Heart1.com: Great Information, Real Community, Better Living.
 Register
 Login
 Main Page
 Heart News
Feature Story
 Education Center
Conditions
Procedures
Diagnostics
 Heart Attack Center
Prevention
Survivors
Dr. Tod Engelhardt  Heart
 Hero™

Dr. Tod Engelhardt:
Combating Major Blood Clots.
About Heroes
 Join the Discussion  in  Our Forums
 Community
Heart1 Forums
Patient Stories
 Reference
Online Resources
Video Library
advertisement
Search the Body1 Network
September 24, 2017  
HEART NEWS: Feature Story

  • Print this Article
  • Email this Article
  • Links/Reprints
  • Government Approves Wearable Defibrillator


    December 19, 2001
    By Associated Press
    December 19, 2001

    WASHINGTON — The government has approved the first wearable defibrillator, one people strap on under their clothes to zap their hearts out of lethal irregular rhythms — possibly helping 50,000 patients a year.

    The Lifecor Wearable Cardioverter Defibrillator is intended for people at risk of dying from sudden cardiac arrest while they are awaiting a heart transplant or right after they survive a heart attack.

    About 250,000 Americans die each year of cardiac arrest, which occurs when the heart suddenly quits pumping in an organized way, stopping blood circulation.

    Unless victims are quickly revived by an electrical shock to the heart, they soon die or suffer irreversible brain damage. For each minute that passes before a defibrillator shocks the heart back into a normal rhythm, the chance of surviving drops 10 percent.


    Some people at high risk of cardiac arrest have defibrillators surgically implanted in their chests. Others survive thanks to portable external defibrillators that bystanders can use when they collapse.


    The newly approved wearable defribillator can be worn close to the body, hidden beneath clothing. (Photo courtesy Lifecore, Inc.)
     

     

    The Food and Drug Administration approved Lifecor's wearable version Tuesday as an alternative to portable defibrillation for people who need only temporary help — while they're awaiting a transplant or until their heart recovers after a heart attack.

    ``It's user-friendly,' said FDA cardiovascular device chief Dr. Bram Zuckerman. ``It might have a significant impact,' helping 50,000 recovering heart-attack patients and another 1,000 people awaiting a new heart each year.

    The device resembles a fabric gun holster, strapped to the lower chest and over the shoulders. Four sensors measure heartbeat. They are wired to a battery-operated tiny defibrillator worn on the belt that sends a shock back to the heart when the sensors measure a lethal irregular heartbeat.

    In clinical trials, 289 heart patients in the United States and Europe wore the defibrillator 20 hours a day for three months. It was 71 percent successful in treating sudden cardiac arrest, compared to a 25 percent success rate when people call 911 for treatment, FDA officials concluded.

    The device failed to successfully treat two episodes of cardiac arrest because patients had incorrectly assembled the electrodes, but Lifecor subsequently changed the design to eliminate confusion, FDA said.

    Some 2 percent of patients experienced an unnecessary shock from the device, a rate similar to implantable defibrillators. The most frequent side effect was a temporary skin rash experienced by 5 percent of defibrillator wearers.

    The new defibrillator will be available early next year but only in limited numbers because Pittsburgh-based Lifecor is redesigning it to be even smaller, said vice president Kathy Higgs. Because patients will need it only temporarily, the company plans to rent it and currently is negotiating rental fees with Medicare and insurance companies, she said.

     

    Related web resources
    Lifecore wearable defribillator

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Last updated: 19-Dec-01

    Comments

  • Add Comment
  •    
    Interact on Heart1

    Discuss this topic with others.
     
    Feature Archives

    Heart Disease Patients Need to Exercise to Benefit from the Protective Effects of Wine

    Effective Treatment for Heart Failure Possible Following Discovery of Heart Molecule

    Significant Decrease in Heart Disease after Prison Smoking Bans

    Heart Failure Patients Who Sleep Poorly Are at Double the Risk for Hospitalization

    Long-Term Survival Possible for Pediatric Heart Transplant Patients

    Next 5 Features ...

    More Features ...
       
     
    Related Multimedia

    The risk of cardiac death due to a lower ejection fraction

    The function of a defibrillator

    Plaques/fatty deposits as a cause for a heart attack

    More Features ...
     
    Related Content
    Doctors Want Defibrillators in Homes

    Chaotic Heartbeats Seen in Winter

    Cardiac Ischemia

    Cardiac Arrest

    Sudden Cardiac Arrest

    More Features ...
     
    Home About Us Press Jobs Advertise With Us Contact Us
    advertisement
    © 2017 Body1 All rights reserved.
    Disclaimer: The information provided within this website is for educational purposes only and is not a substitute for consultation with your physician or healthcare provider. The opinions expressed herein are not necessarily those of the Owners and Sponsors of this site. By using this site you agree to indemnify, and hold the Owners and Sponsors harmless, from any disputes arising from content posted here-in.