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FDA > CDRH > Office of Device Evaluation > FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008

FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008

Department of Health and Human Services, National Institutes of health: National Heart Lung and Blood Institute, People science health. National Science Foundation: Where discoveries begin

Date, Time and Location

The meeting was held on March 18, 2008 from 8 a.m. to 6:30 p.m. and on March 19, 2008 from 8 a.m. to 1:30 p.m. at the following location:

Bethesda Marriott
5151 Pooks Hill Road
Bethesda, Maryland 20814

301-897-9400

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Agenda and Videos

(Note: All video links are in Windows Media Format intended for broadband connections. Captioning is available.)

Tuesday, March 18, 2008

8:00-8:15am Welcoming remarks (Bram Zuckerman, FDA; Tim Baldwin, NIH; Semahat Demir, NSF)
8:15-8:30am Overview of Program, Discussion of Goals for Meeting (Charles Taylor, Stanford University)

Session 1 – Best Practices in Computational Mechanics

8:30-9:30am Simulation-Based Engineering Science (Thomas J.R. Hughes, University of Texas)
9:30-10:00am Computational Fluid Dynamics (Rainald Löhner, George Mason University)
10:00-10:30am Break
10:30-11:00am Computational Solid Mechanics (Jacob Fish, Rensselaer Polytechnic Institute)
11:00-11:30am Fluid-Solid Interactions (Klaus Jurgen Bathe, M.I.T.)
11:30-12:00pm Verification & Validation (Marty Pilch, Sandia Labs)
12noon-1pm Lunch Break

Session 2 – Best Practices in Cardiovascular Mechanics

1:00-1:20pm Cardiac Mechanics (Natalia Trayanova, Johns Hopkins University)
1:20-1:40pm Cardiac Fluid Dynamics (Charles Peskin, Courant Institute, N.Y.U.)
1:40-2:00pm Blood Flow in Arteries (Charles Taylor, Stanford University)
2:00-2:20pm Vessel Wall Mechanics, Growth and Remodeling (Jay Humphrey, Texas A&M)
2:20-2:40pm Thrombosis (Aaron Fogelman, University of Utah)
2:40-3:00pm Drug Transport in Artery Walls (Elazar Edelman, M.I.T.)
3:00-3:30pm Coffee Break

Session 3 – Barriers to Cardiovascular Device Modeling

3:30-3:45pm Stents (Brian Berg, Boston Scientific)
3:45-4:00pm Drug Eluting Stents (Santosh Prabhu, Abbott Vascular)
4:00-4:15pm Stent Grafts (Robert Whirley, Trivascular)
4:15-4:30pm Artificial Heart Valves (Hengchu Cao, Edwards Life Sciences)
4:30-4:45pm Ventricular Assist Devices (Bob Benkowski, MicroMed)
4:45-5:00pm Cardiac Rhythm Management (Mike Schendel, Medtronic)

Session 4 – Regulatory Perspectives

5:00-5:15pm Overview of Regulatory Best Practices (Sandy Stewart, FDA)
5:15-5:45pm Case studies: Regulatory Best Practices
Flow Visualization Round Robin Testing - a Critical Path Study (Richard Malinauskas, FDA)
Computational Modeling of Electrical Impulse Propagation during Fibrillation (Richard Gray, FDA)
Computational Modeling of Microstructure Development and Release Kinetics in Drug Eluting Coatings (David Saylor, FDA)
5:45-6:30pm Panel Discussion: Regulatory Issues Related to CV Device Modeling (FDA)
Dinner 7:00pm Critical Path Initiative at FDA (Dan Schultz)

Wednesday, March 19, 2008

8:00-8:15am Assignments for Breakout Session 1
8:15-9:15am Breakout Session 1 – What data/tools are needed to improve CV device modeling?
9:15-10:00am Reports of Breakout Groups
10:00-10:15am Assignments for Breakout Session 2
10:15-11:15am Breakout Session 2 – What are the respective roles of device companies, engineering software companies, academic institutions and government agencies in developing better tools for CV device modeling?
11:15-12noon Reports of Breakout Groups
12:00-12:30pm Closure of Meeting & Plans for the Future
12:30-1:30pm Lunch

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Contacts

The workshop organizers may be contacted at:

Charles A. Taylor, Ph.D.
Associate Professor of Bioengineering
Stanford University
James H. Clark Center,
Room E350B
318 Campus Drive
Stanford, CA 94305-5431
Phone: (650) 725-6128
Fax: (650) 725-9082
e-mail: taylorca@stanford.edu

Donna R. Lochner
Deputy Director
Division of Cardiovascular Devices
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: (240) 276-4043
Fax: (240) 276-4002
e-mail: donna.lochner@fda.hhs.gov

Laurence W. Grossman, Ph.D.
Director
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
e-mail: laurence.grossman@fda.hhs.gov

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
e-mail: baldwint@nhlbi.nih.gov

Semahat S. Demir
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
email: sdemir@nsf.gov

Updated July 17, 2008

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