Premarket assessment of devices for treatment of critical limb ischemia: The role of Objective Performance Criteria and Goals
Received 18 September 2009; accepted 12 October 2009. published online 09 November 2009.
Medical devices are cleared for marketing approval through the Food and Drug Administration (FDA). Unique statutory requirements, such as the “least burdensome mandate,” have allowed the FDA to employ non-concurrent controls in its evaluation of prospective therapies. The use of Objective Performance Criteria and Goals (OPC and OPG) for the premarket evaluation of cardiovascular devices has become established as an alternative to randomized, controlled trials (RCTs). These single-armed comparisons may facilitate rapid entry of novel devices to the market. Unlike RCTs, they do not establish superiority or non-inferiority of the examined therapy, and study populations must be carefully inspected to ensure validity of comparisons to historical controls.
aSection of Vascular Surgery, Washington University School of Medicine, St. Louis, Mo
bDivision of Vascular Surgery at the University of Wisconsin-Madison, Madison, Wis
cDivision of Vascular and Endovascular Surgery at the University of California-San Francisco, San Francisco, Calif
Reprint requests: Patrick J. Geraghty, MD, Section of Vascular Surgery, Washington University School of Medicine, Saint Louis, MO
Competition of interest: Dr Geraghty has received consulting fees from W. L. Gore and Cook Medical. Dr Matsumura has received research support, consulting fees, and/or training director fees from Abbott, Bard, Cook Medical, Cordis, Ev3, W. L. Gore, Lumen, and Medtronic.
The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.
ABSTRACT