Mustapha, J. A.
Fisher, Bryan T. Sr.
Rizzo, John A.
Chen, Jie
Martinsen, Brad J.
Kotlarz, Harry
Ryan, Michael
Gunnarsson, Candace
Funding for this research was provided by:
Cardiovascular Systems, Inc.
Article History
Received: 24 March 2016
Accepted: 22 June 2016
First Online: 15 February 2017
Compliance with Ethical Standards
:
: This study was sponsored by Cardiovascular Systems, Inc. Dr. Mustapha reports personal fees from Cardiovascular Systems, Inc., outside the submitted work; Dr. Fisher reports paid consultant and registry participant to WL Gore and paid consultant and faculty member to Cardiovascular Systems, Inc., and Cordis. Dr Chen reports no conflict of interest. Dr. Martinsen and Mr. Kotlarz are employees of and own stock in Cardiovascular Systems, Inc., the study sponsor. Michael Ryan and Dr. Gunnarsson are employees of and Dr. Rizzo is a consultant to CTI Clinical Trial and Consulting Services, Inc., which is a paid consultant to Cardiovascular Systems, Inc., the study sponsor.
: This article does not contain any studies with human participants or animals performed by any of the authors. A protocol describing the study objectives, criteria for patient selection, data elements of interest, and statistical methods was submitted to the New England Institutional Review Board (NEIRB), and exemption was obtained (NEIRB Exemption No. 16-079).