Author Affiliations: Society of Thoracic Surgeons, Plano, Texas (Dr Mack); and American College of Cardiology, Rochester, Minneapolis (Dr Holmes).
Complex, high-risk medical devices ordinarily receive regulatory approval for use in clinical practice based on results from rigorous randomized controlled trials (RCTs). However, the trial results obtained in a specific population in select centers by expert health care teams and with limited long-term follow-up may not be generalizable in the “real-world setting.” To assess this latter issue, once the device is approved, the Food and Drug Administration (FDA) typically requires postmarketing surveillance studies to detect safety issues in the broader application of the device in expanded, community use.
Mack MJ, Holmes DR. Rational Dispersion for the Introduction of Transcatheter Valve Therapy. JAMA. 2011;306(19):2149–2150. doi:10.1001/jama.2011.1675