilitation specialists was also
performed. This assessment, called the Functional Low-vision
17
Observer Rated Assessment (FLORA) was designed to evaluate
how the Argus II System affected subjects’ well-being and
functional vision. It was added to the study in 2010 at which time
subjects’ length of follow-up ranged from 1.4 to 3.7 years postimplant. In no cases did the assessors report that the Argus II
System had a negative impact on subjects. In 77% of cases,
assessors using the FLORA determined that the subject was
receiving (or had received at one time) functional vision and/or wellbeing benefit from the Argus II System. Refer to Table 5.
Table 5: Summary of FLORA Results
(n=26 subjects)
Effect
Number of Subjects
Positive
9 (35%)
Mild Positive
7 (27%)
Prior Positive
4 (15%)
Neutral
6 (23%)
Negative
0 (0%)
Note: 4 subjects did not participate in the FLORA.
Implant Failures
One Argus II Implant experienced an intermittent communication
link beginning at 10 months post-implant which led to a significant
decline in the functionality of the device.
This device eventually failed approximately 4 years post-implant;
however, the device remained implanted.
MRI INFORMATION
The Argus II Implant is MR Conditional according
to the terminology specified in the American
Society for Testing and Materials (ASTM)
International, Designation: F2503-08, Standard
Practice for Marking Medical Devices and Other
Items for Safety in the Magnetic Resonance
Environment. Non-clinical testing demonstrated
that the Argus II Implant meets the MR
Conditional classification.
18
WARNING Do NOT take the Argus II VPU or glasses into the
MR system room. The VPU and glasses are MR
Unsafe. The VPU and glasses were not tested in
the MRI environment and are not permitted to be
worn by the patient in the MR system room.
Severe harm to the patient and/or damage to the
external equipment may occur.
An individual with an Argus II Implant may safely undergo an MRI
procedure under the conditions specified below:
•
•
•
•
Static magnetic field of 1.5 Tesla or 3.0 Tesla
Maximum spatial gradient magnetic field of 720-Gauss/cm or
less
Maximum MR system reported, whole body averaged specific
absorption rate (SAR) of 2-W/kg for 15 minutes of scanning
(i.e. per pulse sequence)
Normal Operating Mode of operation for the MR system
MRI-Related Heating, 1.5-Tesla
In non-clinical testing, the Argus II Implant produced the following
temperature rise during MRI performed for 15-min of scanning (i.e.,
per pulse sequence) in the 1.5-Tesla (1.5-Tesla/64-MHz,
Symphony, Siemens Medical Solutions, Erlangen, Germany) MR
system: Highest temperature change was +0.6˚C.
Therefore, the MRI-related heating for the Argus II Implant at 1.5Tesla using a transmit/receive RF body coil at an MR system
reported whole body averaged SAR of 3.5-W/kg indicated that the
greatest amount of heating that occurred in association with these
specific conditions was equal to or less than +0.6˚C.
MRI-Related Heating, 3-Tesla
In non-clinical testing, the Argus II Implant produced the following
temperature rise during MRI performed for 15-min of scanning (i.e.,
per pulse sequence) in a 3-Tesla (3-Tesla/128-MHz, Excite, HDx,
Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR
system: Highest temperature change was +2.1˚C.
Therefore, the MRI-related heating for the Argus II Implant at 3Tesla using a transmit/receive RF body coil at an MR system
reported whole body averaged SAR of 2.9-W/kg indicated that the
greatest amount of heating that occurred in association with these
specific conditions was equal to or less than +2.1˚C.
19
Artifact Information
MR image quality may be compromised if the area of interest is in
the exact same area or relatively close to the position of the Argus
II Implant. Therefore, optimization of MR imaging parameters to
compensate for the presence of the implant may be necessary.
Table 6: MRI Artifact Information
Pulse
Sequence
Imaging Plane
Maximum Signal
Void size - mm²
T1-SE
Parallel
979
T1-SE
Perpendicular
959
GRE
Parallel
2,242
GRE
Perpendicular
3,381
During the MRI Procedure
The MRI technologist should tell the patient to notify the MRI
system operator if pain or unusual sensation occurs during the MRI
examination. If the patient experiences any pain or unusual
sensation, the MRI procedure should be stopped immediately and
the source of the problem should be investigated.
