Life Recovery Systems (LRS) has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to test its ThermoSuit system (TSS) in a pivotal trial of ischaemic stroke patients.
The US regulator has given IDE approval for the enrolment of a maximum of 160 patients overall in up to eight hospitals. The study will randomise patients to receive standard care either with or without cooling to 32±1°C. Its primary endpoint will be post-stroke cognitive impairment, while secondary endpoints will include neurological recovery and mortality.
The previous SISCO pilot clinical study—the results of which have been published in Frontiers in Neurology—concluded that the TSS was feasible to use, cooled rapidly and had acceptable safety while also showing trends suggesting improved recovery in ischaemic stroke patients.
“Laboratory studies have predicted that rapid, early cooling would be effective in reducing brain injuries caused by ischaemic strokes, while slow, delayed cooling has failed,” said Robert Schock, vice president of research and development (R&D) at LRS. “Nearly 800,000 Americans suffer strokes each year, and we believe we could help many of them.”
“This is a testament to the unmatched cooling power of the ThermoSuit system,” noted LRS chief executive officer (CEO) Matt Center. “It enhances the investment opportunity in LRS. We are looking forward to pursuing US FDA clearance for the stroke market.”
The TSS uses liquid convection cooling, typically cooling to its target temperature in 40 minutes, according to a recent press release from LRS. The release also states that core temperature is monitored while cooling and, at about 33°C, the water and patient are removed from the suit. The patient is then maintained at target for 24 hours with conventional surface cooling.
LRS further notes that this clinical trial IDE does not represent a final regulatory clearance for an ischaemic stroke indication with the TSS—and that the current US FDA-cleared indications for the device are temperature reduction where clinically indicated, such as in hyperthermic patients, and temperature monitoring.
