Welcoming remarks

Donna Lochner, Food and Drug Administration (FDA)

Tim Baldwin, PhD, National Heart, Lung and Blood Institute (NHLBI)

Semahat Demir, PhD, National Science Foundation (NSF)

First session:Multi-scale modeling

Moderator – Vijaya Kolachalama, PhD

INVITED PLENARY PRESENTATION No. 1

MULTISCALE MODELING OF THE HUMAN ARTERIAL TREE
Professor George Karniadakis, PhD
Professor of Applied Mathematics, Brown University

FROM MECHANOBIOLOGY AND BIOMECHANICS TO MEDICAL DEVICE DESIGN: A NEW PARADIGM FOR MULTISCALE MODELING
Jay D Humphrey, PhD , CA Figueroa, PhD, S Baek, PhD, and CA Taylor, PhD

MULTI-SCALE MODEL OF BLOOD FLOW WITH APPLICATION TO HEMOTRAUMA
S Hund MS, R Zhao, PhD, T Phillips, MS, J Kim, G Miller, PhD, M Massoudi, PhD,
M Kameneva and James Antaki, PhD

MICROSTRUCTURE-BASED MODELING OF CONTROLLED RELEASE COATINGS
David M Saylor, PhD , CS Kim, PhD, DV Patwardhan, PhD, and JA Warren, PhD

SATURABLE DRUG BINDING EXPLAINS THE DOSE AND TISSUE DEPENDENCE OF STENT DELIVERY
Rami Tzafriri, PhD and ER Edelman, MD, PhD

Second session: Multi-scale modeling

Moderator – Tim Baldwin, PhD

INVITED PLENARY PRESENTATION No. 2

MULTI-SCALE MODELING IN CARDIOVASCULAR DEVICE DESIGN
Professor Andrew McCulloch, PhD
Professor of Bioengineering, University of California San Diego

NUMERICAL SIMULATIONS OF THE THREE-DIMENSIONAL PULSATILE HINGE FLOW FIELDS OF BILEAFLET MECHANICAL HEART VALVES
HA Simon MS, L Ge, PhD, LP Dasi, PhD, I Borazjani, PhD, HL Leo, PhD,
F Sotiropoulos, PhD, and Ajit P Yoganathan, PhD

HIGH RESOLUTION COMPUTATIONAL FRAMEWORK FOR PATIENT-SPECIFIC SIMULATIONS OF HEART VALVE PROSTHESIS
I Borazjani, PhD, T Le, and Fotis Sotiropoulos, PhD

CHARACTERIZING THE INFLUENCE OF SCAFFOLD ANISTROPY ON ENGINEERED HEART VALVE LEAFLET FUNCTION
David E Schmidt and MS Sacks

COMPUTATIONAL MODELING OF FLOW DISTURBANCES FROM CLOTS CAPTURED IN VENA CAVA FILTERS
James E Moore Jr, PhD , E Rahbar, and D Mori, PhD

Third session: Imaging for Cardiovascular Device Modeling 

Moderator – Tina Morrison, PhD

PATIENT-SPECIFIC COMPUTER MODELING OF MIGRATION FORCES ON THORACIC AORTIC STENT-GRAFTS
C Alberto Figueroa, PhD, CA Taylor, PhD, and CK Zarins, MD

SAFETY AND EFFICACY OF FLOW DIVERTING STENTS FOR INTRACRANIAL ANEURYSMS
Juan Cebral, PhD, R Löhner, PhD, and C Putman, MD

THREE-DIMENSIONAL MOTION COMPENSATED RECONSTRUCTION AND VISUALIZATION OF IMPLANTABLE CARDIAC DEVICES BASED ON ROTATIONAL X-RAY ANGIOGRAPHY
G Schoonenberg, MS, A Neubauer, PhD, J Chen, PhD, and John Carroll, MD

PRELIMINARY RESULTS OF FDA’s INTERLABORATORY ASSESSMENT OF COMPUTATIONAL FLUID DYNAMICS AND HEMOLYSIS IN MEDICAL DEVICES
Critical Path Initiative Sponsored Project
Sandy FC Stewart, GW Burgreen, EG Paterson, P Hariharan, M Giarra, V Reddy,
S Day, KB Manning, S Deutsch, MR Berman, MR Myers, and RA Malinauskas