Device Functionality
In non-clinical MRI tests, the Argus II implant was exposed to eight
different pulse sequences (see Table 7 below) using 1.5-T/64MHz
(Symphony, Siemens Medical Solution, Erlangen, Germany) and
3.0-T/128MHz Excite, HDx, Software 14X.M5, General Electric
Healthcare, Milwaukee, WI) MR systems. The results indicated that
exposing the Argus II implant to these MRI conditions did not
damage or alter the function of the device nor did it have adverse
effects on the device’s functionality. However, it is strongly
recommended that the Argus II Implant be tested by a qualified
clinician or Second Sight personnel as soon as possible following
an MRI procedure to confirm that it is still functioning properly.
20
Table 7: Summary of MR Imaging Pulse Sequences Used
Sequence
Pulse
T1T1-SE T2-SE
Sequence
FSE
T2FSE
GRE. 3D
FGRE.
3D
GRE.
EPI
MTC
TR (msec) 700
3,000 700
5,000 20
3.7
628
3,400
TE (msec) 10
100
12
113
2.7
1.2
10
103
Flip Angle N/A
N/A
N/A
N/A
25
N/A
Field of
30
View (cm)
30
30
30
30
30
10
30
Section
10
Thick (mm)
10
10
10
10
Axial
Axial Volume Volume Axial
Imaging
Plane
Axial Axial
Axial
T1-SE, T1-weighted spin echo; T2-SE, T2-weighted spin echo; T1FSE, T1-weighted fast spin echo; T2-FSE, T2-weighted fast spin
echo; GRE, gradient echo; 3D, three-dimensional; FGRE, fast
gradient echo; MTC, magnetization transfer contrast; EPI, echo
planar imaging; N/A, not applicable; GRE, gradient echo; SE, spin
echo
21
ELECTROMAGNETIC ENVIRONMENTS
The essential performance of the Argus II System is defined as the
following: During start-up, shut-down, and normal operation of the
interfering device, the Argus II System shall not experience:
•
A permanent shutdown and/or reset of programmable
parameters of the VPU. VPU shutdown during exposure to
the interfering device is acceptable but the VPU must
retain the ability to power-up after the interfering device is
removed. Upon restart of the VPU, all programmable
parameters must remain unchanged.
•
Any unintended or unsafe stimulation. Unintended
stimulation is defined as any stimulation that the VPU is
not programmed to instruct the implant to perform. Unsafe
stimulation is defined as any stimulation, intended or
unintended, that exceeds the balance limit of 5% or the
charge limit of 110nC. The charge limit of 110nC is
equivalent to the charge density limit of 0.35mC/cm2 that
has been established for the Argus II System.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Argus II system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Argus II system should assure that
it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
The Argus II system uses RF energy
only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not
Applicable*
The Argus II System is suitable for
use in all establishments, including
domestic establishments and those
directly connected to the public lowvoltage power supply network that
supplies buildings used for domestic
purposes.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not
Applicable*
* Not Applicable – The Argus II System is Battery Powered
22
Guidance and manufacturer’s declaration – electromagnetic immunity
The Argus II system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Argus II system should assure that
it is used in such an environment.
IMMUNITY test
IEC 60601 test
level
Compliance
level
Electromagnetic
environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 6 kV
contact
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
± 8 kV air
± 8 kV air
Electrical fast
transient / burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Not
Applicable
Surge
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not
Applicable
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
Not
Applicable
IEC 61000-4-11
70 % UT
(30 % dip in UT)
for 25 cycles
IEC 61000-4-5
40 % UT
(60 % dip in UT)
for 5 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency
magnetic fields should be
at levels characteristic of a
typical location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
23
Guidance and manufacturer’s declaration – electromagnetic immunity
The Argus II system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Argus II system should assure that
it is used in such an environment.
IMMUNITY
test
IEC 60601
Test Level
Compliance
level
Electromagnetic environment –
guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the Argus
II system, including cables, than the
recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1.17 P
Conducted
RF IEC
61000-4-6
3 Vrms
150 kHz to
80 MHz
Radiated RF 3 V/m
80 MHz to
IEC
2.5 GHz
61000-4-3
3V
d = 1.17 P 80 MHz to 800 MHz
3 V/m
d = 2.33 P 800 MHz to 2.3 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, object and
people.
a Field
strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the Argus II system is used exceeds the applicable RF
compliance level above, the Argus II system should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Argus II System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.
