Medical Devices

Personalized Cardiac Therapies

Contact

Ksenia Blinova, Ph.D.
David Strauss, M.D., Ph.D.

Summary

This group performs regulatory science research to improve the prediction of which patients will benefit from heart devices and therapies and which patients are likely to be harmed.

Three major areas of application for this research are:

  1. defining better patient selection criteria for cardiac resynchronization therapy (a special pacemaker for patients with heart failure) and implantable defibrillators,
  2. developing and testing novel biomarkers for heart toxicity, and
  3. using patient-specific induced pluripotent stem cell derived cardiomyocytes to predict personalized response to drugs.
< Simulated electrocardiogram of left bundle branch block.

Simulation of a left bundle branch block case (impairment of the normal cardiac excitation pathway): anatomical model and corresponding electrocardiogram.


Calcium in a beating cardiomyocyte/

Intracellular calcium transients in contracting adult rabbit heart cell imaged with confocal microsopy.


Arrhythmias in induced pluripotent stem cell derived cardiomyocytes/

Arrhythmias detected in human induced pluripotent stem cell derived cardiomyocytes measured with a voltage-sensitive dye.

To this end, the group uses a translational medicine approach including:

  • whole heart and single cell cardiac models for medical devices safety and efficacy evaluation,
  • assessment of patient-specific induced pluripotent stem cell derived heart cells in precision medicine,
  • assessment of human induced pluripotent stem cell derived cardiomyocytes for evaluating drug-induced arrhythmias,
  • preclinical computational modeling/simulation,
  • patient studies to characterize individual patient characteristics,
  • individual-patient meta-analyses of clinical trials, and
  • post-market outcomes and comparative effectiveness research.

These diverse projects across different translational medicine areas are active collaborations with several researchers, both within the FDA and worldwide.

This research directly impacts the regulatory mission of the agency affecting:

  • FDA guidance documents and action plans,
  • acquired knowledge that supports pre-market submission reviews,
  • achieving the right balance between pre-market/post-market data collection,
  • disseminating science to improve the awareness of personalized medicine and facilitate innovative future products and methods,
  • development of new biomarkers, and
  • improvement of patient care in daily clinical settings.

Media Articles

Personnel

FDA Staff:
Ksenia Blinova, Ph.D.
David G. Strauss, M.D., Ph.D.
Dulciana Chan
Loriano Galeotti, Ph.D.
Richard Gray, Ph.D.
Jayna Stohlman

Research Fellows:
Meisam Hosseini
Lars Johannesen, Ph.D
Derek Schocken
Jose Vicente
Robbert Zusterzeel, M.D., Ph.D.

FDA collaborators

Daniel Canos
Thomas Colatsky
Sarah Dutta
Jeffry Florian
Christine Garnett
Danica Marinac-Dabic
Li Pang
Zhihua Li
Kathryn O’Callaghan
Ileana Pina
Kimberly Selzman
Norman Stockbridge
Wendy Wu

External collaborators

Johns Hopkins University
Duke University
Stanford University
University of Rochester
Yale School of Medicine
American College of Cardiology
University of Colorado
Centers for Medicare & Medicaid Services
Karolinska Institutet and Karolinska University Hospital
University of Zaragoza
Spaulding Clinical Research
Frontage Laboratories
Zenas Technologies
Cellular Dynamics International
Axiogenesis
Stem Cell Theranostics
Axion Biosystems
Clyde Biosciences
ACEA Biosciences

Resource facilities

Hardware 

  • Human induced pluripotent stem cells
  • Primary animal isolated heart cells
  • Perfused cardiac tissue/whole heart models
  • Optical recordings of membrane potential, intracellular calcium and contractions in monolayers and single cardiomyocytes
  • High-throughput microelectrode array recordings from cardiac cells
  • Electrical stimulation, pacing, defibrillation
  • Modeling and simulation of cardiomyocyte action potentials and electrocardiograms
Software
  • ECGLib / ECGLab

Relevant standards & guidance

Selected peer review publications

Page Last Updated: 08/09/2016
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