Should Sham Control vs Open Trial Design Make a Difference for Device Regulators and Guideline Makers?

<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>Consultant Fee/Honoraria/Speaker’s Bureau - Valfix; TherOx; HeartFlow; Ablative Solutions; Neovasc; Ancora; RCE; Cardiac Success; Elucid Bio; Occlutech; HighLife; Apollo Therapeutics; Impulse Dynamics; Adona Medical; Oxitope; Aria; Elixir; Abbott</li><li>Equity/Stock(s)/Options - Ancora; Cagent; Applied Therapeutics; Biostar family of funds; SpectraWave; Orchestra Biomed; Aria; Valfix; Xenter; Cardiac Success</li><li>Grant Support/Research Contract - Abbott Vascular; Bioventrix; V-wave; Shockwave; Cardiovascular Systems Inc.; Phillips; Biosense Webster; Vascular Dynamics; Pulnovo; Abiomed</li><li>Consultant Fee/Honoraria/Speaker's Bureau - Alleviant; FBR Medical; Myochron; Colibri; Bioventrix; MedHub</li></ul>