Enhancing patient care

Philips InnerCool Advanced Temperature Modulation Therapy

 Expanding clinical
The practice of modulating the body’s temperature to improve patient outcomes has
been used in limited settings, such as during neurosurgery and cardiac surgery, dating
back to the 1950’s.1 While commonly referred to as “therapeutic hypothermia” or
“cooling,” Temperature Modulation Therapy (TMT) more broadly encompasses inducing,
maintaining, and reversing hypothermia, as well as maintaining normal body temperature
or normothermia. Clinical research and technological developments are expanding the
potential applications in which this innovative approach can help improve outcomes.

2 Philips InnerCool Advanced Temperature Modulation Therapy

applications
Published studies in leading medical
journals, including the New England Journal
of Medicine, 2,3 Stroke,4 Neurosurgery, 5 Critical
Care Medicine,6 and Neurocritical Care7 are
providing insights into an expanding range
of possible TMT applications, including
stroke, acute myocardial infarction, sudden
cardiac arrest, and fever control. These
studies demonstrate the clinical impact
of temperature modulation therapy for
protecting critical organs following cardiac
arrest, myocardial infarction (prior to
revascularization), and other traumatic
injury, as well as protecting the brain of
subarachnoid hemorrhage patients.
Momentum is building for the use of TMT
in clinical practice with support coming from
ground-breaking recommendations from
both the American Heart Association and
the International Liaison Committee on
Resuscitation. 8,9
Technological advances are helping drive
the potential of new patient applications.
Previously, only rudimentary surface cooling
options, such as ice packs or blankets, were
available to support temperature modulation
therapy protocols. Advances in surface
cooling technologies, specifically around pad
design, have improved surface contact and
the critical heat exchange process, as well as
made these technologies easier to use. The
availability of innovative endovascular systems
that can be easily set up and used on non-
paralyzed, awake patients also has broadened
the types of patients who can benefit from
Temperature Modulation Therapy.

“Repeated randomized controlled trials show

that therapeutic hypothermia markedly
improves the chances of a good clinical
outcome in patients with brain injury
from global ischemia. Hypothermia is also
profoundly neuroprotective in many other
forms of experimental CNS injury, and
clinical trials are ongoing or planned for
many further indications.”
Robert Silbergleit, MD
Associate Professor Department of Emergency Medicine
Neurological Emergencies Treatment Trials CCC
University of Michigan

Philips InnerCool Advanced Temperature Modulation Therapy 3

Fastest cooling rates
Philips is leading the way in advanced temperature
modulation therapy with comprehensive, science-driven
solutions. Only Philips introduces both endovascular and
surface cooling and warming systems with its InnerCool
family of products to address the specific needs of your
patients, your hospital, and your clinical practice.
As the first endovascular temperature modulation
therapy solution available in the U.S., Philips
technologies are backed by over 10 years of research.
The results have been reported in numerous published,
peer-reviewed journals, such as Neurocritical Care,7
Academic Emergency Medicine,10 and Journal of Stroke and
Cerebrovascular Diseases.11
The Philips InnerCool RTx Endovascular System
for cooling and warming provides rapid cooling
power that enables clinicians to cool awake, non-
paralyzed patients.
4 Philips InnerCool Advanced Temperature Modulation Therapy
Commitment to scientific innovation
Philips commitment to developing science-driven
temperature modulation therapy solutions has resulted
in several unique advances, including:
• Fastest cooling rates in the industry using dynamic
temperature modulation (defined as a change in
temperature of ≥4°C/hr) for rapid cooling5
• Precise temperature control with the only catheter
featuring an integrated temperature sensor5
• Cooling non-paralyzed patients who are either awake
or unconscious11
• Rapid cooling of patients with high BMI (>30kg/m2)
who often are considered “difficult-to-cool”5
The Philips InnerCool STx Surface Pad System
for cooling and warming provides a cost-effective,
easy-to-use solution with an advanced pad design
for non-invasive temperature modulation therapy.
Cooling non-paralyzed patients
As a matter of survival, our physiology resists being
cooled. Shivering, the body’s natural defense to cooling,
produces more body heat. Shivering also increases
overall metabolic activity, dramatically increasing
oxygen demand and consumption. This can have
deleterious effects for patients who have suffered
a global ischemic event. Overcoming this increase
in metabolic heat is a daunting task which, for most
cooling systems, requires that the physician paralyze
the patient to eliminate shivering. Even then, time to
target temperature is, at best, a few hours.
The challenge is to quickly get below the shivering
threshold, where diminished shivering results
in less resistance to cooling therapy and fewer
complications. This unique approach to therapeutic
hypothermia rapidly achieves maximum cooling for
neuroprotection and is comfortable for the patient,
while avoiding risks inherent with paralytic agents
such as masking seizures or masking inadequate levels
of sedation. The InnerCool RTx extracts heat at a
very fast rate, rapidly cooling patients and reducing
the time period and amount of pharmacological agents
that are required to eliminate shivering. The rapid
cooling power of the InnerCool RTx enables clinicians
to cool awake, non- paralyzed patients.11
Philips InnerCool Advanced Temperature Modulation Therapy 5
 Easy to use, easy to
Philips InnerCool RTx Endovascular System
The Philips InnerCool RTx Endovascular System for
cooling and warming provides advanced whole body
temperature modulation therapy in a closed-loop system
from the inside out.
Effectively cools across the full spectrum of
patients, including those with high body mass index
(BMI) (>30kg/m2), who often are considered difficult
to cool. 5