Point - Counterpoint: Test to Failure versus Model to Failure 

Moderator: Charles Taylor, PhD

Point: Test to failure
Carl F. Popelar, PhD, Southwest Research Institute

Counterpoint: Model to failure
Kenneth Perry, PhD, ECHOBIO, LLC

Moderated panel discussion with speakers and two guests:
Alan Pelton, PhD, Nitinol Devices & Components
Maureen Dreher, PhD, FDA

Point – Counterpoint: Computational Models are most useful when they can be validated versus Computational models are most useful when they cannot be validated 

Moderator: Elazer Edelman, MD, PhD

Point: Computational models are most useful when they can be validated
Mike Berman, PhD, FDA

Counterpoint: Computational models are most useful when they cannot be validated
Christopher Zarins, MD, Stanford School of Medicine

Moderated panel discussion with speakers and two guests:
Mike Schendel, Medtronic Vascular, Inc
Robert Benkowski, MicroMed

8:00 – 8:15 

Welcoming remarks

Donna Lochner, FDA

Current Challenges and Future Possibilities at the FDA 

Moderator: Donna Lochner

REVOLUTIONIZING REGULATORY APPROVAL OF CARDIOVASCULAR DEVICES WITH COMPUTATIONAL MODELING
Tina Morrison, PhD and Vijaya Kolachalama, PhD

CARDIOVASCULAR DEVICES AND COMPUTATIONAL FLUID DYNAMICS
Mike Berman, PhD and Eric Chen

CARDIOVASCULAR DEVICES AND COMPUTATIONAL SOLID MECHANICS
Pharoah Garma and Tina Morrison, PhD

CURRENT CHALLENGES AND FUTURE POSSIBILITIES OF COMPUTATIONAL MODELING, AN FDA PERSPECTIVE
Erica Takai, PhD

Moderated FDA Panel Discussion
Moderator: Maureen Dreher
Panelists: Mike Berman, Eric Chen, Pharoah Garma, Tina Morrison, Erica Takai, Felipe Aguel, Jennifer Goode, Mark Fellman, Fernando Aguel

Regulatory Related Topics

Moderator: Felipe Aguel, PhD

THE ROLE OF FEA IN THE ENGINEERING OF IMPLANTABLE MEDICAL DEVICES
Kenneth Perry, PhD

FROM CARDIOVASCULAR DEVICE COMPUTER MODELING RESEARCH TO GUIDELINES, GUIDANCE DOCUMENTS AND STANDARDS
John C Muskivitch, PhD

VERIFICATION AND VALIDATION FOR COMPUTATIONAL SOLID MECHANICS AND APPLICATIONS TO MEDICAL DEVICES
Scott W Doebling, PhD, YD Zhao, PhD, and RL Crane, PE

ANALYSIS OF DEVICE SAFETY AND PERFORMANCE USING PROBABILISTIC METHODS
Ramesh Marrey, PhD, M Krever, R Burgermeister, and R Grishaber, PhD

COMPUTATIONAL FLUID DYNAMICS MODELING OF ARTIFICIAL HEART PUMPS: ASSESSMENT OF TECHNOLOGY READINESS AND GAPS
Eric Paterson Ph.D, R Medvitz, PhD, D Boger, N Yang, K Manning, PhD, S Deutsch, PhD, G Rosenberg, PhD W Weiss, and R Kunz, PhD

OPEN MEDSYSTEMS: OVERCOMING BARRIERS TO DEVICE MODELING WITH CROSS-DISCIPLINARY OPEN SOURCE COLLABORATION
Craig Bonsignore

AN IMAGE-BASED CARDIOVASCULAR AND PULMONARY COMPUTATIONAL MODEL REPOSITORY FOR BLOOD FLOW SIMULATION
NM Wilson, PhD, GD Rubin, MD, CK Zarins, MD, and Charles A Taylor, PhD

ROBUST SIMULATION OF IN VIVO TISSUE ELECTROPORATION
Greg W Burgreen PhD and JC Newman III, PhD

Q&A with speakers

Device-specific talks – Concurrent Session A
CIRCULATORY SUPPORT AND HEART VALVES 

