INSPIRE

TM

Inspired choice

Personalized perfusion
because no two of your patients are the same
Leveraging worldwide leadership INSPIRE
TM

Our vision becomes reality

LivaNova is committed to providing solutions that advance patient outcomes
and exceed our customers expectations. LivaNova INSPIRE is a completely
new family of adult oxygenators designed from years of research and laboratory
experience, input from clinical experts from around the world and the
application of advanced manufacturing technologies that adhere to the
highest quality standards.

Our vision when designing this new family of oxygenators was to raise
performance expectations and ease of use, while providing clinicians with
new options to improve outcomes in cardiopulmonary bypass.

Our vision is now a reality.

RESERVOIR
Dual Chamber Single Chamber Single Chamber

OXY MODULES INTEGRATED

INSPIRE 6 DUAL INSPIRE 6

TM TM

6 LPM w/o Filter PH.I.S.I.O. PH.I.S.I.O.

INSPIRE 6F DUAL INSPIRE 6F

TM TM

6 LPM with Filter PH.I.S.I.O. PH.I.S.I.O.

INSPIRE 8 DUAL INSPIRE 8

TM TM

8 LPM w/o Filter PH.I.S.I.O. PH.I.S.I.O.

INSPIRE 8F DUAL INSPIRE 8F

TM TM

8 LPM with Filter PH.I.S.I.O. PH.I.S.I.O.

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Inspired by... INSPIRE
TM

...technology
A completely new family of adult oxygenators

THE MOST COMPLETE FAMILY OF ADULT OXYGENATORS

The INSPIRE family has been designed to be fully modular, allowing clinicians an unprecedented choice.
The family features ten integrated oxygenator systems, created by combining three Hard-Shell Venous
Reservoirs (HVR) and four oxygenator modules.

DESIGNED TO MEET ALL ADULT PATIENT NEEDS AND

PERFUSION PRACTICES
To best fit the variety of perfusion practices and adult patient needs, the new family features:
• Full size adult 8 LPM and optimized size adult 6 LPM oxygenator modules, both with and without an
integrated arterial filter.
• Single chamber Hard-Shell Venous Reservoirs (HVR) and unique DUAL chamber HVR reservoirs for
advanced perfusion practices.

UTMOST PERFORMANCE
The new INSPIRE Family allows clinicians to safely and comfortably run perfusion while guaranteeing
powerful, consistent performance. Its long path oxygenator membrane with remakably efficient longitudinal
flow design allows high gas exchange at all rated flows. Its polyurethane heat exchanger is capable of
highly efficient heat transfer.

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Inspired by... INSPIRE
TM

...the voice of clinicians

Addressing the key challenges in adult perfusion

MINIMIZED IMPACT ON HEMODILUTION

Minimizing hemodilution contributes to decreased blood transfusions and improved clinical outcomes
during and after cardiopulmonary bypass (CPB). By focusing on a new attribute, the oxygenator system
dynamic operating volume (DOV), the INSPIRE family minimizes the overall impact on hemodilution.
INSPIRE devices are characterized by the lowest minimum operating level in the reservoir (150 ml),
outstanding low venous filter dynamic hold-up volume and low prime oxygenator modules.

EFFECTIVE GASEOUS MICRO EMBOLI CONTROL

Gaseous microemboli are commonly indicated as potential sources of neurological damage after
CPB. Dedicated design solutions within the INSPIRE HVR and HVR DUAL and in the INSPIRE oxygenator
modules ensure effective gaseous microemboli (GME) control. The integrated arterial filter design,
thanks to its dedicated compartment, offers superior GME handling compared to competitive
designs, while ensuring minimized impact on hemodilution.

SAFE, EASY AND FLEXIBLE

The INSPIRE family is flexible and versatile. INSPIRE is the most vertically compact oxygenator system
on the market today. It allows optimal handling during the case and minimal storage on the shelf.
A single, newly designed bracket fits the entire family for maximum convenience. Ergonomics, port
orientation and system priming have been optimized to offer easy set-up and operational flexibility.

