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The Food and Drug Administration and atrial defibrillation devices.
Am J Manag Care. 1999 Jul; 5(7):899-909.AJ

Abstract

CONTEXT

Atrial fibrillation is a common arrhythmia. It leads to significant morbidity and mortality, primarily from the increased incidence of stroke. The implantable atrial defibrillator, a new therapeutic option for the management of atrial fibrillation, is currently undergoing Food and Drug Administration (FDA) scrutiny for approval to market in the United States.

DATA SOURCES

A review of the basic epidemiology of atrial fibrillation, as well as the current status of accepted treatment options in light of the development of the implantable atrial defibrillator, was conducted. A literature search using the terms atrial fibrillation, implantable defibrillator, Food and Drug Administration, medical devices, and medical device regulatory law was conducted using the MEDLINE and Current Contents databases.

RESULTS

Currently, there is no consensus on the optimal treatment of atrial fibrillation. Despite the lack of definitive studies showing overall benefit associated with maintaining sinus rhythm in patients in atrial fibrillation, the implantable atrial defibrillator may soon reach the general market. We examine the FDA process for the evaluation of this new medical device and discuss implications for the patient, physician, industry, and health insurers.

CONCLUSIONS

Current FDA approval processes for new devices are a compromise between (a) the needs for expediency and encouraging innovation by the medical device industry and (b) the need to ensure that new devices will contribute to improved patient outcomes. We suggest alternative FDA-approval processes that address these issues.

Authors+Show Affiliations

Northwest Health Services Research and Development Field Program, VA Puget Sound Health Care System, Seattle, WA, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10557410

Citation

Chen, L, et al. "The Food and Drug Administration and Atrial Defibrillation Devices." The American Journal of Managed Care, vol. 5, no. 7, 1999, pp. 899-909.
Chen L, Keane AT, Every NR. The Food and Drug Administration and atrial defibrillation devices. Am J Manag Care. 1999;5(7):899-909.
Chen, L., Keane, A. T., & Every, N. R. (1999). The Food and Drug Administration and atrial defibrillation devices. The American Journal of Managed Care, 5(7), 899-909.
Chen L, Keane AT, Every NR. The Food and Drug Administration and Atrial Defibrillation Devices. Am J Manag Care. 1999;5(7):899-909. PubMed PMID: 10557410.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Food and Drug Administration and atrial defibrillation devices. AU - Chen,L, AU - Keane,A T, AU - Every,N R, PY - 1999/11/11/pubmed PY - 1999/11/11/medline PY - 1999/11/11/entrez SP - 899 EP - 909 JF - The American journal of managed care JO - Am J Manag Care VL - 5 IS - 7 N2 - CONTEXT: Atrial fibrillation is a common arrhythmia. It leads to significant morbidity and mortality, primarily from the increased incidence of stroke. The implantable atrial defibrillator, a new therapeutic option for the management of atrial fibrillation, is currently undergoing Food and Drug Administration (FDA) scrutiny for approval to market in the United States. DATA SOURCES: A review of the basic epidemiology of atrial fibrillation, as well as the current status of accepted treatment options in light of the development of the implantable atrial defibrillator, was conducted. A literature search using the terms atrial fibrillation, implantable defibrillator, Food and Drug Administration, medical devices, and medical device regulatory law was conducted using the MEDLINE and Current Contents databases. RESULTS: Currently, there is no consensus on the optimal treatment of atrial fibrillation. Despite the lack of definitive studies showing overall benefit associated with maintaining sinus rhythm in patients in atrial fibrillation, the implantable atrial defibrillator may soon reach the general market. We examine the FDA process for the evaluation of this new medical device and discuss implications for the patient, physician, industry, and health insurers. CONCLUSIONS: Current FDA approval processes for new devices are a compromise between (a) the needs for expediency and encouraging innovation by the medical device industry and (b) the need to ensure that new devices will contribute to improved patient outcomes. We suggest alternative FDA-approval processes that address these issues. SN - 1088-0224 UR - https://www.unboundmedicine.com/medline/citation/10557410/The_Food_and_Drug_Administration_and_atrial_defibrillation_devices_ L2 - https://www.ajmc.com/pubMed.php?pii=1260 DB - PRIME DP - Unbound Medicine ER -