Summary
Many antiarrhythmia devices are now either being marketed or are under clinical investigation in the United States. These devices include traditional pacing systems such as inhibited single and dual chamber pacemakers (AAI, WI, DVI and DDD) for the control of bradyarrhythmias and for overdrive suppression of certain tachyarrhythmias. The newer burst pacing systems and implantable cardioverters are being studied for control of both supraventricular and ventricular tachycardia and for control of ventricular tachycardia and fibrillation. To establish effectiveness, FDA requires that the manufacturer demonstrate that the pacing system provides the benefits claimed in the labeling. The data required to demonstrate the effectiveness for each of these types of pacing systems are discussed.
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References
Joint American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovascular Procedures (Subcommittee on Pacemaker Implantation): Guidelines for permanent cardiac pacemaker implantation. May 1984. JACC 4:434–442, 1984.
Griffin, JC: Recommendations of the NASPE policy conference on the clinical investigation of new implantable pacemakers. PACE 6: 159–160, 1983.
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© 1985 Martinus Nijhoff Publishing, Boston
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Rahmoeller, G.A. (1985). New Antiarrhythmia Devices — FDA’s Requirements for Effectiveness. In: Morganroth, J., Moore, E.N. (eds) Cardiac Arrhythmias: New Therapeutic Drugs and Devices. Developments in Cardiovascular Medicine, vol 47. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-2595-6_19
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DOI: https://doi.org/10.1007/978-1-4613-2595-6_19
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4612-9626-3
Online ISBN: 978-1-4613-2595-6
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