The document summarizes the results of a clinical study evaluating the Amigo remote catheter system. 206 patients were enrolled across 13 centers to assess safety and navigation performance. Physicians were able to successfully navigate to target locations 96-99% of the time. No major complications occurred. Physicians found Amigo easy to use after only a few cases, with navigation times decreasing significantly after the third use. Amigo is designed for simple, intuitive control from a remote workstation to perform electrophysiology procedures.

1. Amigo in Clinical Use

2. Amigo in Clinical Use
Catheter Robotics, Inc. • 500 International Drive • Mt. Olive, NJ 07828 • +1 973.691.2000 • www.CatheterRobotics.com
Study Overview
The purpose of this clinical investigation was
to demonstrate the safety and navigation
performance of Amigo. 206 patients were enrolled
at 13 centers and data was collected and evaluated
on safety, efficacy, and the learning curve of Amigo.
Navigation Performance
Using the remote controller, the catheter was
advanced to 8 pre-specified locations in a specific
sequence.
Time to each location, location accuracy and
quality of contact was confirmed by imaging
with specific criteria for electrograms and pacing
thresholds.
A point was considered a success if all required
data was collected.
A total of 1448 locations were mapped.
Navigation Success Rate
Safety Results
Safety was determined by:
• No Major Complications
• No unanticipated Adverse Events
• No Perforations
Physician Evaluation
After each procedure, the physician filled out
a questionnaire related to ease of use of Amigo
and catheter control with Amigo.
• In 92% of first cases, investigators found Amigo
easy to operate
• In 98% of subsequent cases, investigators found
Amigo was easy to operate.
Learning Curve
The average manipulation time required to reach
a location was 45 seconds.
The first proceedure had the longest average
manipulation time but a statistically significant
decrease occurred by the 3rd use.
Physician learning curve was only associated
with proficiency in using Amigo and not with
complications.
Navigation Times
Amigo Technical Specifications
Parameter Success Rate
Efficacy 96%
Efficacy adjusted for missing source data 97%
Efficacy using floroscopic confirmation only 99%
Responder Success (6/8 locations successful) 98%
1.5
1
0.5
0
AverageManipulationTimeperLocation
(Minutes)
1 2 3
Number of Cases
Mean Manipulation Time
All data based on Amigo IDE Clinical Trial (NCT01139814)
82-0100-005Rev1 © Copyright Catheter Robotics, Inc. 2012. All rights reserved.

3. Amigo Remote Catheter System

4. Amigo Technical Specs
Navigation Times
Amigo Remote Catheter System
Amigo is a new generation of robotic catheter
systems. It utilizes a simple design and a familiar
controller. It was developed with three goals in mind:
• Simple to use
• Easy to learn
• Cost effective
Safe, Consistent Performance
• 99% of target locations are reached with Amigo1
• 0% major complication rate1
Effortless Learning
Requiring less than one hour of practice, and no
animal labs, Amigo is designed to be easy to learn.
There are statistically significant decreases in
navigation times after only 3 patients.1
• In 92% of first cases physicians found Amigo
easy to use1
• Similar to a catheter handle, the controller
is intuitive and familiar
Seamless Integration
Amigo was designed to be cost effective. To achieve
this goal, engineers designed Amigo to fit into an
existing EP Laboratory with no additional costs.
• Compatible with existing monitors and
workstations
• No room rebuild
• No proprietary catheters, introducers, or sheaths,
maintaining procedure costs
Amigo Technical Specifications
Dimensions (H x W x D) 40 x 54 x 44 inches
Weight (approximate) 70 lbs
Performance
Linear translation < 12 mm/sec ± 2 mm/sec
Linear resolution < 1.6 mm
Rotation resolution < 1.1 degrees
Rotation maximum rate < 0.42 revs/sec
Articulation resolution 1.0% full scale
Articulation maximum rate 0.48 revs/sec
Facility Power Requirements 120 VAC, 60 Hz, 15 amp, 1Ø
230 VAC, 50 Hz, 15 amp, 1Ø
1.5
1
0.5
0
AverageManipulationTimeperLocation
(Minutes)
1 2 3
Number of Cases
Mean Manipulation Time
82-1012-001Rev1
1 Amigo IDE Clinical Trial (NCT01139814)
Catheter Robotics, Inc. • 500 International Drive • Mt. Olive, NJ 07828 • +1 973.691.2000 • www.CatheterRobotics.com
© Copyright Catheter Robotics, Inc. 2012. All rights reserved.
Amigo Remote Catheter System

