A New Study Paradigm for Novel Medical Devices in the US: Early Feasibility Studies & Neurovascular Device Development
Moderated by Ansaar Rai, MD, FSNIS & Adnan Siddiqui, MD, PhD
Setting the Stage
3:00 pm – 3:10 pm EFS: A Useful Tool in the Development of Novel Medical Devices, Andy Farb, MD, US FDA
3:10 pm – 3:20 pm Process Improvement in the EFS Clinical Trial Ecosystem: A Collaborative Effort, Liz Mino, MDIC
3:20 pm – 3:30 pm Leveraging the University of California System to Improve Stroke Care, Steven Hetts, MD
Real World Case Studies
3:30 pm – 3:40 pm A Sponsor’s View: Utilizing the EFS Pathway for a Novel Neurointerventional Device, Bruce Van Deman, Medtronic
3:40 pm – 3:50 pm Perspectives on Neurovascular Clinical Studies
3:50 pm – 4:00 pm A Clinical Site’s View: Challenges and Success of Conducting EFS Studies
Open Discussion
4:00 pm – 5:00 pm How Should all the Stakeholders Come Together to Ensure a Robust Ecosystem for the Conduct of Neurovascular Clinical Studies in the US?