Navigation Links
Life Recovery Systems Study of Heart Attack With ThermoSuit(R) System
Date:3/11/2008

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
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
2. 4-Star Gen. Barry Mccaffrey, Former U.S. Drug Czar, to Keynote Recovery Happens! Rally for Treatment: Wed., Sept. 5, 11 Am, State Capitol West Steps, Sacramento
3. Treating depression may improve recovery of heart rate variability following coronary syndromes
4. Recovery Resources Collaborates with Two Nonprofit Agencies for Children of Alcoholics Outreach Program
5. Joint NJ/NY Rally for Addiction Recovery to Be Hub of Events Nationwide
6. CRN Announces Syndication Launch for Recovery Talk Network
7. Altarum Wins $7 Million Contract to Provide Technical Assistance to the Access to Recovery Program
8. The First Mega-Shelter Arrangement in Oregon Created for Major Disaster Response and Recovery
9. Eli Lilly and Company Aids California Recovery Effort
10. Substance abuse practitioners ask what is recovery?
11. Low Levels of Good Cholesterol May Slow Stroke Recovery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... California (PRWEB) , ... December 02, 2016 , ... ... professionals, proudly announces the launch of its 60-day free trial program for all ... trip shipping make the offer a truly hassle free experience. , FlexiSpot’s unique ...
(Date:12/2/2016)... ... ... With the number of pain management programs available for people suffering with constant ... works for them. When an inventor from Suisun City, Calif., was unsuccessful in finding ... it with others. , He developed a prototype for PRO GO MASSAGE to relieve ...
(Date:12/2/2016)... ... December 02, 2016 , ... ... Health" in USA Today, which covers the innovative treatments, therapeutic technologies, and revolutionized ... fulfilling lives. “We are prolonging life 6 years in the last 3 decades,” ...
(Date:12/2/2016)... ... 02, 2016 , ... Sourced from the Isbre Springs beneath the 5,000 year ... natural purity of just 6 ppm TDS (Total Dissolved Solids) in addition to its ... available in several ShopRite and FoodTown stores in NJ and received rave comments from ...
(Date:12/2/2016)... , ... December 02, 2016 , ... ... announced today that it has raised $6.0 million in an initial round of ... Health’s conviction that patients and their caregivers can receive far better care through ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... 2, 2016 bioLytical Laboratories, ein Weltführer bei schnellen ... Mitgliedern des Apothekenbundes von Kenia eingeführt. Continue ... ... HIV Self Test! (PRNewsFoto/bioLytical Laboratories) ...      (Photo: http://photos.prnewswire.com/prnh/20161201/444905 ) bioLytical wurde ...
(Date:12/2/2016)... MONMOUTH JUNCTION, N.J. , Dec. 2, 2016 /PRNewswire/ ... critical care immunotherapy leader commercializing its European Union approved ... in critically-ill and cardiac surgery patients worldwide, announced that ... present at the 9th Annual LD Micro Main ... 8 th , 2016 at the Luxe Sunset Boulevard ...
(Date:12/2/2016)... OLD LYME, Conn. , Dec. 1, 2016 /PRNewswire/ ... consulting, has announced the honor of being selected as ... that include: Simpson Healthcare Executives Website at the PLATINUM ... Directed Conversations Training Module at the GOLD Level, and ... At Simpson Healthcare Executives, we are ...
Breaking Medicine Technology: