Public Workshop

The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Methods for Thrombogenicity Testing”.

The purpose of this workshop is to discuss the advantages and limitations of both in vivo and in vitro thrombogenicity test methods.  Methods related to the testing of blood contacting devices for a broad range of cardiovascular applications will be discussed.  Ideas generated during this workshop will facilitate development of new guidance and standards for thrombogenicity testing optimizing current in vivo methods and/or utilizing in vitro methods.    

This meeting will be held April 14, 2014, beginning at 9:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

• Link for FDA Campus Information

This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on April 4, 2014.

Time
Subject
Name of Speaker/
8:00–9:00 am
Registration
 
9:00–9:15 am
Welcome and Overview of the Current FDA Approach to Thrombogenicity Evaluation
Jen Goode, FDA
9:15–9:30 am
Rates of Thrombus Events in Blood Contacting Medical Devices
Anchal Kaushiva, FDA
9:30–9:45 am
Evaluation of Blood Hypercoagulability
Dennis Galanakis, Stony Brook University Medical Center
9:45–10:15 am
Thrombogenicity Testing in the 21st Century:  Time for Alternative Strategies for Medical Devices? 
Mike Wolf, Medtronic, Inc.
10:15–10:30 am
Discussion
 
10:30–10:45 am
Break
 
10:45–10:50 am
Summary of Results from Pre-Workshop Assignment: In Vivo Practices
James Kleinedler, FDA
10:50–11:10 am
FDA Perspective: Insights on Thrombogenicity from the Large Animal Safety Studies
Michael John, FDA
11:10–11:30 am
Alternative Interventional/Surgical Methods for the In-vivo Thrombogenicity Test
Kent Grove, American Preclinical Services, LLC
11:30–11:45 am
Summary of Results from Pre-Workshop Assignment: In Vitro Practices
James Kleinedler, FDA
11:45–11:55 am
The Use of PTT and PT Assays for Thrombogenicity Evaluation: An FDA Perspective
Qijin Lu, FDA
11:55 am–12:15 pm
Hemocompatibility Testing in the 21st Century: Options and Pitfalls
Hans Wendel, University Hospital Tuebingen, Germany
12:15–1:00 pm
Lunch
 
1:00–1:20 pm
Possibilities of Thrombogenicity Testing by means of In Vitro Systems
Wim van Oeveren, HaemoScan
1:20–2:20 pm
Panel Discussion
 
2:20–2:25 pm
Summary of Results from Pre-Workshop assignment: Device Specific Considerations
James Kleinedler, FDA
2:25–2:45 pm
In-vitro Blood Flow Models for the Assessment of Thrombosis: Device Specific Challenges
Sivaprasad Sukavaneshvar, Thrombodyne Inc.
2:45–3:05 pm
 Challenges in Predicting Device Thrombogenicity in Preclinical Animal Validation Studies: A Perspective from a Translational Research Laboratory
Greg Kaluza, Skirball Center for Cardiovascular Research
3:05–3:20 pm
Break
 
3:20–3:40 pm
Thrombogenicity of Mechanical Circulatory Support Devices: Experience and Challenges from Design to Clinical Use
Zhongjun (Jon) Wu, University of Maryland
3:40–4:45 pm
Panel Discussion
 
4:45–5:00 pm
Recap and Potential Future Efforts
Anchal Kaushiva, FDA

If you wish to attend this Workshop, you must register by close of business on April 4, 2014. 

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis.  Early registration is recommended because seating is limited.