1. Devices for Stroke Prevention
CRT 2013
Washington DC, February 24, 2013
Devices for Stroke Prevention
Eberhard Grube MD, FACC, FSCAI
Universitätklinik Bonn,Medizinische Klinik II, Bonn
Stanford University, Palo Alto, California, USA

2. Eberhard Grube, MD
Consulting: Medtronic CoreValve, Boston Scientific Corporation, Cordis Corporation, Johnson and Johnson and Abbott Vascular
Honoraria: Boston Scientific Corporation and Biosensors International
Stocks, Stock Options, other ownership interest: Medtronic CoreValve and Biosensors International
Off-Label: Off-label use of stents and valve prosthesis 1

3. Embolic Protection Claret – Dual Filter Montage (Capture) CE Marked
6F Transradial or brachial delivery
Keystone – Deflector
Clinical Phase
9F Transfemoral delivery
Edwards/Embrella - Deflector T V T 2 1 2

4. Current Devices in Development
Emboline
Lumen Biomedical
Nitinol Frame – Nitinol Mesh Filter Material
7F Radial Filter/Occluder
Dual Balloon
Femoral Delivery, NiTi sleeve
CRT 2013 4

5. Claret Montage
6F Claret Montage – Delivered over a 0.014” Coronary Guidewire
Drilled Polyurethane – Nitnol Frame - One Deflects - One Filters Debris
CRT 2013 5

6. New Handle Design – Montage 2 CE Mark FEB-2013
1 - Proximal Filter
2 - Deflect Tip
3 - Distal Filter 6

7. Claret Montage
Distal Filter
Proximal Filter T V T 2 1 2

8. Claret Captures Clinical experience: Over 500 cases worldwide…
Drilled Polyurethane – Nitnol Frame - One Deflects - One Filters Debris
Clinical experience: Over 500 cases worldwide…
CRT 2013 9

9. Claret – Filter Embolic DebrisV T 2 1 2

10. Claret Montage Device Montage - Dual filter capture
Only protection system CE Marked
6F radial insertion over a 0.014” wire
Minimalistic approach (“nothing in the aorta”)
140 micron pore size
10-15 ml single contrast needed to place T V T 2 1 2

11. Keystone – Deflector T V T 2 1 2

12. Keystone – Deflector 9 French compatible retrievable device
‘stabilizer’
9FR Cook sheath
‘feelers’
6 Fr Pigtail
9 French compatible retrievable device
Protects entire cerebro-vascular system
Eliminates need for third access site during TAVI
Rapidly deploys and self-positions
Does not interfere with TAVI procedure T V T 2 1 2

13. Keystone - Deflector Device Body protecting all three take-offs
Vertical Stabilizer
positioned in innominate artery
Tether
for deployment & retrieval
Leading Edge
apposition to aortic wall T V T 2 1 2

14. Keystone – Deflector Results to date
Bench tests
98.5% reduction of cerebral emboli
Animal studies (sheep & pigs)
No arch or artery damage (in-dwelling time 2 to 48 hours)
No migration—stable in designated location
No blood clot formation (Surmodics Applause™ coating)
FIM pilot study, P Stella (PI) et al, EuroIntervention 8;1:51-57, 2012
Total n=35, n=15 with EDD and 10 with DWI, n=20 without EDD
Safe—no adverse events
Fast, simple deployment— average procedure time 7±2 min
Easy retrieval
Significant, 44% reduction in DWI findings; 3.2 vs 7.2 new lesions per patient with and without EDD resp.

15. Edwards Embrella – Deflector
Porous membrane designed to deflect embolic debris
Nitinol® Frame & Shaft
Hydrophillic Coating with antithrombogenitc properties
3 Radiopaque Markers
Suture; Monofilament Nylon T V T 2 1 2

16. Edwards Embrella – Deflector FIM
Site Number
Center
Principal Investigator
Number of Subjects Enrolled 01
St. Paul’s Hospital
Vancouver, BC
John Webb, M.D. 5 02
HELIOS Hospital Center
Siegburg, DE
Ralf Müller, M.D.
Ulrich Gerckens, M.D. 10 03
University Hospital
Hamburg, DE
Joachim Schofer, M.D. 01

17. Edwards Embrella - Deflector FIM
* Embrella subjects 1 BAV, 14 TF TAVI
**Ghanem et al, J Am Coll Cardiol 2010;55:1427–32 (TF TAVI)
***Astarci et al, Abstract presentation EACTS 2010 (TF TAVI) 27

18. Case selection: Heart Team (high-risk)
PROTAVI - C
Severe AS + Symptoms
Case selection: Heart Team (high-risk)
Randomization 1:1
Standard TAVR
Standard TAVR + Deflection
Primary Endpoint: Volume of
DW-MRI brain 1 wk
Re-Randomization 1:1
ASA alone
for 3 months
ASA + clopidogrel
for 3 months
2nd Primary Endpoint:
composite stroke/TIA +
1 year
Co-PIs: Profs Vahanian
and Beversdorf

19. Thank you….
CRT 2013