FOR IMMEDIATE RELEASE
Friday, August 5, 2019
FDA APPROVES EXPANSION OF CLINICAL STUDY INVESTIGATING COOLING OF STROKE PATIENTS
Life Recovery Systems has been granted approval by the US Food and Drug Administration (FDA) to expand its clinical study of the use of the ThermoSuit® System in the treatment of ischemic stroke (the “SISCO” study, which is being conducted under an investigational device exemption (IDE)). The recent study amendments expand the study entrance criteria to include patients receiving neurothrombectomy treatments. Under the revised IDE up to four hospitals are now allowed to participate in the study. The Institutional Review Board (IRB) of Tulane University has granted its renewed approval to continue the study, and a second site, Rapides Regional Medical Center, has joined the study. The company is seeking two additional sites to help with the investigation.
According to Dr. Robert Schock, Vice President of R&D for the firm, “We are pleased with the results that we have seen thus far as our rapid cooling treatment has been investigated in victims of stroke. Preliminary data predict that cooling will be most effective if provided close to the time of reperfusion.” Patients in the trial are being cooled while under sedation, with the intent of reaching a state of therapeutic hypothermia in approximately 30 minutes.
The ThermoSuit System uses direct liquid contact with the patient to reduce core body temperature. A thin film of ice water is circulated over the patient’s body until the temperature reaches a pre-set limit, at which point the water is automatically removed from the suit. The system is easily set up by nurses or technicians in minutes and cools to a therapeutic temperature of 33˚C in about 30 minutes. The patient is then removed from the suit and remains cold for hours without the need for further maintenance, allowing unencumbered access for subsequent imaging or treatment.
A similar trial investigating the cooling of victims of acute myocardial infarction (“CHIPAHA”) has also received IDE approval, and will be pursued at a later date, using input obtained from the SISCO stroke trial.
About Life Recovery Systems
Contact: Robert Schock
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