March 11, 2008 – The FDA cleared an investigational device exemption (IDE) application from Life Recovery Systems to use the ThermoSuit noninvasive cooling system 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. Life Recovery Systems’ said its objective 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.
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 noninvasive 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 Paul McMullan, M.D., and Christopher White, M.D., chairman of cardiology for Ochsner Health System in New Orleans, LA.
In the Cool MI I trial, a subset of patients with anterior infarctions and whose temperature at the time of reperfusion was below 35 degrees C (26 percent of all anterior MI’s in the cooled group) had a significantly smaller infarction (9.3 percent of the left ventricular mass in the cooled population vs. 18.2 percent in the control group p=0.05) than the control group, indicated Dr. 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.
For more information: www.life-recovery.com and www.ochsner.org