KINNELON, N.J., and ALEXANDRIA, La., March 11 /PRNewswire/ -- Life Recovery Systems, HD, LLC announced today approval by the Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) application to investigate rapid hypothermia treatment in combination with primary angioplasty to treat heart attacks.
Previous clinical data suggested early and rapid cooling before reperfusion therapy with primary angioplasty may potentially reduce infarct size post reperfusion. The study will enroll up to twenty patients at two institutions who present within six hours of symptom onset and require PCI to restore blood flow to the heart. Patients will receive hypothermia with the Life Recovery Systems ThermoSuit(R) non-invasive cooling system. Cooling 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.
The study is co-chaired by Dr. Paul McMullan and Dr. Christopher White, Chairman of Cardiology for Ochsner Health System in New Orleans, LA.
In the Cool MI I trial(1) a subset of patients with anterior infarctions and whose temperature at the time of reperfusion was below 35 degrees C (26% of all anterior MI's in the cooled group) had a significantly smaller infarction (9.3% of the left ventricular mass in the cooled population vs. 18.2% in the control group p=0.05) than the control group, said Dr. Paul McMullan.
The goal of this pilot study is to confirm the feasibility and efficacy of external thin film liquid cooling to achieve "target" temperature within 30 minutes or less, and to demonstrate ease of maintenance of target temperature for three hours following removal of the patient from ThermoSuit(R). Primary safety endpoints data will also be collected. If this trial successfully achieves it its endpoints, a larger prospective randomized trial will be conducted.
Life Recovery Systems is pleased to be working with world-renowned cardiologists from Ochsner Health System to study ThermoSuit(R) cooling in the Acute MI patient population. "We believe our rapid non-invasive cooling system has the ability to cool Acute MI patients to target temperature rapidly in the emergency room in preparation for PCI reperfusion therapy," stated John DiLiddo, VP Marketing & Sales for Life Recovery Systems. A second U.S. site is in the process of being chosen and will be announced in the near future.
Our goal is to rapidly cool the patient to target temperature in less than 30 minutes in preparation for PCI and without exceeding the AHA/ACC guidelines for door-to-balloon time. A successful trial outcome could impact in a positive way thousands of patients each year worldwide who suffer severe Acute Myocardial Infarctions.
Life Recovery Systems, HD, LLC is focused on developing and providing groundbreaking, innovative medical devices for the emergency medical care market. The company's mission is to save and preserve the quality of lives. To learn more, visit us at http://www.life-recovery.com.
Ochsner Health System (http://www.ochsner.org) is a non-profit, academic, multi- specialty, healthcare delivery system dedicated to patient care, research and education. The system includes seven hospitals, a sub-acute facility, and 33 health centers located throughout Southeast Louisiana. Ochsner employs over 600 physicians in 80 medical specialties and subspecialties and 450 clinical research trials annually. Ochsner was ranked one of the "Best Places to Work" by New Orleans City Business in 2005, 2006 and 2007 and received the Consumer Choice for Healthcare in New Orleans for 12 consecutive years. Ochsner was ranked as "Best" Hospital by U.S. News and World Report in July 2007. Ochsner has over 10,000 employees system-wide.
1. O'Neill, W.W. A Prospective Randomized Trial of Mild Systemic
Hypothermia During PCI Treatment of ST Elevation MI (The COOL MI Trial)
in Transcatheter Cardiovascular Therapeutics. 2003. Washington, D.C.
|SOURCE Life Recovery Systems, HD, LLC|
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