FDA Approves Studies into Cooling of Heart Attack and Stroke Patients

The U.S. FDA has approved two investigational device exemptions (IDE’s) to study the use of the Life Recovery Systems ThermoSuit® in the treatment of heart attack and ischemic stroke.

Background

New to our pages, Life Recovery Systems focuses on ground breaking, innovative medical devices for the emergency medical care market. Its first product, the ThermoSuit System, was developed with the assistance of NIH NHLBI funding to provide physicians and nurses with a safe, convenient, and extremely rapid method for cooling patients and has already received FDA 510(k) clearance for “temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients.”

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 imaging or treatment in the Cath. Lab.

Company comments

According to Dr. Robert Schock, Vice President of R&D for the firm, “We are eager to see our rapid cooling treatment evaluated in victims of heart attack and stroke, as preliminary data predict that cooling will be most effective if it is provided close to the time of reperfusion.” Patients in both trials will be cooled while under sedation, with the intent of reaching a state of therapeutic hypothermia in approximately 30 minutes or less.

Source: Life Recovery Systems, PR Newswire

 

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