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
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
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
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
Claret Montage 6F Claret Montage – Delivered over a 0.014” Coronary Guidewire Drilled Polyurethane – Nitnol Frame - One Deflects - One Filters Debris CRT 2013 5
New Handle Design – Montage 2 CE Mark FEB-2013 1 - Proximal Filter 2 - Deflect Tip 3 - Distal Filter 6
Claret Montage Distal Filter Proximal Filter T V T 2 1 2
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
Claret – Filter Embolic Debris V T 2 1 2
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
Keystone – Deflector T V T 2 1 2
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
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
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.
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
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
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
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 lesions @ 1 wk Re-Randomization 1:1 ASA alone for 3 months ASA + clopidogrel for 3 months 2nd Primary Endpoint: composite stroke/TIA + bleeding @ 1 year Co-PIs: Profs Vahanian and Beversdorf
Thank you…. CRT 2013