Stent Summit 2012

August 25, 2011 | August 26, 2011 | August 27, 2011

Thursday, August 25, 2011

7:00 am	Registration Opens Continental Breakfast
8:00 am	Anatomy and Pathophysiology of the IVC and Pulmonary Embolization David Gillespie, MD, RVT, FACS
8:15 am	Discussion
8:45 am	Current Status of Approved and Upcoming Devices, Patient Selection and Device Sizing: Introduction to Filter Designs, IVC characteristics, and General Technology Matthew Johnson, MD, FSIR
9:00 am	Discussion
9:15 am	Treatment Failure: Recurrent PE, IVC Thrombosis Mark Sands, MD
9:30 am	Discussion
9:45 am	Break
10:00 am	Deployment Issues: IJ versus Femoral Introduction, Sizing,Tilt Michael Drake, MD
10:10 am	Company Presenter
10:20 am	Discussion
11:00 am	Retrieval Issues: Mandatory? Elective? Complicated? Lindsay Machan, MD
11:10 am	Discussion
12:00 pm	Lunch
12:30 pm	Lunch Panel (Open Discussion) Inventor Perspective: I have a new device that I think is ready for clinical testing; where should I start (US, EU or elsewhere)? Moderator: Bram Zuckerman, MD Panel: Roy Greenberg, MD; Michael Dake, MD; Daniel Clair, MD; Ken Cavanaugh, Jr. PhD; Pablo Morales, MD; Lindsay Machan, MD
1:30 pm	Filter Fixation and Migration: Forces and Design Matt Johnson, MD, FSIR
1:40 pm	Company Presenter
2:30 pm	Device and Tissue Integrity: Strut Fracture and Vessel Wall Perforation David Gillespie, MD, RVT, FACS
2:40 pm	Company Presenter
3:50 pm	Summary of Discussion and Action Points
5:00 pm	Meeting Adjourn
6:15 pm	Shoreby Club Dinner Shuttle departs from Hotel Lobby

Friday, August 26, 2011

7:00 am	Registration Opens Continental Breakfast
Objectives Review how endovascular grafts that are used in the arch have been evaluated. Review and clarify the unmet clinical needs for addressing arch pathologies with endovascular grafts: Identify any clinical challenges with using endovascular grafts: within the labeled indications (i.e., aneurysms within the anatomical limitations); and outside of the labeled indications (e.g., dissections, transections, higher in the arch, outside of the other anatomical limitations). Identify specific anatomy (e.g., small radius of curvature) and/or disease states that are not fully addressed with current devices. Translate clinical challenges to engineering considerations: Determine what additional anatomic and physiological data are needed to improve the design and preclinical testing of devices used: within the labeled indications; and outside the labeled indications. Identify, to the extent possible, new or modified preclinical tests that could better evaluate devices for treating various pathologies in Zones 3 and 4 and for treating various pathologies further up the aortic arch.
7:55 am	Introduction Roy Greenberg, MD Moderators: Roy Greenberg, MD and Dorothy Abel
8:00 am	Current Status of Approved Devices and Current Clinical Trials Michel Makaroun, MD
8:10 am	Current Status of Approved Devices in Europe (Including France) Stephan Haulon, MD
8:20 am	Off Label Use, Future Directions Mark Farber, MD
8:30 am	On and Off Label Use from a Preclinical Testing Perspective Robert Whirley
8:40 am	Discussion Introduction to challenges that have been encountered in the arch with current technology Identification of unique challenges with treatment of various lesion types (e.g., aneurysms, dissections, transections) Summary of how devices have been evaluated during preclinical testing
9:00 am	Proximal Endoleak, Collapse, Compression, and Mal-deployment: Seal and Conformability Mark Fillinger, MD
9:10 am	Company Presenter
9:20 am	Discussion Clinical perspective on the challenges with treating arch etiologies/anatomies with respect to sealing and conformability Manufacturer perspective on design inputs and outputs regarding seal and conformability Discussion: design inputs and testing implications
10:15 am	Break
10:30 am	Moderators: Ben Wolf and Peter Taylor Deployment Issues and Stroke: Deployment Accuracy and Safety Anthony Lee, PhD
10:40 am	Company Presenter
10:50 am	Discussion Clinical perspective on the challenges with treating arch etiologies/anatomies with respect to having deployment accuracy and safety Manufacturer perspective on design inputs and outputs regarding deployment accuracy and safety Discussion: design inputs and testing implications
11:45 am	Lunch
12:15 pm	Lunch Panel (Open Discussion) Manufacturer Perspective: We want to seek approval for commercialization - what information is needed from a clinical trial for approval? For reimbursement? For medical care? Moderator: Roy Greenberg, MD Panel: Bram Zuckerman, MD; Dorothy Abel; Peter Taylor, Ken Cavanaugh, Jr., PhD; Pablo Morales, MD; Stephan Haulon, MD
1:15 pm	Moderators: Stephan Haulon, MD and Matt Waninger Migration and Loss of Device Integrity: Fixation Peter Taylor
1:25 pm	Company Presenter
1:35 pm	Discussion Clinical perspective on the challenges with treating arch etiologies/anatomies with respect to having adequate fixation Manufacturing perspective on design inputs and outputs regarding fixation Discussion: design inputs and testing implications
2:30 pm	Break
2:40 pm	Retrograde Dissection: Fixation, Conformability, and Deployment Accuracy and Safety Michael Dake, MD
2:50 pm	Eric Roselli, MD
3:00 pm	Discussion Clinical perspectives on challenges with the creation and management of retrograde aortic dissections - with regard to wall apposition, sealing, motion, and fixation mechanisms. Discussion: design inputs and testing regulations to mitigate risk Manufacturer perspective on design inputs and outputs regarding fixation, conformability and deployment accuracy and safety as they relate to retrograde dissection
4:00 pm	Moderators: Dorothy Abel and Chris Cheng, PhD Panel of Manufacturers, Group Discussion and Wrap-up
6:15 pm	Cleveland Indians vs. Kansas City Royals - Progressive Field Shuttle departs from Hotel Lobby

Saturday, August 27, 2011

Wrap Up