News | February 09, 2011

Partnership Formed to Bring Therapeutic Hypothermia System to Europe

February 9, 2011 – A partnership has been formed to launch a portable therapeutic cooling system in Europe. Physio-Control and BeneChill will work together to launch the RhinoChill IntraNasal Cooling System, a noninvasive system for transnasally 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 United Kingdom, Germany, Austria, Switzerland, Belgium, Netherlands and Luxemburg during the first quarter of 2011. 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 United States.

Because the system can be used in the pre-hospital environment, it has the potential to cool patients much earlier and faster than before, according to Brian Webster, president of Physio-Control.

Landmark clinical studies have demonstrated that mild hypothermia lowers mortality and improves neurological outcome after successful resuscitation from cardiac arrest. The European Hypothermia After Cardiac Arrest (HACA) trial demonstrated an improvement in survival in cooled patients compared with normothermic patients surviving cardiac arrest (53 percent versus 36 percent respectively), with no significant adverse events from cooling.

The updated 2010 American Heart Association (AHA) and European Resuscitation Council (ERC) Guidelines for resuscitation and CPR 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 advise that therapeutic hypothermia 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.

The RhinoChill System uses a non?invasive nasal catheter that sprays a rapidly evaporating, inert coolant liquid into the nasal cavity. 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 European clinical study has shown that the RhinoChill System can effectively reduce 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 10 minutes of cardiac arrest.

“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,”, said professor Maaret Castren, lead investigator of the RhinoChill system European study, 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 in December 2007. It is not currently for sale in the United States.

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