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The CARILLON: Device Iteration, New Data and New Trials
Steven L. Goldberg, MD Director, Cardiac Cath Lab Clinical Associate Professor of Medicine University of Washington Medical Center Chief Clinical Officer Cardiac Dimensions, Inc.
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Disclosures Consultant Cardiac Dimensions – Chief Clinical Officer
Stock-options (Cardiac Dimensions, Inc.) I will be speaking about Investigational Devices
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CARILLON® Mitral Contour System™
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Device Iteration
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Twist added to improve anchor stability
Modification of proximal anchor to address clinically silent wireform fractures
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Device Integrity Observation
Strain Reliefs, 2 Fx Proximal Eyelet, 8 Fx “Cosmetic” – no clinical implications No complications and similar efficacy as non- fracture patients 7 7
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Minor device modifications
Old XE2 Current XE2
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New Data
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Baseline Demographics Intent to Treat Population (n=53)
TITAN™ Trial Age (yrs) 62.0 (24-79) Gender M = 77% (41) F = 23% (12) Ischemic Non-Ischemic 62% 38% NYHA Class II - 1 III - 50 IV - 2 EF 28% (9-39) MR (Baseline) 2+ = 16 3+ = 29 4+ = 8 LVEDD (mm) 70 (55–81) 11 11
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Baseline Demographics Intent to Treat Population (n=53)
TITAN™ Trial Age (yrs) 62.0 (24-79) Gender M = 77% (41) F = 23% (12) Ischemic Non-Ischemic 62% 38% NYHA Class II - 1 III - 50 IV - 2 EF 28% (9-39) MR (Baseline) 2+ = 16 3+ = 29 4+ = 8 LVEDD (mm) 70 (55–81) 12 12
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TITAN – MR Results Absolute differences from baseline
Non-Implanted Implanted * *** * *** cm2 cm ml % Area *p<0.05, **p<0.01, ***p<0.001 Paired between groups comparison of absolute differences from baseline 13
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Titan – LV Remodeling Results Absolute differences from baseline
Non-Implanted Implanted * ml ** cm * cm * * ml *p<0.05, **p<0.01, ***p<0.001 Between groups comparison of absolute differences from baseline 14
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TITAN Long Term Efficacy Results Implanted Patients
NYHA Class meters Baseline 1 Month 6 Months 12 Months 24 Months 36 Months Repeated measures ANOVA 15 15
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New Trials
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PRIME: Percutaneous Repair In functional Mitral REgurgitation
TITAN II sites Clermont-Ferrand TITAN II Assessment of device modified to prevent wireform fractures PRIME: Percutaneous Repair In functional Mitral REgurgitation Initial Commercialization Experience with 5 year follow-up Germany/Italy….. Neuss Poznan Köln Frankfurt
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1 year follow-up – no fracture (No fracture seen in TITAN II)
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Similar quantitative echo improvements in TITAN II as TITAN
Jet area/Left atrial area Regurgitant Volume N = 34 N = 9 Improved implant rate – 82%
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A great acute result (PRIME) University of Leipzig (1st day with Carillon)
Baseline Implant (Intraprocedural)
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A rather remarkable observation Neuss, Germany
Baseline Implant (Intraprocedural)
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Baseline VC – 0.52 Post VC – 0.35
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12 month follow-up Neuss, Germany
Baseline 12 month CONFIDENTIAL
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TITAN – MR Results Absolute differences from baseline
Non-Implanted Implanted * *** * *** cm2 cm ml % Area *p<0.05, **p<0.01, ***p<0.001 Paired between groups comparison of absolute differences from baseline 24
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Conclusions Placement of the CARILLON Mitral Contour System associated with improvement in MR over year after implant, with clinical benefits seen out to 3 years This new therapy for functional MR now available for commercial implantation in selected countries (and growing), with planned registry follow-up (PRIME)
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THANK YOU! CARILLON BELLS KIRKLAND, WASHINGTON
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