Life Recovery Systems (Alexandria, Louisiana) reported FDA approval of an Investigational Device Exemption (IDE) application to investigate rapid hypothermia treatment in combination with primary angioplasty to treat heart attacks.

Life Recovery 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 study will enroll at two institutions up to 20 patients 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 ThermoSuit 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 (New Orleans).

In the Cool MI I trial a subset of patients with antrior 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. Primary safety endpoints data will also be collected. If this trial successfully achieves it its endpoints, a larger prospective randomized trial will be conducted.

"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," said John DiLiddo, VP marketing and sales for Life Recovery. A second U.S. site is in the process of being chosen.

The company said its 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." I added: "A successful trial outcome could impact in a positive way thousands of patients each year worldwide who suffer severe acute myocardial infarctions.