Enhancing patient care Philips InnerCool Advanced Temperature Modulation Therapy

Philips InnerCool Advanced Temperature Modulation Therapy2

Expanding clinical applicationsThe 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.

Philips InnerCool Advanced Temperature Modulation Therapy 3

Expanding clinical applicationsPublished 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 Therapy4

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

Commitment to scientific innovationPhilips 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.

The Philips InnerCool RTx Endovascular System

for cooling and warming provides rapid cooling

power that enables clinicians to cool awake, non-

paralyzed patients.

Philips InnerCool Advanced Temperature Modulation Therapy 5

Cooling non-paralyzed patientsAs 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 Therapy6

Easy to use, easy to movePhilips 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.

Dynamically modulates temperature (defined as ≥4°C/hr) for rapid cooling, with the option of gradual warming.

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

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

Easy insertion and removal of the proprietary cassette, which enables effective heat exchange via a closed-loop system. The console has an intuitive user interface, and it’s compact and easy to move as needed.

Accutrol™ Catheter – Precise Temperature ControlThe 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

Easy to use, easy to movePhilips 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.

Advanced Pad DesignThe 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.

The console’s compact footprint makes it easy

to move through the hospital.

7Philips InnerCool Advanced Temperature Modulation Therapy

References1 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.

The Philips InnerCool RTx Endovascular System for cooling and warming is a thermal regulating system intended 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 surgery patients in surgery and in recovery/intensive care; and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

Warning – Fever ReductionThe safety of the Philips InnerCool RTx Endovascular System for cooling and warming has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. A randomized, controlled study of endovascular cooling in patients with subarachnoid hemorrhage and primary brain injury has shown increased mortality as compared to patients receiving standard of care.

The Philips InnerCool STx Surface Pad System for cooling and warming for use by trained care-givers only.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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