24
Recommended separation distances between portable and mobile RF
communications equipment and the Argus II system
The Argus II system is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Argus II
system can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the Argus II System as recommended below, according to the
maximum output power of the communications equipment.
Separation distance
according to frequency of
transmitter (m)
Rated maximum
output power of
transmitter
(W)
150 kHz to 80
MHz
80 MHz to 800
MHz
800 MHz to
2.5 GHz
d = [ 3.5] PV1
d = [ 3.5] PE1
d = [ 7 ] PE1
0.01
0.0117
0.0117
0.0233
0.1
0.117
0.117
0.233
1.17
1.17
2.33
10
11.7
11.7
23.3
100
117
117
233
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 Hz, the separation distance for the higher frequency
range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects, and
people.
25
WIRELESS INFORMATION
The Argus II Glasses use wireless technology to communicate with
and power the Implant.
Wireless Specifications
Frequency
(to the implant)
3.156 Megahertz (MHz.)
Frequency
(from the implant)
473 – 490 Kilohertz (KHz.)
Bandwidth
(to the implant)
13 Kilohertz (KHz.)
Bandwidth
(from the implant)
20 Kilohertz (KHz.)
Power
(to the implant)
Amplitude modulation (AM)
Less than 1.2 watts
Power
(from the implant)
Frequency shift keying (FSK)
Less than 10 microwatts
Wireless Link
Performance
Wireless link active more than 90% of the time
when the coil is approximately 1 inch (25 mm) or
closer to the implant.
Wireless Security
The wireless system is designed so the implant
will only operate if it is within a very short
distance of the glasses. The Argus II System
uses a proprietary communication protocol to
reduce the likelihood of inadvertent control or
malicious “hacking” of the System.
No
identifiable personal data are transmitted by the
Argus II System.
26
Wireless Specifications
Quality of Service
In order for the Argus II System to operate, the
external system must be in constant
communication
with
the
implant.
This
communication is achieved through a wireless
link between the glasses and the implant. For
the wireless link to function, the glasses coil
must be in close range (0.78 inches or 20 mm)
to the implant. This link does not depend on any
other system to function. To better ensure
proper functioning of the Argus II System, the
glasses should be worn in the same position as
they were when they were fitted in the clinic.
When the wireless link between the glasses and
implant is broken, an alarm will sound and will
continue to sound until the wireless link is
restored. The link may not function in the
presence of large magnetic or radio fields.
27
STORAGE AND USE
Store the Argus II Implant at temperatures between -10° to 55°
Centigrade (14° to 131° Fahrenheit).
Store the Argus II Externals (VPU and glasses) at temperatures
between 0° to 45° C (32° to 113° F). Only operate the Argus II
Externals at temperatures between 0° to 40° C (32° to 104° F).
HANDLING
The Argus II Implant packaging should be handled with care
appropriate to any implantable medical device. Severe impact
could damage the storage pack and rupture the sterile packaging.
The Argus II Externals should also be handled with care to avoid
dropping, crushing, severe impact, and exposure to water.
SHELF LIFE
A “Use Before” date is located on the Argus II Implant packaging.
This date is two years from the date of sterilization.
STERILIZATION
The Argus II Implant and Argus II spare Tacks are supplied sterile
with indicators of sterilization. They are sterilized using ethylene
oxide. Sterile packs should be carefully inspected to confirm that
they have not been compromised. Sterility cannot be guaranteed if
the sterile package is damaged or opened. These devices are for
single-use only; do not re-sterilize or re-use them.
DIRECTIONS FOR USE & REQUIRED TRAINING
The following are the main steps required to use the Argus II
System:
1.
2.
3.
4.
Device Implantation
Post-Operative Clinical Follow-Up
Device Fitting and Training
Vision Rehabilitation
In addition to this product insert, several manuals are provided with
the Argus II System to provide more detailed instructions for use.
