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Medical Devices

FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, June 10-11, 2010: The integration of nonclinical and computer models

Date, Time and Location

The meeting will be held on June 10 and 11, 2010 from 8:00 a.m. to 5:00 p.m. and an optional session (see agenda) will be held on June 9, 2010 from 1:00 p.m. – 5:30 p.m. at the following location:

Hilton Washington DC/ Rockville
Executive Meeting Center
1750 Rockville Pike
Rockville, MD 20852

The Hilton Washington DC/Rockville Hotel & Executive Meeting Center is the host hotel for this meeting. A block of rooms has been reserved for June 8–June 11, 2009, at the rate of $226.00 per night plus tax (15% for single/double occupancy). This is the Government rate for this area.

The deadline for making reservations at the Hilton Washington DC/Rockville Hotel is May 17, 2010. After May 17 room reservations will be made on a space-available basis. The number of available rooms is limited, so make your reservation early.

To make a hotel reservation, visit the Hilton’s online reservations system or call 1-800-HILTONS (445-8667). Be sure to reference the group code “FDA/CDRH” in order to obtain the group rate.

When reservations are made, the hotel requires a deposit equal to the room and tax of the first night for each reservation. This deposit is refundable if cancellation is received at least 24 hours prior to scheduled arrival.

You will be responsible for settling all charges before checking out of the hotel. Check-in is anytime after 4:00 p.m. and checkout is by 12:00 noon on your scheduled day of departure. A major credit card must be presented at the Front Desk upon arrival to secure incidental charges.

Lodging Cancellation Policy

If you need to cancel your reservation, please contact the hotel directly no later than 6:00 p.m., 24 hours in advance of your arrival date. All guests canceling reservations after 6:00 p.m. and less than 24 hours prior to the scheduled arrival date will incur a direct credit card charge of 1 night's lodging. If you cancel your reservation, be sure to obtain a cancellation number from the reservation agent for your records.

Agenda (preliminary)

(Optional session) Wednesday June 9, 2010

1:00-5:30 FDA Microstructure Modeling Session
Dinesh Patwardhan and David Saylor
The goal of this session is to introduce participants to microstructure-based models and their potential application in cardiovascular devices. This session was motivated by expressed interest in diffuse-interface models developed at the FDA for microstructure formation during the fabrication of controlled drug release coatings and the impact of that microstructure on the subsequent release response with specific emphasis on drug-eluting stents. Thus, the primary focus will be on these types of models for microstructure evolution. We plan to hold a series of invited lectures covering topics that include: the fundamental theory behind diffuse-interface models, numerical approaches and software to solve systems of equations based on the underlying theory, the specific models developed at the FDA, and potential extensions and applications of these models. We will close out the symposium with discussion aimed at getting feedback from participants. We would like to assess 1) the perceived utility of the models developed at the FDA, 2) optimum ways those interested could implement the model, and 3) whether there are other cardiovascular device areas where this type of approach would be beneficial. 
1:00-1:10 Welcoming remarks
Dinesh Patwardhan, Food and Drug Administration
1:10-1:50 James Warren, National Institute of Science and Technology
Diffuse-Interface Models for Microstructure Evolution
1:50-2:30 Jonathan Guyer, National Institute of Science and Technology
Obtaining Numerical Solutions to Diffuse Interface Problems with FiPy
2:30-2:40 Break
2:40-3:20 David Saylor, Food and Drug Administration
Predicting Microstructure Evolution in Controlled Drug Release Coatings
3:20-4:00 Klaus Wormuth, Surmodics, Inc.
Characterization of Thin Amorphous Drug Eluting Coatings
4:00-4:10 Break
4:10-4:30 Ismail Guler, Boston Scientific Corporation
Application of Dissolution-Diffusion Models and Effective Parameter Approaches to Describe Drug Release Kinetics of Drug-Eluting Stents
4:30-4:50 Vipul Dave, Cordis Corporation
Effect of Microstructure on Drug Delivery from Bioabsorbable Polymer Systems
4:50-5:10 Syed Hossainy, Abbott Vascular
Predictive Modeling of Drug release from a Drug Eluting Stent
5:10-5:30 Panel Discussion

