FDA Approval of Rapid Patient Cooling Device in TBI
At the University of Texas Health Science Center researchers have been given FDA approval to study a new rapid cooling device in a clinical trial for patients with traumatic brain injury. Life Recovery Systems’ ThermoSuit(R) System was approved for clinical study under the Investigation Device Exemption by Dr. Guy Clifton at U of T. The study will attempt to determine if the induction of hypothermia in three intervals at 2 and a half hours, four hours and maintained for 48 hours after severe traumatic brain injury will result in an increased number of patients with positive outcomes at six months and twelve months post injury. A previous study performed by the same researchers indicated that later cooling was ineffective in reducing brain injury side effects. “If the study proves to be successful, the ThermoSuit System could potentially benefit thousands of patients with traumatic brain injury,” said Milton Frank, Life Recovery Systems' COO. “Traumatic brain injury is the 'signature wound' of the Iraq war, and LRS is hopeful that early cooling will be beneficial to a number of military casualties.” The study will employ 240 patients and is entitled the National Acute Brain Injury Study: Hypothermia IIR and is being sponsored by the National Institute of Neurological Disorders and Stroke.
