Author + information
- Received July 18, 2016
- Revision received September 6, 2016
- Accepted September 19, 2016
- Published online December 12, 2016.
- João Pedro Ferreira, MD, PhDa,
- Kevin Duarte, Msca,
- Todd L. Graves, PhDb,
- Michael R. Zile, MDc,
- William T. Abraham, MDd,
- Fred A. Weaver, MDe,
- JoAnn Lindenfeld, MDf and
- Faiez Zannad, MD, PhDa,∗ ()
- aINSERM, Centre d’Investigations Cliniques Plurithématique 1433, Université de Lorraine, CHRU de Nancy and F-CRIN INI-CRCT, Nancy, France
- bBerry Consultants LLC, Austin, Texas
- cMedical University of South Carolina and the RHJ Department of Veterans Affairs Medical Center, Charleston, South Carolina
- dOhio State University, Columbus, Ohio
- eDivision of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Southern California, Los Angeles, California
- fVanderbilt Heart and Vascular Institute, Nashville, Tennessee
- ↵∗Reprint requests and correspondence:
Dr. Faiez Zannad, Centre d'Investigation Clinique Inserm, CHU, Université de Lorraine, Institut Lorrain du Coeur et des Vaisseaux, 4, rue du Morvan, 54500 Vandoeuvre-Les-Nancy, France.
The Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions document was issued as a guidance for industry and for the Food and Drug Administration. The Expedited Access Pathway was designed as a new program for medical devices that demonstrated the potential to address unmet medical needs for life threatening or irreversibly debilitating conditions. The Food and Drug Administration would consider assessments of a device’s effect on intermediate endpoints that, when improving in a congruent fashion, are reasonably likely to predict clinical benefit. The purpose of this review is to provide evidence to support the use of 3 such intermediate endpoints: natriuretic peptides, such as N-terminal pro–B-type natriuretic peptide/B-type natriuretic peptide, the 6-min walk test distance, and health-related quality of life in heart failure.
Dr. Ferreira has received board membership fees from Novartis. Dr. Zile is a consultant to and receives research support from CVRx, Novartis, Abbott, and Medtronic. Dr. Abraham has received consulting fees and speaking honoraria from CVRx; and is member of the CVRx Heart Failure Executive Steering Committee. Dr. Weaver is a consultant to and receives research support from CVRx, WL Gore, and Endologix. Dr. Lindenfeld is a consultant to Novartis, CVRx, Abbott, St. Jude, Resmed, and Relyspsa; and receives research support from Novartis. Dr. Zannad is consultant to Boston Scientific, CVRx, AstraZeneca, Boehringer, Amgen, GE Healthcare, Quantum Genomics, Actelion, Bayer, Janssen, Resmed, Roche Diagnostics, Relypsa, ZS Pharma, Takeda, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 18, 2016.
- Revision received September 6, 2016.
- Accepted September 19, 2016.
- American College of Cardiology Foundation
- Central Illustration
- Natriuretic Peptides
- Heart Failure With Reduced Ejection Fraction
- Heart Failure With Preserved Ejection Fraction
- Acute Heart Failure
- NP Changes and Application in Trials
- Drop in NP Levels: How Much Is Clinically Meaningful?
- Increase in 6MWD: How Much Is Enough?
- Increase in QoL Parameters: How Much Is Enough?
- Practical Suggestions for Trials