CLINICAL RESEARCH: COST EFFECTIVENESS AND REGULATORY CONSIDERATIONS
Cardiac Resynchronization Devices
The Food and Drug Administration’s Regulatory Considerations
Megan Moynahan, MS*,
Owen P. Faris, PhD and
Brian M. Lewis, MD
Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland
Manuscript received April 13, 2005;
accepted May 4, 2005.
* Reprint requests and correspondence: Ms. Megan Moynahan, Chief, Pacing Defibrillators and Leads Branch, Office of Device Evaluation, U.S. Food and Drug Administration, 9200 Corporate Boulevard, HFZ 450, Rockville, Maryland 20850 (Email: megan.moynahan{at}fda.hhs.gov).
Cardiac resynchronization therapy (CRT) devices have been studied clinically since 1998, and have been on the U.S. market since the Food and Drug Administration (FDA) approval of the first product in 2001. Since that time, the FDA has approved many different models from three different manufacturers, representing the first and second generations of these products. All of these products have undergone the FDA pre-market approval process, which examines the safety and effectiveness of the devices for their intended use. Over the last several years, the FDA has adapted recommendations for CRT clinical trials based on an evolving understanding of what these devices can achieve. This paper will outline the dynamic nature of the FDA’s approval process for CRT devices and briefly review the clinical trial designs for the first generation devices.
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Abbreviations and Acronyms
| | CRT = cardiac resynchronization therapy | | EF = ejection fraction | | FDA = Food and Drug Administration | | ICD = implantable cardioverter-defibrillator | | LV = left ventricular | | NYHA = New York Heart Association |
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