Thursday, June 10, 2010

8:00-8:30 Registration and continental breakfast
8:30-8:45 Welcoming remarks
Donna Lochner, Food and Drug Administration
Timothy Baldwin, National Heart Lung and Blood Institute
8:45-9:30 Invited speaker - Philipp Bonhoeffer
The Role of Finite Element Analysis in the Approval of Transcatheter Pulmonary Valve
9:35-10:20 Session I: Integrative Methods for Device Evaluation
Juan R. Cebral; Identifying possible failure modes of flow diverting devices for intracranial aneurysms
Vijaya Kolachalama; Stent distensibility and arterial drug distribution: importance of integrative modeling approaches
Claudio Capelli; Stent-grafts for percutaneous pulmonary valve implantation: a patient-specific computational modeling approach
10:20-10:40 Networking Break
10:40-11:25 Session I - continued
L. Alberto Figueroa; Combining computational and medical imaging tools to evaluate the stability of aortic grafts
Alison Marsden; Optimal design and uncertainty quantification in blood flow simulation in congenital heart disease
Chad Abunassar; Integration of finite element analysis with bench testing: model correlation and validation
11:25-11:45 Discussion for Session I, led by moderator
11:45-12:30 Session II: Nonclinical Model Development
Novel materials for vascular devices
James E. Moore, Jr.; Modeling of biodegradable stents subjected to physiologic loading
Virginia Giddings; Computational model development of a bioresorbable vascular scaffold
Michael S. Sacks; A micro-architectural based structural model for elastomeric electrospun scaffolds for heart valve tissue engineering
Nuno Rebelo; On modeling assumptions of Finite Element Analysis of stents
Discussion led by moderator
12:30-1:45 Buffet Lunch in Hotel
1:45-3:00 Panel Discussion - Industry and Computational Modeling
Moderators: Elazer Edelman and Charles Taylor
Philipp Bonhoeffer, Great Ormond Street Hospital for Children
John Carroll, University of Colorado
Eitan Konstantino, TriReme Medical, Inc.
Richard Kuntz, Medtronic, Inc.
Robert Whirley, TriVascular, Inc.
3:00-3:20 Networking Break

Session II-Nonclinical Model Development - continued
Multi-Scale and Multi-Phase Modeling 
Danny Bluestein; Optimizing the thromboresistance of mechanical circulatory support devices and prosthetic heart valves
Bruce Caswell; Mesoscopic simulations of blood flow through a constriction 
M. Ertan Taskin; Evaluation of power-law hemolysis prediction models
Yoram Vodovotz; Agent-based simulation of arterial restenosis 
Rami Tzafriri; Computational model predicts multi-phasic drug elution kinetics from bulk degrading inlays in stent reservoirs

Discussion led by moderator

4:10-5:05 Session III: Evaluation of Cardiovascular Devices and their Environment
Jeongho Kim; Simulation-based automatic optimization of the Pediaflow™ VAD
Peter Mortier; Novel technique for the quantitative analysis of wall coverage of deployed stents: comparison of five stents
Wei Sun; Biomechanics and modeling of transcatheter valve intervention
Anamika Prasad; Evaluating the risk of aortic endograft migration using iterative-fluid-structural coupling
Michael A. Singer; Understanding the significance of renal inflow on the hemodynamics of vena cava filters
Discussion led by moderator
5:15-6:30 Poster session and reception

Friday, June 11, 2010

8:00-8:30 Registration and continental breakfast
8:30-8:40 Welcoming remarks
8:40-9:20 Session IV: Preclinical Tools and Computer Modeling
A) Image-based Research
John F. LaDisa, Jr.; Image-based quantification of 3D morphology for bifurcations in the left coronary artery: application to stent design
S. James Chen; Performance assessment of implanted device for transcatheter mitral valve repair based on three- dimensional modeling
Abhay A. Divekar; Analysis of real time in-vivo Amplatzer septal occluder deformation
John W. Karanian; Characterization of vascular implant sites by localized quantitative mapping of vascular geometry
Discussion led by moderator