FREQUENTLY ASKED QUESTIONS ON EVALUATION OF BLOOD TRAUMA
Marina V Kameneva

LATEST TECHNIQUES FOR USING CFD WITH BLOOD PUMP REFINEMENT
Robert Benkowski, K Oliphant, and R Wampler

OPTIMIZATION OF THROMBOGENIC PERFORMANCE IN BLOOD RECIRCULATING DEVICES
Danny Bluestein, PhD, M Xenos, PhD, G Girdhard, PhD, J Sheriff, MS, T Claiborne, MS, Y Alemu, MS, S Einav, PhD, and J Jesty, PhD

INTEGRATING IN VITRO FLOW EXPERIMENTS AND COMPUTATIONAL FLUID DYNAMICS TO PREVENT THROMBOSIS IN BLOOD PUMPS
Keefe B Manning, PhD, V Reddy, BN Roszelle, BT Cooper, R Medvitz, PhD , S Deutsch, PhD, and E Paterson, PhD

Break

MULTISCALE STRUCTURAL ANALYSIS OF NATIVE AORTIC HEART VALVES
Hee Sun Kim, R Haj-Ali, PhD, CH Yap, L Dasi, Ph. D., and AP Yoganathan, PhD

EXPERIMENTAL REQUIREMENTS FOR VALIDATING HIGH RESOLUTION FSI-CFD TOOLS FOR HEART VALVE MODELING
Lakshmi P Dasi, PhD, L Ge PhD, I Borazjani, HA Simon F Sotiropoulos, PhD, and AP Yoganathan, PhD

PATIENT-SPECIFIC PERCUTANEOUS VALVE IMPLANTATION
Silvia Schievano, PhD, C Capelli, MEng, AM Taylor, MD MRCP FRCR, and
P Bonhoeffer, MD

Device-specific talks – Concurrent Session B
STENTS AND ENDOVASCULAR GRAFTS 

PLAIN RADIOGRAPHY AND COMPUTED TOMOGRAPY IN EVALUATION
OF THE FEMOROPOPLITEAL STENTS DEFORMATIONS
Alexander Nikanorov MD, PhD, M Schillinger MD, H Zhao PhD, and LB Schwartz MD

DEVELOPMENT OF A CONSTITUTIVE RELATION FOR MP35N ALLOYS
Paul H Adler, PhD

USE OF CLINICAL IMAGING IN THE DESIGN AND EVALUATION OF
ENDOVASCULAR STENT GRAFTS
Sam Robaina, S Varahoor PhD, A Gupta, and B Wolf

EFFECT OF CURVATURE ON MIGRATION FORCES ACTING ON ABDOMINAL AORTIC STENT-GRAFTS
C Alberto Figueroa, PhD, CA Taylor, PhD, and CK Zarins, MD

Break

RAPID AND COMPUTATIONALLY INEXPENSIVE QUANTIFICATION OF
HEMODYNAMIC ALTERATIONS INTRODUCED BY COMMERCIALLYAVAILABLE AND NEXT-GENERATION STENTS
TJ Gundert, AR Williams, MS, and John F LaDisa, Jr, PhD

INVESTIGATION OF ILIAC STRAIGHTENING FOR SIMULATED USE FLOW MODELS USING FINITE ELEMENT ANALYSIS
Atul Gupta, S Varahoor, PhD, and B Wolf

QUANTIFICATION OF BIFURCATIONS IN THREE-DIMENSIONAL CORONARY ARTERIAL TREE OF HUMAN
S James Chen Ph.D and JD Carroll, MD

QUANTIFICATION OF CORONARY ARTERY DYNAMICS FROM CARDIAC-GATED COMPUTED TOMOGRAPHY DATA
Gilwoo Choi, MS, G Xiong, MS, and CA Taylor, PhD

CORONARY STENT FRACTURES IN THE DRUG ELUTING STENT ERA:
A COMPREHENSIVE REVIEW
Chad Abunassar, MS and S Prabhu, PhD

OPTIMIZING DES USE IN BIFURCATION LESIONS: IMPORTANCE OF IN SILICO MODELING
Vijaya B Kolachalama, PhD and ER Edelman, MD, PhD

DEPLOYMENT MECHANICS OF A BIOABSORBABLE CORONARY
SCAFFOLD
Wayne M Falk, PhD, J Bergstrom, PhD, and V Giddings, PhD