Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 68, Issue 24, Pages 2690-2707Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2016.09.936
Keywords
heart failure trials; natriuretic peptides; surrogate endpoints
Categories
Funding
- Novartis
- CVRx
- Abbott
- Medtronic
- WL Gore
- Endologix
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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. (C) 2016 by the American College of Cardiology Foundation.
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