Mitral Programme Update

Transcription

1 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

2 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

3 DFM Mitral Design Advantages Advantages Conformable device to accommodate complex mitral anatomy Flexible delivery system for transseptal or trans-aortic access Lowest PVL rates (even more critical in mitral position) Adjustable positioning Allows assessment of results before implantation (even more critical in dynamic mitral annulus) Proven design that does not rely solely on radial force for anchoring Atraumatic frame to preserve native chordae Retrievable Sealing and Anchoring Rings Atraumatic frame Challenges: Limited length in TA anatomy for Position Wire management and retrieval Transapical approach only (with current configuration) No tissue anchoring fixation Limited Diameter Conformable shape Flexible Delivery Maintain sufficient LVOT clearance CAUTION: Investigational device. Limited by federal law to investigational use.

4 Direct Flow Chronic Studies Bench evaluation in Porcine Mitral Position Atrial view CAUTION: Investigational device. Limited by federal law to investigational use.

5 DFM for Mitral Valve-in-Ring DFM in radiolucent ring No MR post-implantation Top of valve Mid-valve Bottom of valve Follow-up CT showing conformability of DFM to surgical ring

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7 DFM for Mitral Valve-in-Ring Failing ring Ring size (mm) Implanted DFM (mm) Successful? LVOT obstruction? Final MR grade St Jude Seguin Yes No 0 Edwards Physio 30 27* No No 4 Medtronic CG Future Yes Initially, not following reposition 0 Edwards Physio Yes No 1 Medtronic CG Future Yes No 0 St Jude Seguin Yes No 1 Medtronic CG Future 30 29* No Yes 4 Medtronic CG Future Yes No 1 Medtronic CG Future Yes No 0 Edwards Physio Yes No 0 Edwards IMR Rigid Ring Yes No 2 Edwards Physio Yes No 0

8 DFM for Mitral Valve-in-Valve

9 Valve-in-Valve Case Examples Failing Mitral Bioprosthesis Valve size (mm) True ID (mm) Implanted DFM (mm) Successful Implantation Pericarbon Yes Carpentier-Edwards Yes Epic Yes Perimount Yes Epic Yes Perimount Yes

10 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 MAC CAUTION: Investigational device. Limited by federal law to investigational use.

11 mitral DFM DFM for for native native mitral mitral and and aortic aortic stenosis Annulus 34mm U. Schäfer MD

12 DFM for native mitral and aortic stenosis aortic Annulus 27.1mm U. Schäfer MD

13 Double DFM AS & MAC

14 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 ViV Mitral ViR Mitral Annular Calcification Mitral Valve Replacement CAUTION: Investigational device. Limited by federal law to investigational use.

15 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

16 Direct Flow Medical Universal Valve Design TMVR Solution Proven TAVI Technology Proprietary Sealing Cuff Technology Direct Flow Medical Mitral valve

17 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

18 Acute Porcine Implant 18

19 Unsheathing

20 Inflating

21 Pull-Back and Anchor

22 Detach

23 Final Echo Result: No MR, No leak, Normal valve leaflet motion

24 Adrenaline Challenge 130 Bpm 150 Bpm Confidential 24

25 Direct Flow Medical Anticipated Mitral Valve Design Benefits Clinically proven conformable design 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 Porcine Adrenaline Challenge 25

26 TMVR Program Conclusions Direct Flow Medical Established TAVI system Advancing a promising mitral program Unique design attributes Universal design platform Incorporates proven aortic valve Unique design benefits Conformable sealing surface Minimal LV projection Repositionable and retrievable Maintains native leaflet mobility TMVR program status Current: Pre-clinical investigation Target: FIM