RhinoChill is a portable, battery-powered and non-invasive product for rapid and early medical cooling for treatment of sudden cardiac arrest and stroke. With the help of a catheter, coolant is sprayed into the nostrils. Cooling lasts for up to two hours. RhinoChill is suitable for use before arriving at the hospital and is intended for treatment by ambulance personnel, emergency services and intensive care units (ICU).
RhinoChill is undergoing a process for FDA approval via a de novo 510 procedure. As a basis approval, the PRINCESS study will be used with Karolinska Institutet. The Novo process has been introduced by the FDA for new products where there is no similar product to support a standard 510 (k) application.
The results of previous European clinical trials of 200 patients at several centers (PRINCE study published in Circulation 2010) showed that when RhinoChill was used in conjunction with cardiac arrest, the temperature in the brain reached protective levels several hours earlier compared to patients chilled by traditional methods at intensive care units. Although the PRINCE study was not designed to show survival benefits, it showed clear positive effects in early cooling, which contributed to further research and ensured major clinical trials. Among patients who survive on arrival at hospitals, the PRINCE study showed that 44 percent of patients cooled with RhinoChill left the hospital alive compared to 31 percent who were not cooled with RhinoChill. Survival rates for patients who received early cardiopulmonary resuscitation were even better, 57 percent and 29 percent, respectively. The aim of the ongoing PRINCESS study is to obtain further evidence and answers to the benefits of early cooling after cardiac arrest. The results of the study are expected to be presented at the American Heart Association Congress in November of 2018.
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