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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 will be 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

Rooms are being held for meeting attendees at the Bethesda Marriott at the corporate rate of $279. This rate will be offered based upon availability; after which time, the best available rate will be offered. Guests can call 1-800-228-9290 to make reservations and will be required to provide a credit card to guarantee lodging; otherwise one night’s deposit will be due.

Other area hotels include:

Hyatt Regency Bethesda
7400 Wisconsin Avenue
Bethesda, MD 20814
301-657-1234

Residence Inn Bethesda Hotel
7335 Wisconsin Avenue
Bethesda, MD 20814
301-718-0200

Clarion Hotel Bethesda Park
8400 Wisconsin Avenue
Bethesda, MD 20814
1-877-424-6423

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Agenda (preliminary)

Tuesday, March 18, 2008

8:00-8:15am Welcoming remarks 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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Registration

Registration for this workshop is being managed by B L Seamon Corporation. You may register on-line, or by calling B L Seamon. On-site registration will not be available. The registration fee is $250 and includes lunch and dinner on March 18, and lunch on March 19.

To register, please call B L Seamon at 301-577-0244 or visit the B L Seamon website at:

http://www.blsmeetings.net/H1369

Registration Cancellations

The deadline to request a registration refund is March 5, 2008. Refunds will no longer be processed after this date.

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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 March 5, 2008

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