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 |
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| 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 |
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| 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 Panelists: 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 |
| 3:20-4:05 |
Session II-Nonclinical Model Development - continued
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| 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 |
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| 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 |
| 9:20-9:45 |
B) Emerging Modeling Techniques |
| 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 |
| 2:00-3:00 |
Panel Discussion-Research and Collaboration Policy Issues Craig Bonsignore, NDC |
| 3:00-3:20 | Networking Break |
| 3:20-4:45 | Brainstorming Session / Closing Remarks Moderated by the Workshop Organizing Committee |
Registration
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 robert.katayama@stanford.edu or phone at 650-862-3553.
Contacts
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
e-mail: donna.lochner@fda.hhs.gov
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
e-mail: taylorca@stanford.edu
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, 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
email: sdemir@nsf.gov
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
Email: ere@mit.edu
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
