Direct Flow Medical Innovations in the Aortic and Mitral Programmes Mitral Programme Update Azeem Latib MD EMO-GVM Centro Cuore Columbus and San Raffaele Scientific Institute, Milan, Italy
Potential conflicts of interest Speaker's name: Azeem Latib I have the following potential conflicts of interest to report: Consultant: DIRECT FLOW MEDICAL, MEDTRONIC, MILLIPEDE, MITRALIGN, AMARANTH MEDICAL Honorarium: ACIST MEDICAL, ABBOTT VASCULAR, SPECTRANETICS
DFM Mitral Design Advantages Advantages Conformable device to accommodate complex mitral anatomy Flexible delivery system for transseptal or trans-aortic access • Conformable shape • Sealing and Anchoring Lowest PVL rates (even more critical in mitral Rings position) • Flexible Delivery • Atraumatic frame Adjustable positioning • Challenges: • Limited length in TA anatomy for Position Allows assessment of results before Wire management and retrieval implantation (even more critical in dynamic mitral annulus) • Transapical approach only (with current Proven design that does not rely solely on configuration) radial force for anchoring • No “tissue anchoring” fixation Atraumatic frame to preserve native chordae • Limited Diameter Retrievable • Maintain sufficient LVOT clearance CAUTION: Investigational device. Limited by federal law to investigational use.
Direct Flow Chronic Studies Bench evaluation in Porcine Mitral Position Atrial view CAUTION: Investigational device. Limited by federal law to investigational use.
DFM for Mitral Valve-in-Ring No MR post-implantation DFM in radiolucent ring Top of valve Mid-valve Bottom of valve Follow-up CT showing conformability of DFM to surgical ring
DFM for Mitral Valve-in-Ring Ring size Implanted Failing ring Successful? LVOT obstruction? Final MR grade (mm) DFM (mm) St Jude Seguin 34 29 Yes No 0 Edwards Physio 30 27* No No 4 Initially, not following Medtronic CG Future 26 25 Yes 0 reposition Edwards Physio 28 25 Yes No 1 Medtronic CG Future 28 29 Yes No 0 St Jude Seguin 28 27 Yes No 1 Medtronic CG Future 30 29* No Yes 4 Medtronic CG Future 30 29 Yes No 1 Medtronic CG Future 30 29 Yes No 0 Edwards Physio 30 27 Yes No 0 Edwards IMR Rigid Ring 28 23 Yes No 2 Edwards Physio 32 29 Yes No 0
DFM for Mitral Valve-in-Valve
Valve-in-Valve Case Examples Failing Mitral Valve size Implanted True ID (mm) Successful Implantation Bioprosthesis (mm) DFM (mm) Pericarbon 29 25 27 Yes Carpentier-Edwards 31 27 27 Yes Epic 29 24.5 25 Yes Perimount 29 27 25 Yes Epic 29 24.5 25 Yes Perimount 29 27 25 Yes
MAC First-in-man transapical mitral valve replacement using the Direct Flow Medical aortic valve prosthesis Fritz Mellert 1† , Jan-Malte Sinning 2† , NikosWerner 2 , ArminWelz 1 , Eberhard Grube 2 , Georg Nickenig 2 *, and Christoph Hammerstingl 2 1Department of Cardiac Surgery, Heart Center Bonn, University Hospital Bonn, Bonn, Germany; and 2Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany The case demonstrates that MV disease with severely calcified MV annulus may be treated by TMVR with a repositionable transcatheter aortic valve prosthesis in selected high risk patients. Valve size implanted: 29 mm MR final: 0 Adverse events: no CAUTION: Investigational device. Limited by federal law to investigational use.
DFM for native mitral and aortic stenosis DFM for native mitral and aortic stenosis mitral Annulus 34mm U. Schäfer MD
DFM for native mitral and aortic stenosis aortic Annulus 27.1mm U. Schäfer MD
Double DFM – AS & MAC
DFM and the Mitral Space Universal Platform: Addressing Mitral Valve Disease Unique potential design advantages: • Double-ring valve for optimal sealing • Valve design accomodates D-Shape • Upsizing to mitral diameters feasible • Metal-free design/profile facilitates trans-septal delivery • Repositionable/retrievable (LVOT Obstruction, Sizing) Mitral Annular Mitral Valve Mitral ViV Mitral ViR Calcification Replacement CAUTION: Investigational device. Limited by federal law to investigational use.
Current Challenges of TMVR • Paravalvular leak • Anchoring • LVOT obstruction • Erosion • Thrombus – Atrial and ventricular • Stent fracture • Unproven valve/leaflet durability • Lack of repositionability and retrievability Confidential 15
Direct Flow Medical Universal Valve Design TMVR Solution Proven TAVI Proprietary Sealing oprietary Sealing Direct Flow Medical Technology Cuff Technology Technology Mitral valve
DFM Mitral Bioprosthesis Universal Valve Design Platform • Transapical approach • Proven aortic valve integrated into a conformable sealing cuff • Conformable sealing cuff design requires fewer valve sizes • Minimal LV projection • Assess hemodynamics prior to placement • Repositionable | fully retrievable
Acute Porcine Implant 18
Unsheathing
Inflating
Pull-Back and Anchor
Detach
Final Echo Result: No MR, No leak, Normal valve leaflet motion
Adrenaline Challenge 130 Bpm 150 Bpm Confidential 24
Direct Flow Medical Anticipated Mitral Valve Design Benefits • Clinically proven conformable design Porcine Adrenaline Challenge – Precise placement – Conformable annular seal – Excellent PVL performance – Repositionable & retrievable • Low ventricular projection – Atrialized design – Minimal stasis | LVOT obstruction • Trigone anchors – Allow normal native leaflet movement • Non metallic construction – Facilitates future trans-septal approach – No stent fracture risk – Minimal perforation risk 25
TMVR Program Conclusions Direct Flow Medical Established TAVI system Advancing a promising mitral program Unique design benefits Unique design attributes Conformable sealing surface Universal design platform Minimal LV projection Incorporates proven aortic valve Repositionable and retrievable Maintains native leaflet mobility TMVR program status Current: Pre-clinical investigation Target: FIM 2016 26
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