Cardiac Resynchronization Devices

• Published in: Journal of the American College of Cardiology Vol. 46; no. 12; pp. 2325 - 2328
• Main Authors: Moynahan, Megan, Faris, Owen P., Lewis, Brian M.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 20-12-2005
• Subjects: NYHA; EF; FDA; LV; ICD; CRT
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2005.04.068

Cardiac Resynchronization Devices: The Food and Drug Administration’s Regulatory Considerations
Megan Moynahan, Owen P. Faris, Brian M. Lewis
Cardiac resynchronization therapy (CRT) devices marketed in the U.S. undergo the Food and Drug Administration’s (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 that support pre-market approval, based on an evolving understanding of what these devices can achieve. This paper outlines the dynamic nature of the FDA’s approval process for CRT devices and briefly reviews the clinical trial designs for the first generation devices.
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.