BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Life Recovery Systems Study of Heart Attack With ThermoSuit(R) System


3/12/2008 11:52:11 AM

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 www.life-recovery.com.

Ochsner Health System (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.

CONTACT: John DiLiddo of Life Recovery Systems, HD, LLC, +1-973-283-2800,
jdiliddo@life-recovery.com

Web site: http://www.life-recovery.com/
http://www.ochsner.org/



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES