Physio-Control and BeneChill partner to market therapeutic
hypothermia system
22 Feb 2011
Physio-Control, a wholly-owned subsidiary of Medtronic and
BeneChill, Inc a pioneer in portable therapeutic cooling systems have
formed a strategic partnership to launch the RhinoChill IntraNasal
Cooling System in Europe.
RhinoChill is a non-invasive, portable system for transnasally
cooling the head and lowering the body’s core temperature
immediately following cardiac arrest, stroke or traumatic brain
injury.
Initially, the partnership will focus on bringing the system to
market in the UK, Germany, Austria, Switzerland, Belgium,
Netherlands and Luxemburg during the first quarter of 2011,
utilizing Physio-Control’s extensive European distribution network.
Additionally, as part of this strategic alliance, the two companies
will work jointly to develop additional applications for BeneChill
and work towards making the RhinoChill System available in the US.
“Therapeutic hypothermia can be a vital tool in improving
survival from sudden cardiac arrest and is therefore essential to
our company’s mission,” said Brian Webster, President of Physio-Control.
“We wanted to partner with a cooling solution company that was
innovative and focused on the science. The RhinoChill system fits
well with Physio-Control because it is portable and non-invasive
which allows for use in the pre-hospital environment, where
deployment has the potential to cool patients much earlier and
faster than before.”
“BeneChill is proud to announce our partnership with Physio-Control
– the world’s leading provider of external defibrillation and
monitoring technology,” added Alan Raffensperger, CEO of BeneChill,
Inc. “BeneChill´s mission is to protect the hearts and brains of
patients during cardiac arrest and to improve survival.”
Clinical benefits of therapeutic hypothermia
Therapeutic hypothermia is gaining increasing acceptance
following cardiac arrest in both the pre-hospital and hospital
environments. Landmark clinical studies demonstrating that mild
hypothermia lowers mortality and improves neurological outcome after
successful resuscitation from cardiac arrest were published in 2002.
The European Hypothermia After Cardiac Arrest (HACA) trial group1
demonstrated an improvement in survival to hospital discharge with
favourable neurological status in cooled patients compared with
normothermic patients surviving cardiac arrest (53% versus 36%
respectively), with no significant adverse events from cooling.
The updated 2010 American Heart Association (AHA) and European
Resuscitation Council (ERC) Guidelines for resuscitation and CPR2,3
both confirm the importance of therapeutic hypothermia following
cardiac arrest. The guidelines advise that the earlier cooling is
started during cardiac arrest, the better the outcomes.
The AHA guidelines classify therapeutic hypothermia as a Class I
recommendation, advising the treatment/procedure should be performed
by clinicians. Both sets of guidelines recommend that cardiac arrest
patients are only taken to centers which provide therapeutic
cooling. The ERC guidelines specifically refer to transnasal
evaporative cooling as a method to induce cooling in the
pre-hospital setting.
How RhinoChill works
The RhinoChill System uses a non-invasive nasal catheter that
sprays a rapidly evaporating, inert coolant liquid into the nasal
cavity, a large area situated beneath the brain that acts as a heat
exchanger. As the liquid evaporates, heat is directly removed from
the base of the skull and surrounding tissues via conduction and
indirectly through the blood via convection.
The system is battery-powered, compact and does not require
refrigeration, making it ideal for use in pre-hospital settings.
Each coolant bottle holds enough liquid to cool a patient for 30
minutes at nominal flow, and bottles can be easily exchanged to
maintain the cooling process.
A recently-published European clinical study4 has
shown that when administered by Emergency Medical System (EMS)
personnel as soon as they reach a cardiac arrest victim and
continued during transport to hospital, the RhinoChill System
effectively reduces body temperature by the time the victim reaches
the hospital.
Survival without loss of brain function was significantly
improved in patients where resuscitation procedures and subsequent
RhinoChill cooling were initiated within ten minutes of cardiac
arrest, compared with patients who were not cooled in the
pre-hospital setting.
“The sooner in the resuscitation process you can start to cool
the body following a cardiac arrest, the better the long-term
outcomes are likely to be,” commented lead investigator of the
RhinoChill System European study, Professor Maaret Castren,
Department of Emergency Medicine, Karolinska Institutet /
Sodersjukhuset Hospital, Sweden. “Use of the RhinoChill IntraNasal
Cooling System, which enables cooling to be initiated along with CPR
even before the return of spontaneous circulation, is great news for
patients."
The RhinoChill System received the CE Mark for marketing in the
European Union countries in December 2007. It is initially being
launched in Germany, the United Kingdom, the Netherlands, Belgium,
Luxemburg, Austria and Switzerland. The RhinoChill System is not
currently for sale in the US.
References
1. The HACA Study group. Mild therapeutic hypothermia to improve
the neurologic outcome after cardiac arrest. N Engl J Med
2002; 346(8): 549-556.
2. Peberdy MA, Callaway CW, Neumar RW, Geocadin RG, Zimmerman JL,
Donnino M, Gabrielli A, Silvers SM, Zaritsky AL, Merchant R, Vanden
Hoek TL, Kronick SL. Part 9: post– cardiac arrest care: 2010
American Heart Association Guidelines for Cardiopulmonary
Resuscitation and Emergency Cardiovascular Care. Circulation
2010; 122(suppl 3): S768-S786.
3. Nolan JP, Soar J, Zideman DA et al. European Resuscitation
Council Guidelines for Resuscitation. Resuscitation 2010;
81: 1219-1276.
4. Castren M, Nordberg P, Svensson L et al. Intra-arrest
transnasal evaporative cooling: a randomized, pre-hospital,
multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling
Effectiveness). Circulation 2010; 122: 729-736.