FDA approves new heart device to prevente sudden cardiac death.The US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approved the first implantable heart device intended to treat heart failure and prevent sudden cardiac death Sudden Cardiac Death Definition Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. . The CD/EasyTrak, manufactured by Guidant Corporation of Indianapolis, IN, is an implantable cardioverter defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. ) capable of detecting and resynchronizing abnormal heart rhythms by coordinating contractions of the right and left ventricles, thereby allowing the heart to pump blood more efficiently. In clinical trials, patients with the new device showed improvement in common symptoms of heart failure, such as fatigue and shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. . They also experienced enhanced exercise capacity compared to patients with standard ICDs that deliver an electrical shock to normalize heart rhythm. The CD/EasyTrak is intended only for the treatment of people in advanced heart failure who need an ICD, and whose heart timing is not synchronous despite taking anti-arrhythmia drugs, the FDA cautioned. Furthermore, because the submitted data did not show whether the device ultimately affected patient survival, the agency is requiring Guidant to conduct a post-marketing study of 1000 patients over the next 3 years to better assess long-term safety and the impact of the device on mortality. |
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