Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program

Medicare’s National Coverage Determination for Aducanumab — A One-Off or a Pragmatic Path Forward?

(2022) Sanket S. Dhruva et al.   NEW ENGLAND JOURNAL OF MEDICINE

A Vision of Medicare Coverage for New and Emerging Technologies—A Consistent Process to Foster Innovation and Promote Value

(2022) Lee A. Fleisher et al.   JAMA Internal Medicine

Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown?

(2021) Vinay K. Rathi et al.   NEW ENGLAND JOURNAL OF MEDICINE

Absorbing the Aftershocks of a New Device for Coronary Calcification

(2021) Ajay J. Kirtane et al.   JACC-Cardiovascular Interventions

Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction

(2020) Michael R. Zile et al.   JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Early experience with the FDA’s Breakthrough Devices program

(2020) James L. Johnston et al.   NATURE BIOTECHNOLOGY

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease: The Disrupt CAD III Study

(2020) Jonathan M. Hill et al.   JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Evaluation of technologies approved for supplemental payments in the United States

(2019) Timothy J Judson et al.   BMJ-British Medical Journal

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation

(2018) William T. Abraham et al.   JACC-Heart Failure

Validation of Exercise Capacity as a Surrogate Endpoint in Exercise-Based Rehabilitation for Heart Failure

(2018) Oriana Ciani et al.   JACC-Heart Failure

Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016

(2018) Aliya C. Roginiel et al.   MEDICINE

Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation

(2016) Aaron S. Kesselheim et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

A Randomized Trial Testing US Food and Drug Administration “Breakthrough” Language

(2015) Tamar Krishnamurti et al.   JAMA Internal Medicine

Sham Controls in Medical Device Trials

(2014) Rita F. Redberg   NEW ENGLAND JOURNAL OF MEDICINE

2013 ACCF/AHA Guideline for the Management of Heart Failure: Executive Summary

(2013) Clyde W. Yancy et al.   CIRCULATION

A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure

(2011) Alan Kadish et al.   AMERICAN HEART JOURNAL