Dynamically modulates temperature (defined as Easy insertion and removal of the proprietary
≥4°C/hr) for rapid cooling, with the option of gradual cassette, which enables effective heat exchange via a
warming. closed-loop system. The console has an intuitive user
interface, and it’s compact and easy to move as needed.
Fastest cooling and warming rates in the industry
• Average cooling rates of 4.0 – 5.0°C/hr5
• Average warming rates of 2.0 – 3.0°C/hr5
• Gradual warming of 0.1 – 1.2°C/hr

Cools non-paralyzed patients who are either

awake or unconscious.11

Accutrol™ Catheter – Precise

Temperature Control
The Accutrol™ Catheter is the only
temperature modulation catheter with
an integrated temperature sensor. This
innovative catheter design supports
precise temperature control during the
therapeutic induction and maintenance
process. The highly responsive sensor
avoids the lag in core temperature
measurement inherent in rectal
and bladder sensors. Precise temperature control helps avoid
overshooting the target temperature. 5
• Flexible, metallic design optimizes heat exchange
• Covalently bonded heparin-coating
• Small profile maintained in situ, unlike catheters with
inflatable balloons
• Incidence of catheter-related infections no greater than
placement of central venous lines5
• Can be used in situ during “head only” MRI procedures

6 Philips InnerCool Advanced Temperature Modulation Therapy

move
Philips InnerCool STx Surface Pad System
The Philips InnerCool STx Surface Pad System for
cooling and warming provides a cost-effective, easy-to-
use solution with an advanced pad design for non-
invasive temperature modulation therapy.

Easy-to-Use Console
With an intuitive user interface and a choice of manual
or automatic modes, the STx Surface Pad System can be
initiated in the Emergency Room, Intensive Care Unit, or
Cath Lab by trained caregivers.

The console’s compact footprint makes it easy

Advanced Pad Design
to move through the hospital.
The STx Surface Pad System uses an easy-to-apply
surface vest and thigh pads. With no adhesives
contacting the skin, there is less risk of skin irritation.
Yet, the pads provide tight skin contact for effective
cooling and warming.

Philips advanced design makes pads suitable for

prolonged use and provides easy access for patient care
throughout treatment.

