Life Recovery Systems (LRS; Waldwick, New Jersey) is switching gears a bit with its rapid cooling device, the ThermoSuit System.
The device previously has been cleared by FDA for the indication of temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and the med-tech company is now hoping to see if it can be used as therapy for traumatic brain injury patients.
LRS reported FDA approval for the device to be used in a clinical study evaluating its use in these patients. The trial, titled the National Acute Brain Injury Study: Hypothermia IIR, is being conducted by Dr. Guy Clifton and other researchers at the University of Texas Health Science Center (Houston) under an investigational device exemption.
Although researchers launched the study back in 2005, the ThermoSuit System wasn't part of it at its inception. The FDA gave researchers and the company the green light to include it in the study, including 240 patients, this week. The study is expected to end in January of 2011.
LRS said that the study will explore whether the induction of hypothermia to 35 degrees C in two-and-a-half hours after severe traumatic brain injury, and reaching 33 degrees C by four hours after injury and maintained for 48 hours in patients age 16-45, will result in an increased number of patients with positive outcomes at six months and 12 months after injury, compared to patients randomized to normothermia.
Previous research conducted by the Houston-based researchers indicated that later cooling was ineffective in reducing brain injury. The researchers concluded that earlier, more rapid cooling methods are needed to achieve a benefit.
The ThermoSuit is a non-invasive device which reduces core body temperature in a patient to between 33 C and 37 C in a matter of minutes. Visually, it looks somewhat like an inflated water raft, with a thin sheet that covers the patient's entire body. The device connects to a pumping and monitoring system.
"The system continuously pumps a thin film of ice water around the patient's body until the temperature reaches a preset level," Robert Schock, VP of R&D at LRS, told Medical Device Daily. "This unique technology cools patients at a rate of one degree C for every seven minutes of treatment."
After cooling, the patient is removed from the ThermoSuit and can then be transported around the hospital for other therapeutic treatments. Patients cooled with the ThermoSuit System typically stay cold for hours with little or no further maintenance cooling required, according to LRS.
"Earlier this year the investigators expressed interest in including our device," Schock said.
The technology was selected for the current study because of its rapid cooling capabilities, safety and ease of use in an emergency department. While other non-invasive cooling methods typically require hours to cool the patient to the target temperatures specified by this protocol, the ThermoSuit provides the desired cooling in less than 30 minutes.
The study is being sponsored by the National Institute of Neurological Disorders and Stroke. The study currently includes five participating hospitals in addition to the University of Texas.
"If the study proves to be successful, the ThermoSuit System could potentially benefit thousands of patients with traumatic brain injury," said Milton Frank, COO of LRS. "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."
LRS won FDA clearance to market the device in 2006, with the first products delivered in February of 2007. Schock said that the company also has clearances for the device in Europe and Canada.
The company has had a busy year with the ThermoSuit System.
In March it reported FDA approval of an IDE application to investigate rapid hypothermia treatment in combination with primary angioplasty to treat heart attacks. LRS said that previous studies have indicated suggested early and rapid cooling before reperfusion therapy with primary angioplasty may potentially reduce infarct size post-reperfusion.
The angioplasty-related study will enroll at two institutions up to 20 patients who present within six hours of symptom onset and require percutaneous intervention to restore blood flow to the heart. Cooling with the Thermosuit will be performed in the emergency room within 60 minutes of arrival, and cooling time is to be less than 30 minutes to avoid prolonging door-to-balloon time beyond 90 minutes.
That study is being o-chaired by Dr. Paul McMullan and Dr. Christopher White, chairman of cardiology at Ochsner Health System (New Orleans).