Medical Devices

Public Workshop – Acute Ischemic Stroke Medical Devices Trials Workshop, October 6, 2015

The Food and Drug Administration (FDA) is announcing a public Workshop “Acute Ischemic Stroke Medical Devices Trials.”

The purpose of this workshop was to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for acute ischemic stroke emerging technologies and help to speed development and approval of future submissions.


Date, Time and Location:

This meeting was held October 6, 2015, beginning at 1:00 p.m. – 5:30 p.m. at the following location:

Bethesda Pooks Hill Marriott
5151 Pooks Hill Road
Grand Ballroom
Bethesda, MD, 20814

The workshop will be videotaped and posted to the web page after the workshop.

Transcript

Agenda

Time Subject Speaker
1:00–1:10 Introduction to Workshop Mary Lee Jensen (University of Virginia)
1:10–1:20 History of Stroke Devices Carlos Peña (FDA, CDRH)
1:20–1:35 Statistical Considerations Martin Ho (FDA, CDRH)
1:35–1:50 Lessons Learned from Clinical Trials in Acute Ischemic Stroke Michael Hill (University of Calgary)
1:50–2:05 Future of Stroke Trials Pooja Khatri (University of Cincinnati)
2:05–2:15 Breakout Session Instructions Carlos Peña (FDA, CDRH)
2:25–4:35 Concurrent Breakout Sessions: Session Moderators
2:25–3:25 Clinical Study Design Michael Hill (University of Calgary)
Donald F. Frei (Radiology Imaging Associates)
Patient Populations Michael Froehler (Vanderbilt University)
Pooja Khatri (University of Cincinnati)
Clinical Outcomes Sameer A. Ansari (Northwestern University)
James Grotta (University of Texas)
Safety Endpoints Patrick Lyden, (Cedars–Sinai)
Mary Lee Jensen (University of Virginia)
3:35–4:35 Clinical Study Design Michael Froehler (Vanderbilt University)
Pooja Khatri (University of Cincinnati)
Patient Populations Michael Hill (University of Calgary)
Donald F. Frei (Radiology Imaging Associates)
Clinical Outcomes Patrick Lyden, (Cedars–Sinai)
Mary Lee Jensen (University of Virginia)
Safety Endpoints Sameer A. Ansari (Northwestern University)
James Grotta (University of Texas)
4:35–4:55 Break  
4:55–5:25 Breakout Session Summaries  
5:25–5:30 Closing Remarks  

Contact Us

For questions regarding workshop content please contact:

Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, Bldg 66, rm 3625, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6815, Hilda.Scharen@fda.hhs.gov

Jamie Waterhouse, Project Manager, Neurointerventional and Neurosurgical Devices Branch, Division of Neurological and Physical Medicine Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3063, Jamie.Waterhouse@fda.hhs.gov

Page Last Updated: 11/16/2015
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