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Inspired by... INSPIRE
TM

...Innovation
Leading perfusion innovation for more than 40 years

ADULT PATIENT POPULATION AND OXYGENATOR OF CHOICE

Patient Body Weight & Distribution per INSPIRE Market Assessment Study (MAS) database

≈ 50% < 80 Kg ≈ 40% ≤ 100 Kg ≈ 10% > 100 Kg

5 LPM 6 LPM
Yesterday's choice

SMALL ADULT FULL ADULT

LivaNova's vision

6 8
SMALL ADULT From 5 to 6 LPM max blood flow rate

Today's choice with INSPIRE

OPTIMIZED ADULT FULL ADULT

OPTIMIZED PERFUSION FOR A WIDER PATIENT POPULATION

The goal of optimized perfusion is to minimize the impact of CPB on patient outcomes by
reducing hemodilution and blood contact surface area, minimizing GME and improving
biocompatibility, while providing high performance. Until INSPIRE, small adult devices
have been considered the benchmark for optimized perfusion, but were limited in flow
to 5 LPM. The new INSPIRE 6 LPM optimized adult oxygenator systems extend the
benefits of small adult devices to a wider patient population.

ENHANCING SYSTEM BIOCOMPATIBILITY

Full biocompatibilty includes reducing the multiple sources of cellular activation and
inflammatory reaction. Coatings reduce platelet and white blood cell adhesion to the cir-
cuit. Suction blood contains activated cells and stimulates additional activation. Combined,
sequestering suction blood and using coated circuits offers maximum biocompatible benefit.
The INSPIRE DUAL Reservoir system provides clinicians new options for activated suction ma-
nagement.
The combination of the INSPIRE DUAL Reservoir system, PHISIO PC coating and LivaNova XTRA
autotransfusion system, offers clinicians a comprehensive solution to enhanced
biocompatibility.

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 INSPIRE
TM

Proven by clinical use

Outstanding feedback from clinicians
Overall an easy to set up system, with good heat exchanger performance,
very good gas exchange performance. Easy to prime, great visibility of components.
Lower prime volume, less hemodilution and potentially less blood product usage.
Holder and brackets work very well.

EXTENSIVE MARKET ASSESSMENT STUDY

INSPIRE was extensively evaluated by conducting a global Market Assessment Study (MAS) before
commercial launch. The study evaluated INSPIRE clinically on over 2000 patients at 80 centers in 24
countries. The MAS experience collected input from over 250 clinicians, resulting in a comprehensive
database that provides an invaluable source of information for data analysis.

CONSISTENT FEEDBACK
Listening to clinician’s feedback is a crucial part of our mission. Reduction in priming volume, reservoir
performance, gas exchange and heat exchange were consistently rated as the most compelling
features of the INSPIRE devices. Clinicians participating in the MAS were asked to suggest enhancements
to make INSPIRE even better. Several of these were implemented to finalize the design before launch.

ADDITIONAL CLINICAL BENEFITS

In the MAS study, a vast majority of clinicians felt INSPIRE helped them provide additional clinical
benefits to their patients. Overall, when compared to the oxygenator systems currently used, the
INSPIRE devices were reported to provide higher hematocrit during CPB, reduce priming volume
and allow lower blood level in the reservoir.

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 INSPIRE
TM

The first cardiopulmonary bypass system

From products to complete solutions

HEARTLINK SYSTEM TM

LivaNova’s products for cardiopulmonary bypass have helped clinicians provide safe and effective perfu-
sion for more than 40 years. Today, LivaNova has decided to move one step further by offering not only
single products but a complete cardiopulmonary bypass system: LivaNova HeartLinkTM. Based on our
world leading heart lung machine technology, LivaNova HeartlinkTM is the first perfusion system to provide
a unique link between perfusion data, patient parameters and product information to assist with Goal
Directed Perfusion principles, because patient outcome and practice improvement is our common goal.

LINKING THE PERFUSION SYSTEM TOGETHER

Cardiopulmonary bypass generates a large amount of data, which must be considered during the case
and recorded as part of the patient record. LivaNova ConnectTM can offer an innovative link that assists
with managing information from multiple sources. By integrating INSPIRE perfusion circuit information
with the LivaNova S5/C5 Heart Lung machines, LivaNova XTRA Autotransfusion system and other devices,
clinicians can now have improved traceability accuracy and automatic case data logging. This system will
allow clinicians to focus on critical patient care activities, rather than recording data.

A NEW PARADIGM: GOAL-DIRECTED PERFUSION

The collected information from LivaNova ConnectTM can also be displayed in real time to support per-
fusionists. The new GDP MonitorTM, available only as part of LivaNova ConnectTM, can assist clinicians in
their effort to monitor and continuously improve the quality of perfusion. LivaNova GDP MonitorTM is the
new feature inside LivaNova ConnectTM that allows the implementation and monitoring of Goal Directed
Perfusion principles in the operating room to quantify the adequacy of perfusion for each patient, which
may contribute to shortening ICU & hospital length of stay.

