Mitral Programme Update Azeem Latib MD EMO-GVM Centro Cuore - - PowerPoint PPT Presentation
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
EMO-GVM Centro Cuore Columbus and San Raffaele Scientific Institute, Milan, Italy
Direct Flow Medical Innovations in the Aortic and Mitral Programmes
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
Advantages
mitral anatomy
trans-aortic access
position)
implantation (even more critical in dynamic mitral
annulus)
radial force for anchoring
Wire management and retrieval
configuration)
Rings
CAUTION: Investigational device. Limited by federal law to investigational use.
Bench evaluation in Porcine Mitral Position
Atrial view
CAUTION: Investigational device. Limited by federal law to investigational use.
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
Failing ring Ring size (mm) Implanted DFM (mm) Successful? LVOT obstruction? Final MR grade St Jude Seguin 34 29 Yes No Edwards Physio 30 27* No No 4 Medtronic CG Future 26 25 Yes Initially, not following reposition Edwards Physio 28 25 Yes No 1 Medtronic CG Future 28 29 Yes No 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 Edwards Physio 30 27 Yes No Edwards IMR Rigid Ring 28 23 Yes No 2 Edwards Physio 32 29 Yes No
Failing Mitral Bioprosthesis Valve size (mm) True ID (mm) Implanted DFM (mm) Successful Implantation 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
First-in-man transapical mitral valve replacement using the Direct Flow Medical aortic valve prosthesis
Fritz Mellert1†, Jan-Malte Sinning2†, NikosWerner2, ArminWelz1, Eberhard Grube2, Georg Nickenig2*, and Christoph Hammerstingl2
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.
Unique potential design advantages:
Mitral ViV Mitral ViR Mitral Annular Calcification Mitral Valve Replacement
CAUTION: Investigational device. Limited by federal law to investigational use.
Confidential 15
Proven TAVI Technology
Technology Direct Flow Medical Mitral valve Proprietary Sealing Cuff Technology
into a conformable sealing cuff
prior to placement
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Confidential 24
– Precise placement – Conformable annular seal – Excellent PVL performance – Repositionable & retrievable
– Atrialized design – Minimal stasis | LVOT obstruction
– Allow normal native leaflet movement
– Facilitates future trans-septal approach – No stent fracture risk – Minimal perforation risk
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Porcine Adrenaline Challenge
Established TAVI system Advancing a promising mitral program
Universal design platform Incorporates proven aortic valve
Current: Pre-clinical investigation Target: FIM 2016
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Conformable sealing surface Minimal LV projection Repositionable and retrievable Maintains native leaflet mobility