AHA Gives New Rating to Medical Device

Posted: Thursday, December 1, 2005
Updated: July 8th, 2008 05:26 PM GMT-05:00
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AHA Gives New Rating to Medical Device






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via PRNewswire

MINNEAPOLIS , Dec. 1 /PRNewswire/ -- Advanced Circulatory Systems, Inc., announced today that its ResQPOD(R) has been given a Class IIa recommendation by the American Heart Association (AHA) in its recently released guidelines for CPR and emergency cardiac care.

Specifically, the rating has been given to an impedance threshold device (ITD) and the ResQPOD is the only ITD availablein the US market. The AHA has said in its report that the use of the ITD has been shown to improve circulation during CPR and increase the return of spontaneous circulation (ROSC) in cardiac arrest patients. The Class IIa rating is the second highest rating possible and the ResQPOD is now more highly recommended by the AHA than any other device or drug used by emergency personnel for increasing circulation during CPR and improving resuscitation rates.

Advanced Circulatory System's ResQPOD uses proprietary new technology that increases circulation by regulating air flow into the lungs during the chest wall recoil (or decompression) phase of CPR. In multiple preclinical investigations and seven different published clinical studies with patients in cardiac arrest, the new device has been shown to dramatically and significantly increase blood return to the heart and blood flow to the vital organs during CPR. Cardiac arrest, even with CPR, results in a profound state of shock, and increasing blood flow until the heart can be restarted is critical to improving survival rates with good neurological function.

According to the AHA, more than 95% of the 350,000 Americans who die each year of cardiac arrest outside of the hospital die before they get to the hospital. Recent research has focused on how to increase survival rates through effective CPR in non-hospital settings. While not a panacea, the ResQPOD offers new hope to the millions of patients who suffer from a cardiac arrest worldwide each year.

The ResQPOD, introduced to the US market in 2004, is now used as a circulatory enhancer by hospital and EMS personnel throughout the US and internationally and is distributed by Tri-anim Health Services, Inc. (Sylmar,CA). Recently the ResQPOD was implemented by the EMS system in Collier County (Naples), Florida, and the early experience of the first three months has shown remarkably increased survival rates, according to the EMS system's Medical Director, Dr. Robert Tober.

Dr. Keith Lurie, Chief Medical Officer of Advanced Circulatory Systems said, "We are very pleased that the AHA has given this new device a high recommendation for use during CPR. Our goals and those of the AHA are linked: to improve survival rates of patients who experience cardiac arrest both inside and outside the hospital. Survival rates in these events have been dismal and we believe more can be done to improve them. It is gratifying to see the dramatic results that EMS rescuers are reporting back to us now that the device is becoming more widely used."

Advanced Circulatory Systems produces products to improve the outcomes of cardiac resuscitation, circulatory shock and head trauma. Advanced Circulatory System's technology may be used in any medical situation where an increase in circulation is of benefit, for example, cardiac arrest, blood loss, orthostatic hypotension, heat shock, and dialysis. For more information or to inquire about use of the ResQPOD, please contact Advanced Circulatory Systems at 952-947-9590 or 1-877-737-7763.

The generally cleared indication for the ResQPOD is a temporary increase in blood circulation during emergency care, hospital, clinic and home use. Studies are ongoing in the United States to evaluate the long-term benefit of the ResQPOD for indications related to patients suffering from cardiac arrest, hypotension during dialysis and severe blood loss. The references in this communication are not intended to imply specific outcome-based claims not yet cleared by the US Food and Drug Administration.

SOURCE Advanced Circulatory Systems, Inc.


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