Real World Databases: What Is Required for Their Use To Substitute for Randomized Trials for Device Approvals, Reimbursement and Label Expansion

<p>Within the prior 24 months, I have had a financial relationship with a company producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: </p><ul><li>Grant Support/Research Contract - Abbott Vascular; Boston Scientific Corporation; Medtronic; Edwards Lifesciences; Elixir; JenaValve; Siemens</li><li>Consultant Fee/Honoraria/Speaker’s Bureau - Boston Scientific Corporation; Shockwave Medical; Edwards Lifesciences; JenaValve; Magenta Medical; Centers for Medicare and Medicaid Services</li><li>Consultant Fee/Honoraria/Speaker's Bureau - Cathworks; Elixir; Abbott; Medtronic</li><li>Industry Salary/Salary Support/Employee (full time or part time) - Special Government Employee, US Food and Drug Administration</li></ul>