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news.Life Recovery Systems, a provider of innovative medical devices for the emergency medical care market, has received a $700,000 grant from the National Institutes of Health to conduct a clinical study to investigate the feasibility of cooling heart attack patients with its ThermoSuit system, the only cooling device using cold water immersion to rapidly lower patient temperature.
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The grant was awarded through the small business innovation research (SBIR) program of the National Heart, Lung and Blood Institute (NHLBI) of National Institutes of Health (NIH). This is the third SBIR grant for Life Recovery Systems from NHLBI. The two previous grants totaling $1.3 million were to develop the ThermoSuit system.
Approximately 20 patients will be enrolled in the study, which will be conducted under an investigational device exemption that was previously granted to Life Recovery Systems by the FDA. The study is a cooperative effort between Life Recovery Systems and the Ochsner Clinic in New Orleans, a division of Ochsner Health System, a non-profit academic and healthcare delivery system with seven hospitals and more than 35 health centers in Southeast Louisiana.
The trial will explore the feasibility of cooling heart attack (ST-elevation acute myocardial infarction) patients with the ThermoSuit System before blood flow is restored to the heart. Patients will be sedated and cooled after entry into the emergency room and prior to percutaneous coronary intervention in the catheterization laboratory.
It is expected that the ThermoSuit System will enable cooling of the patient to 34 degrees centigrade after a treatment of 30 minutes or less and within the 90-minute door to balloon time requirement for treating ST-elevation acute myocardial infarction patients.
A successful result of the study will lead to a pivotal clinical study to investigate the potential for the ThermoSuit cooling treatment to reduce the severity of the heart attack. The ultimate goal of these studies is to obtain FDA clearance for the use of the ThermoSuit system in treating heart attack patients.