5. Disposable Kits
Controller

6. Controller
Intuitive Control
• Natural and easy to learn1
• Built in safety features
• Simple catheter control up to 100 feet away
Simple, Familiar Design
Rotation knob allows for continuous 360°
rotation of the catheter in either direction.
The Motion Light indicates when the catheter
has reached the maximum movement in a
particular direction.
Deflection knob allows for bidirectional control
of the catheter tip.
Insert button advances the catheter
into the heart.
Withdraw button pulls the catheter
back to be withdrawn.
Ready Light indicates when the system’s
infrared beam has been activated.
82-8020-001Rev1
1 Amigo IDE Clinical Trial (NCT01139814)
Catheter Robotics, Inc. • 500 International Drive • Mt. Olive, NJ 07828 • +1 973.691.2000 • www.CatheterRobotics.com
© Copyright Catheter Robotics, Inc. 2012. All rights reserved.

7. Disposable Kit

8. Disposable Kit
The disposable kit is designed to create a sterile interface between Amigo, the catheter and the physician. The nosecone
attaches Amigo to the introducer and the catheter resides within the track, adding stability to the cathete
The drapes cover the sides and top of Amigo to provide a complete sterile interface.
This kit is comprised of a docking station and a spreader. This item is specific to the type of catheter used and can be
ordered in a Boston Scientific Blazer orientation or a Biosense - Webster EZ STEER
TM
orientation. The docking station
provides an interface for the catheter to attach to Amigo and the spreader guides the catheter into the track.
Disposable
Kits
Kit
1:
Track
and
Nosecone
Kit
This
kit
is
provides
the
nosecone
and
track.
The
nosecone
provides
a
sterile
interface
for
Amigo
to
connect
to
the
introducer.
The
track
provides
a
sterile
interface
for
the
catheter.
Kit
2:
Sterile
Cover
Kit
The
pieces
cover
the
sides
and
tops
of
Amigo
and
provide
a
sterile
interface
for
the
whole
system.
Kit
3:
Docking
Station
Kit
This
kit
is
comprised
of
a
docking
station
and
a
spreader.
This
item
is
specific
to
the
type
of
catheter
used
in
the
procedure
and
can
be
ordered
in
a
Boston
Scientific
Blazer
orientation
or
a
Biosense
–
Webster
EZ
STEER
orientation.
This
kit
allows
the
catheter
to
connect
to
Amigo.
le
Kits
ck
and
Nosecone
Kit
provides
the
nosecone
and
track.
The
nosecone
provides
a
sterile
interface
for
Amigo
to
o
the
introducer.
The
track
provides
a
sterile
interface
for
the
catheter.
rile
Cover
Kit
es
cover
the
sides
and
tops
of
Amigo
and
provide
a
sterile
interface
for
the
whole
system.
cking
Station
Kit
comprised
of
a
docking
station
and
a
spreader.
This
item
is
specific
to
the
type
of
catheter
used
ocedure
and
can
be
ordered
in
a
Boston
Scientific
Blazer
orientation
or
a
Biosense
–
Webster
EZ
entation.
This
kit
allows
the
catheter
to
connect
to
Amigo.
sposable
Kits
t
1:
Track
and
Nosecone
Kit
his
kit
is
provides
the
nosecone
and
track.
The
nosecone
provides
a
sterile
interface
for
Amigo
to
onnect
to
the
introducer.
The
track
provides
a
sterile
interface
for
the
catheter.
t
2:
Sterile
Cover
Kit
he
pieces
cover
the
sides
and
tops
of
Amigo
and
provide
a
sterile
interface
for
the
whole
system.
t
3:
Docking
Station