CONNECT TM

INSPIRE S5
TM TM

XTRA

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INSPIRE TM
ORDER GUIDE ITEM # DEVICE DESCRIPTION UNITS PER CASE

INTEGRATED
050713 INSPIRE 6 INSPIRE 6 LPM PHISIO OXY MODULE WITH INTEGRATED PHISIO 2
HARD SHELL VENOUS RESERVOIR
050715 INSPIRE 6F INSPIRE 6 LPM PHISIO OXY MODULE WITH INTEGRATED ARTERIAL 2
FILTER AND PHISIO HARD SHELL VENOUS RESERVOIR
050717 INSPIRE 6 DUAL INSPIRE 6 LPM PHISIO OXY MODULE WITH INTEGRATED PHISIO 2
DUAL CHAMBER HARD SHELL VENOUS RESERVOIR
050719 INSPIRE 6F DUAL INSPIRE 6 LPM PHISIO OXY MODULE WITH INTEGRATED ARTERIAL 2
FILTER AND PHISIO DUAL CHAMBER HARD SHELL VENOUS RESERVOIR
050714 INSPIRE 8 INSPIRE 8 LPM PHISIO OXY MODULE WITH INTEGRATED PHISIO 2
HARD SHELL VENOUS RESERVOIR
050716 INSPIRE 8F INSPIRE 8 LPM PHISIO OXY MODULE WITH INTEGRATED ARTERIAL 2
FILTER AND PHISIO HARD SHELL VENOUS RESERVOIR
050718 INSPIRE 8 DUAL INSPIRE 8 LPM PHISIO OXY MODULE WITH INTEGRATED PHISIO 2
DUAL CHAMBER HARD SHELL VENOUS RESERVOIR
050720 INSPIRE 8F DUAL INSPIRE 8 LPM PHISIO OXY MODULE WITH INTEGRATED ARTERIAL 2
FILTER AND PHISIO DUAL CHAMBER HARD SHELL VENOUS RESERVOIR
050711 INSPIRE 6 START P INSPIRE 6 LPM PHISIO OXY MODULE WITH INTEGRATED 2
HARD SHELL VENOUS RESERVOIR
050712 INSPIRE 8 START P INSPIRE 8 LPM PHISIO OXY MODULE WITH INTEGRATED 2
HARD SHELL VENOUS RESERVOIR

OXY MODULES
050700 INSPIRE 6 M INSPIRE 6 LPM PHISIO OXY MODULE 2

050702 INSPIRE 6F M INSPIRE 6 LPM PHISIO OXY MODULE WITH INTEGRATED ARTERIAL FILTER 2

050701 INSPIRE 8 M INSPIRE 8 LPM PHISIO OXY MODULE 2

050703 INSPIRE 8F M INSPIRE 8 LPM PHISIO OXY MODULE WITH INTEGRATED ARTERIAL FILTER 2

HVR
050704 INSPIRE HVR INSPIRE PHISIO HARD SHELL VENOUS RESERVOIR 2

050705 INSPIRE HVR DUAL INSPIRE PHISIO DUAL HARD SHELL VENOUS RESERVOIR 2

ACCESSORIES
050640 INSPIRE BKT BRACKET FOR INSPIRE OXY MODULES AND INTEGRATED 1
OXYGENATOR SYSTEMS

48-42-10 INSPIRE BKT FAST* BRACKET FOR INSPIRE OXY MODULES AND INTEGRATED 1
OXYGENATOR SYSTEMS WITH FAST CLAMP

02/16 09295-128/B
050641 INSPIRE BKTH BRACKET FOR INSPIRE HVR AND DUAL HVR RESERVOIRS 1

042229000 TEMPERATURE PROBES TEMPERATURE PROBES 2

* To be ordered as an accessory of Sorin S5 and C5 HLMs

LivaNova’s Green Leaf program

EN ISO 13485:2012/AC 2012

Manufactured by:
Sorin Group Italia Srl
A wholly-owned subsidiary of LivaNova Plc
Via Statale 12 Nord, 86
41037 Mirandola (MO) Italy
Теl: +39 0535 29811 - Fax: +39 0535 25229
[email protected]

Please always refer to the Instructions For Use (IFU) manual provided with each product for detailed information, warnings, precautions and possible adverse side effects.

© 2016 LivaNova all rights reserved.