Philips InnerCool Advanced Temperature Modulation Therapy 7

Philips Healthcare is part of The Philips InnerCool RTx Endovascular System for cooling
and warming is a thermal regulating system intended
Royal Philips Electronics to induce, maintain, and reverse mild hypothermia in
neurosurgical patients in surgery and in recovery/intensive
care; to achieve and/or maintain normothermia in cardiac
How to reach us surgery patients in surgery and in recovery/intensive care;
www.philips.com/healthcare and for use in fever reduction, as an adjunct to other
antipyretic therapy, in patients with cerebral infarction
healthcare@philips.com and intracerebral hemorrhage who require access to the
fax: +31 40 27 64 887 central venous circulation and who are intubated and
sedated.
Asia Warning – Fever Reduction
The safety of the Philips InnerCool RTx Endovascular
+852 2821 5888 System for cooling and warming has not been
demonstrated for fever reduction in patients presenting
with subarachnoid hemorrhage or primary traumatic brain
Europe, Middle East, Africa injury. A randomized, controlled study of endovascular
+49 7031 463 2254 cooling in patients with subarachnoid hemorrhage and
primary brain injury has shown increased mortality as
compared to patients receiving standard of care.
Latin America
The Philips InnerCool STx Surface Pad System for cooling
+55 11 2125 0744 and warming for use by trained care-givers only.
Caution: Federal (USA) law restricts this device to sale by
North America or on the order of a physician.
+1 425 487 7000
800 285 5585 (toll free, US only)
Please visit www.philips.com/innercool
© 2010 Koninklijke Philips Electronics N.V.
All rights are reserved.
Philips Healthcare reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or
obligation and will not be liable for any consequences resulting from the use of this publication.
Printed in The Netherlands.
4522 962 58021 * FEB 2010
References
1 Bigelow WG, Callaghan JC, Hopps JA. General
hypothermia for experimental intracardiac surgery;
the use of electrophrenic respirations, an artificial
pacemaker for cardiac standstill and radio-frequency
rewarming in general hypothermia. Ann Surg.
1950;132(3):531–539.
2 Bernard SA, Gray TW, Buist MD, et al. Treatment of
comatose survivors of out-of-hospital cardiac arrest with
induced hypothermia. N Eng J Med. 2002;346:557-563.
3 The Hypothermia After Cardiac Arrest Study
Group. Mild therapeutic hypothermia to improve
neurological outcome after cardiac arrest. N Eng J Med.
2002;346:549-556.
4 Holzer M, Mullner M, Sterz F, et al. Efficacy and safety of
endovascular cooling after cardiac arrest: Cohort study
and Bayesian approach. Stroke. 2006;37:1792-1797.
5 Steinberg GK, Ogilvy CS, Shuer LM, et al. Comparison
of endovascular and surface cooling during unruptured
cerebral aneurysm repair. Neurosurgery. 2004;55:307-315.
6 Oddo M, Schaller MD, Feihl F, et al. From evidence to
clinical practice, effective implementation of therapeutic
hypothermia to improve patient outcome after cardiac
arrest. Crit Care Med. 2006;34:1865-1873.
7 Badjatia N, O’Donnell J, Baker JR, et al. Achieving
normothermia in patients with febrile subarachnoid
hemorrhage. Feasibility and safety of a novel
intravascular cooling catheter. Neurocritical Care.
2004;1:145-156.
8 2005 American Heart Association Guidelines for
Cardiopulmonary Resuscitation and Emergency
Cardiovascular Care. Part 7.5: Postresuscitation
Support. Circulation. 2005;112:IV-84-IV-88.
9 Nolan JP, Morely PT, Hoek TL, et al. Therapeutic
hypothermia after cardiac arrest: An advisory statement
by the Advanced Life Support Task Force of the
International Liaison Committee on Resuscitation.
Resuscitation. 2003;57:231-235.
10 Guluma KZ, Hemmen TM, Olsen SE, et al. A trial
of therapeutic hypothermia via endovascular
approach in awake patients with acute ischemic
stroke: Methodology. Academic Emergency Medicine.
2006;13:820-827.
11 Lyden PD, Allgren RL, Ng K, et al. Intravascular cooling in
the treatment of stroke (ICTus): Early clinical experience.
J Stroke Cerebrovascular Dis. 2005;14:107-114.
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