Back  |
-
Subscribe to newsletter
 News
-
Get listed our directory
Pharmaceutical Research Centers
Jordan's Associations
Dental Laboratories
Nursing Centers
Medical Centers
Fitness Centers
Beauty Centers
Optic Centers
Drugstores
Hospitals
Doctors
Dentists
Dietitian
Companies
Pharmacies
Dental Centers
Herbal Centers
Scientific Offices
Infertility Centers
Dead Sea Factories
Medical Laboratories
Pharmaceutical Factories
FDA APPROVES NEW WEARABLE DEFIBRILLATOR
FOR SERIOUSLY ILL HEART PATIENTS.....

The Food and Drug Administration today approved a vest-like medical device that is worn under clothing to monitor and treat abnormal heart rhythms in people at risk of dying from sudden cardiac arrest.

The product, made by Lifecor, Inc., of Pittsburgh, Pa., is the first cardioverter defibrillator that can be worn outside the body, rather than implanted in the chest.

The device is a programmable system that senses heart function and automatically delivers an electrical shock when needed to restore normal heart rhythm.

Until now, people who needed a cardioverter defibrillator had to have it surgically implanted into their chest.

"Today's approval represents a significant advance in defibrillator technology. It means patients may now opt for a wearable defibrillator if they are not suitable candidates for an implanted defibrillator or do not want one," said FDA Acting Principal Deputy Commissioner Bernard A. Schwetz, D.V.M., Ph.D.

The new product consists of an electrode belt assembly that is worn around the chest, touching the skin. It is connected to a monitor, with an alarm, that is worn in a holster at the waist. This entire device assembly is worn continuously 24 hours a day, except when the wearer is bathing or showering.

The device continuously monitors the patient's heart to detect life-threatening abnormal heart rhythms. Typically, once a week the physician will want the patient to connect the monitor to an external modem and send the data over the phone to the physician's computer for his review.

The defibrillator detects abnormal heart rhythms by sensing the heart's electrical activity on the surface of the chest. If a life-threatening rhythm is detected and the person loses consciousness, the device delivers an electrical shock to restore normal rhythm.

FDA approved the wearable defibrillator based on a review of laboratory and animal tests and clinical studies of safety and effectiveness conducted by Lifecor.

Some 289 heart patients at 16 medical centers in the United States and Europe were fitted with the defibrillator vest. All were either awaiting heart transplants or had recently had a heart attack or a coronary bypass operation. The patients wore the defibrillator for an average of 20 hours a day for approximately three months.

The wearable defibrillator was 71 percent successful in treating sudden cardiac arrest episodes compared to 25 percent success for patients calling 911. It successfully detected and treated five episodes of sudden cardiac arrest, and detected but was unable to treat two other episodes. The two failures to treat resulted because the patients had incorrectly assembled the electrodes in the vest. Lifecor subsequently changed the design of the garment to make it more user-friendly.

Two percent of patients experienced an unnecessary shock from the wearable device, compared to 2.3 percent false shocks per patient-month received by patients with an implantable defibrillator. Lifecor subsequently modified the device to further reduce the rate of unnecessary shocks.

The most frequent side effect was a temporary skin rash, experienced by 5.9 percent of study patients.

 

Published on 11 January 2002
 
 
  Are You interested to promote your self @ Yemen, Bahrain, Sudan, Libya & Arbeel?
  Severe stress in pregnancy may affect fetal growth
  Weight loss may cut risk of colorectal growths
  Flu shot does not cut risk of death in elderly
  Low Levels of Brain Chemical May Control Appetite
  Most Patients With Irregular Heartbeat Take Inadequate Blood Thinner Dose
  Wearing an underwire bra increases your risk of getting breast cancer
  Businesswomen from Uganda and Ghana were second and third as Jordanian entrepreneur takes first prize at UNCTAD’s debut women in business awards
  Jordanian Woman Wins First Prize: Sana Burgan
  "Concept, Indication and Handling of the Friadent Implant System Xive" courses will be held in Jordan Soon

  Dr. Joudeh Operated on a big Tumor.....

  HealLand Newspaper
  HealLand Jordan Directory
  Happy Eid
  Are You Targeting Jordan, Yemen, Bahrain and All the Arabic World
  Afurnished Clinic 4 Rent..

  Med Grant Est. launched it's 2nd edition of HealLand Jordan book.

  On the occasion of The New Year, Johealth seize this......
  Watch Us Today 8th of Sep. On Jordan TV @ 5:40
  HealLand Jordan 2nd Edition
  During menopause, estrogen levels go down. At the same time, bone breakdown (resorption) may increase.
  A Star Sent From Heaven to Dr. Samer Sunna - A Girl

  Dr. Sana Hammouri the First and Only Jordanian Female General Surgeon in the private sector

  Dr. Disi, One of the pioneer Orthopeadics doctors in Jordan

  Sabarini Consultation & Training Est. Offers a lot of services

  For Sale.... Siemens Sonoline SX Sector Ultrasound Scanning Machine

  NEW YORK (Reuters Health) - Older people who exercise are less likely to be depressed,
  LabTechONE is now a client of mayo Medical Laboratories and will provide comprehensive laboratory services
  Chicco, the Italian firm as we all know, is one of the most famous brands world wide....
  JOHEALTH has moved !

  Rheumatoid Arthritis Treatment: The FDA has approved anakinra as adjunctive therapy for..
  FDA APPROVES NEW WEARABLE DEFIBRILLATOR
FOR SERIOUSLY ILL HEART PATIENTS.....
  Breast Tissue Ablation Device: The FDA has approved Cryocare Surgical System....
  Drug for Severe Adult Sepsis: The FDA has approved drotrecogin alfa (activated)...
  On the occasion of Ramadan, Johealth seize this......

  Dr. Najib Layyous, One of the most pioner doctors in Jordan specialized in Infertility...
  Under the unprecedented support of his Royal Majesty King Abdullah II, to further promote the use of internet services for the benefit of the Jordanian people
  A Jordanian Pediatrician invents the first Natural Anti Diarrhea Medication for babies, children and adults.
  FDA issues nationwide alert on the recall of "PIERRE FABRE physicians formula eye makeup remover lotion" because of health risk.
  FDA Approves First Pacemaker For Congestive Heart Failure
  FDA updates safety information for MICONAZOLE VAGINAL cream and suppositories
Copyright © 2000-2018 JoHealth. All rights reserved
info@johealth.com

Powered by Softimpact