Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1459-1461 , December 2009

Premarket assessment of devices for treatment of critical limb ischemia: The role of Objective Performance Criteria and Goals

  • Patrick J. Geraghty, MD

      Affiliations

    • Section of Vascular Surgery, Washington University School of Medicine, St. Louis, Mo
    • Corresponding Author InformationReprint requests: Patrick J. Geraghty, MD, Section of Vascular Surgery, Washington University School of Medicine, Saint Louis, MO
    • ,
  • Jon S. Matsumura, MD

      Affiliations

    • Division of Vascular Surgery at the University of Wisconsin-Madison, Madison, Wis
    • ,
  • Michael S. Conte, MD

      Affiliations

    • Division of Vascular and Endovascular Surgery at the University of California-San Francisco, San Francisco, Calif

Received 18 September 2009 ,Accepted 12 October 2009.

References 

  1. The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085994.htmAccessed June 15, 2009
  2. Chen E, Sapirstein W, Ahn C, Swain J, Zuckerman B. FDA perspective on clinical trial design for cardiovascular devices. Ann Thorac Surg. 2006;82:773–775
  3. Grunkemeier GL, Jin R, Starr A. Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial. Ann Thorac Surg. 2006;82:776–780
  4. Goode J, Sapirstein W, Zuckerman B. FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices. Catheter Cardiovasc Interv. 2007;69:920–921

 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.

PII: S0741-5214(09)02091-6

doi: 10.1016/j.jvs.2009.10.041

Journal of Vascular Surgery
Volume 50, Issue 6 , Pages 1459-1461 , December 2009

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