BrainCool™ System is a medical device for treating cardiac arrest and stroke. BrainCool™ System has CE approval and the company has received 510 (k) approval from the US Food and Drug Administration (FDA) to market and sell the product in the United States (branded IQool™ System). The system is intended for thermal regulation, to cool and rewarm adult patients when clinically indicated.
BrainCool™ System represents the next generation of temperature control systems designed for surface cooling, and focuses on three independent anatomical zones: head/neck, thighs and torso. BrainCool™ System quickly and efficiently regulates body temperature in adult patients with easily applied pads filled with BC COOL (a biological and non-toxic coolant) connected to an automatic temperature control unit. BrainCool™ System acts within seconds to enable clinicians to handle patient temperature quickly and efficiently, depending on different needs.
BrainCool has initiated a sub-study within the TTM2 trial (Targeted Temperature Management 2) at three hospitals in Stockholm under the leadership of Karolinska Institutet. The study will use RhinoChill™ as soon as in the emergency room and then connect the BrainCool™ System for continued cooling. The combination of these products entails that cooling can be initiated 90-120 minutes before other products in the trial. Early cooling may potentially show clear benefits for stroke and cardiac arrest.
The market launch of the combined product offer is expected in 2019.
Read more about BrainCool™ System here