Kit
his
kit
is
comprised
of
a
docking
station
and
a
spreader.
This
item
is
specific
to
the
type
of
catheter
used
the
procedure
and
can
be
ordered
in
a
Boston
Scientific
Blazer
orientation
or
a
Biosense
–
Webster
EZ
EER
orientation.
This
kit
allows
the
catheter
to
connect
to
Amigo.
Disposable
Kits
Kit
1:
Track
and
Nosecone
Kit
This
kit
is
provides
the
nosecone
and
track.
The
nosecone
provides
a
sterile
interface
for
Amigo
to
connect
to
the
introducer.
The
track
provides
a
sterile
interface
for
the
catheter.
Kit
2:
Sterile
Cover
Kit
The
pieces
cover
the
sides
and
tops
of
Amigo
and
provide
a
sterile
interface
for
the
whole
system.
Kit
3:
Docking
Station
Kit
This
kit
is
comprised
of
a
docking
station
and
a
spreader.
This
item
is
specific
to
the
type
of
catheter
used
in
the
procedure
and
can
be
ordered
in
a
Boston
Scientific
Blazer
orientation
or
a
Biosense
–
Webster
EZ
STEER
orientation.
This
kit
allows
the
catheter
to
connect
to
Amigo.
Disposable
Kits
Kit
1:
Track
and
Nosecone
Kit
This
kit
is
provides
the
nosecone
and
track.
The
nose
connect
to
the
introducer.
The
track
provides
a
steril
Kit
2:
Sterile
Cover
Kit
The
pieces
cover
the
sides
and
tops
of
Amigo
and
pro
Kit
3:
Docking
Station
Kit
This
kit
is
comprised
of
a
docking
station
and
a
sprea
in
the
procedure
and
can
be
ordered
in
a
Boston
Scie
STEER
orientation.
This
kit
allows
the
catheter
to
conn
Blazer
Docking
Station
and
Spreader
82-2000-001Rev01
Blazer is a registered trademark of Boston Scientific.
EZ STEER is a trademark of Biosense-Webster.
Catheter Robotics, Inc. • 500 International Drive • Mt. Olive, NJ 07828 • +1 973.691.2000 • www.CatheterRobotics.com
© Copyright Catheter Robotics, Inc. 2012. All rights reserved.
Disposable
Kits
Kit
1:
Track
and
Nosecone
Kit
This
kit
is
provides
the
nosecone
and
track.
The
nosecone
provides
a
sterile
interface
for
Amigo
to
connect
to
the
introducer.
The
track
provides
a
sterile
interface
for
the
catheter.
Kit
2:
Sterile
Cover
Kit
The
pieces
cover
the
sides
and
tops
of
Amigo
and
provide
a
sterile
interface
for
the
whole
system.
Kit
3:
Docking
Station
Kit
This
kit
is
comprised
of
a
docking
station
and
a
spreader.
This
item
is
specific
to
the
type
of
catheter
used
in
the
procedure
and
can
be
ordered
in
a
Boston
Scientific
Blazer
orientation
or
a
Biosense
–
Webster
EZ
STEER
orientation.
This
kit
allows
the
catheter
to
connect
to
Amigo.
Blazer
Docking
Station
and
Spreader
EZ
STEER
Docking
Station
and
Spreader
Disposable
Kits
it
1:
Track
and
Nosecone
Kit
his
kit
is
provides
the
nosecone
and
track.
The
nosecone
provides
a
sterile
interface
for
Amigo
to
onnect
to
the
introducer.
The
track
provides
a
sterile
interface
for
the
catheter.
it
2:
Sterile
Cover
Kit
he
pieces
cover
the
sides
and
tops
of
Amigo
and
provide
a
sterile
interface
for
the
whole
system.
it
3:
Docking
Station
Kit
his
kit
is
comprised
of
a
docking
station
and
a
spreader.
This
item
is
specific
to
the
type
of
catheter
used
n
the
procedure
and
can
be
ordered
in
a
Boston
Scientific
Blazer
orientation
or
a
Biosense
–
Webster
EZ
TEER
orientation.
This
kit
allows
the
catheter
to
connect
to
Amigo.
azer
Docking
Station
and
Spreader
EZ
STEER
Docking
Station
and
Spreader