A Surgeon Manual, a video describing the surgical procedure and
implantation of the Argus II Implant, and hands-on training are
provided by Second Sight to all surgeons prior to implantation. The
28
Surgeon Manual also provides instructions for how to screen
potential patients for eligibility for the Argus II System and provides
a recommended clinical follow-up schedule. Surgeons must
undergo this training in order to implant the Argus II Implant.
A Device Fitting Manual is provided to all clinical centers and is
included with the Argus II Clinician Fitting System. The Device
Fitting Manual provides instruction on how to use all components of
the Argus II System. Clinicians and/or technicians must be
knowledgeable about state-of-the-art Argus II System fitting
procedures. These personnel must be fully trained and qualified by
Second Sight in the fitting of the Argus II System.
A Patient Manual is provided in print and audio formats to all
patients implanted with the Argus II Implant. The Patient Manual
describes how to use the external equipment of the Argus II System
that is provided to the patient. Argus II System recipients should
receive training on all aspects covered in the Patient Manual prior
to taking the Argus II External Equipment home for everyday use.
A Visual Rehabilitation Guide and hands-on training is provided to
low vision therapists who will provide visual rehabilitation to Argus II
patients post-implant.
For more information, contact Second Sight using the contact
information provided on the front page of this insert.
INTELLECTUAL PROPERTY INFORMATION
Second Sight products (including the Argus II Retinal Prosthesis,
Argus II Glasses, Argus II OR Coil, Argus II Video Processing Unit
and Argus II Clinician Fitting System) are covered by one or more
of the following patents:
United States:
5,109,844, 5,935,155, 5,944,747, 6,165,192, 6,507,758, 6,533,798,
6,718,209, 6,858,220, 6,920,358, 6,949,253, 6,974,533, 7,079,900,
7,097,775, 7,103,416, 7,127,286, 7,133,724, 7,142,909, 7,149,586,
7,181,287, 7,190,051, 7,211,103, 7,224,300, 7,228,181, 7,257,446,
7,263,403, 7,266,413, 7,291,540, 7,314,474, 7,338,522, 7,379,000,
7,480,988, 7,482,957, 7,483,750, 7,483,751, 7,493,169, 7,499,754,
7,527,621, 7,539,544, 7,565,202, 7,565,203, 7,571,004, 7,571,011,
7,574,263, 7,631,424, 7,638,032, 7,645,262, 7,666,523, 7,668,599,
7,676,274, 7,904,164, 7,904,163, 7,904,148, 7894,911, 7,893,909,
7,881,799, 7,877,866, 7,835,798, 7,835,794, 7,818,064, 7,813,796,
7,776,197, 7,818,064, 7,765,009 7,750,076, 7,749,608, 7,738,962,
7,734,352, 7,725,191, 7,709,961, 7,706,893, 7,691,252, 7,887,681,
7,908,010, 7,908,011, 7,912,556, 7,914,842, 7,925,354, 7,926,221,
7,937,153, 7,941,224, 7,957,810, 7,957,811, 7,962,221, 7,989,080,
29
7,991,478, 8,000,000, 8,010,202, 8,010,206, 8,014,868, 8,014,869,
8,014,878, 8,019,428, 8,034,229, 8,036,751, 8,036,752, 8,046,078,
8,060,211, 8,060,216, 8,068,913, 8,078,284, D565,082, D567565,
D599, 313 D600,440
Australia:
2004235629, 2004235627, 2006202503, 2007201542,
2009204164, 776879, 2004205105, 2006202583, 2002252113,
2007201497, 751995, 2003234174, 2003220590, 739523,
2006306658, 2006239178, 2006208146, 2006214142,
2006292220, 2006306660, 2006241404, 2007243163,
2007243164, 2007261384, 2006311850, 2007284422
Europe:
1171188, 1061996, 1061874, 2219728
Japan:
4384363, 3926564, 4411088, 4290566, 3929701
Canada:
2,323,550, 2,323,551
30
Second Sight Medical Products, Inc.
12744 San Fernando Rd., Building 3
Sylmar, CA 91342, United States
Phone: +1 818 833 5000
Fax: +1 818 833 5067
E-mail: service@2-sight.com
Visit us at www.2-sight.com
Date of Issue: JUL-2013

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