B) Emerging Modeling Techniques 
Fotis Sotiropoulos; Evaluating operative scenarios of aortic mechanical heart valve (BMHV) implantation using CFD
Lewis Waldman; Computational modeling of heart failure therapies
Richard L. Summers; Use of a complex computer model of human cardiovascular physiology for guiding clinical trial design in the development of a telemetric intracardiac pressure monitoring device

9:45-10:05 Networking Break
10:05-10:50 Session IV: Preclinical Tools and Computer Modeling - continued
B) Emerging Modeling Techniques - continued
Greg W. Burgreen; Emerging trends toward moving boundary and dynamic mesh computation fluid dynamics
Iacovos Kyprianou; Virtual cardiac angiography room for computational clinical trials
Discussion led by moderator
10:50-11:40 Session V: Methods for Improving Device Outcomes
John C. Muskivitch; Developing a standard set of test problems for the validation of finite element models of cardiovascular stents
Sandy F.C. Stewart; FDA's interlaboratory computational study of flow in a nozzle model: using experimental results to refine simulations
Sanjeev Kulkarni; FEA and experimental comparison of radial force measurement for stents
Xiao-Yan Gong; Comparison of fatigue stress/strain computation methods
Samuel Hund; Analyzing curriculum in biomedical engineering to improve simulation outcomes
Discussion led by moderator
11:45-1:00 Buffet Lunch in Hotel
1:00-2:00 Session VI: FDA/Division of Cardiovascular Devices (DCD) Session
Tina Morrison;  Using Finite Element Analysis to support your device submission

Presentation followed by FDA Discussion-Future of FEA in DCD
Maureen Dreher, Office of Science and Engineering Labs
Nicole Ibrahim, Office of Device Evaluation
Srinidhi Nagaraja, Office of Science and Engineering Labs
Erica Takia, Office of Device Evaluation
Changfu Wu, Office of Device Evaluation

Panel Discussion-Research and Collaboration Policy Issues
Donna Lochner and Tina Morrison

Craig Bonsignore, NDC
John Carroll, University of Colorado
Isaac Chang, Food and Drug Administration
Lisa Lim, Food and Drug Administration
Nathan Wilson, Open Source Medical Software Corporation

3:00-3:20 Networking Break
3:20-4:45 Brainstorming Session / Closing Remarks
Moderated by the Workshop Organizing Committee


Registration for this workshop is being managed by Stanford Professional Development Center. Register online by clicking the link below:

The registration fee is $350 and includes lunch on June 10 and 11 and the reception on June 10. It also includes the optional FDA microstructure modeling session on June 9, should you choose to register for that session. If you have any questions regarding registration, contact Stanford Professional Development Center’s logistics coordinator, Robert Katayama via e-mail at or phone at 650-862-3553.


The workshop organizers may be contacted at:

Donna R. Lochner
Deputy Director
Division of Cardiovascular Devices
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-6309
Fax: (301) 847-8114

Charles A. Taylor, Ph.D.
Associate Chair for Undergraduate Education, Department of Bioengineering
Associate Professor of Bioengineering & Surgery
Stanford University
James H. Clark Center,
Room E350B
318 Campus Drive
Stanford, CA 94305-5431
Phone: (650) 725-6128
Fax: (650) 725-9082

J. Timothy Baldwin, Ph.D.
Program Director
Advanced Technologies & Surgery Branch
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Centre, Room 8206
6701 Rockledge Drive
Bethesda, MD 20892-7940
Phone: (301) 435-0513
Fax: (301) 480-1335

Semahat S. Demir, Ph.D.
Program Director, Biomedical Engineering
Engineering Directorate
The National Science Foundation
4201 Wilson Boulevard Arlington, Virginia 22230, USA
Tel: (703) 292-5111, FIRS: (800) 877-8339 | TDD: (800) 281-8749

Elazer R. Edelman, M.D., Ph.D.
Professor of Health Sciences and Technology,
Massachusetts Institute of Technology,
Brigham and Women’s Hospital
77 Massachusetts Avenue
Building E25-438
Cambridge, MA 02139
Phone: (617) 253-1569
Fax: (617) 253-2514

Laurence W. Grossman, Ph.D.
Division of Solid and Fluid Mechanics
Food and Drug Administration
10903 New Hampshire
Silver Spring, MD 20993
Phone: (301) 796-2502
Fax: (301)796-9934

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