Opsens — Technical Presentation (November 2021)
12 slides from Opsens's technical presentation, Nov 5, 2021
Slide 1: Initial Experience with the SavvyWire
Initial Experience with the SavvyWire Josep Rodés-Cabau, MD A Pressure Wire for Valve Implantation and Continuous Hemodynamic Monitoring During TAVR Procedures
Slide 2: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest I, [insert name] DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. Faculty Facultydisclosure disc
Slide 3: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Company Name(s) Consulting Fees/Honoraria Com
Slide 4: OpSens SavvyWire Description
OpSens SavvyWire™ Description Structural Pre-Shaped Guidewire with Pressure Measurement and Rapid Pacing capabilities • 0.035" stiff guidewire Shaft Stiffness • Exchange length for valve catheters, 280cm Safari < SavvyWire < Confida • Pre-Shaped tip, 2 sizes available (XS & Small) • Orange PTFE coat
Slide 5: OpSens OptoMonitor TAVI interface
OpSens OptoMonitor™ TAVI interface • Live hemodynamics feedback without catheter exchange Example from FIM: Gradient at baseline Gadients (mean, max, P2P) Regurgitation indices (ARi, TIARi) Valve Ao Pigtail SavvyWire Pressure sensor Ext. Transducer Note: Data from FIM was imported retrospectivel
Slide 6: SAVVY Study - First in Man Clinical Trial
SAVVY Study - First in Man Clinical Trial • Prospective observational feasibility study • 20 patients Inclusion: Severe asymptomatic AS Exclusions: Extremely calcified valve, Extremely horizontal aorta, Severe septal hypertrophy, Extreme access tortuosity, Prohibitive surgical risk, Patients <18
Slide 7: Guidewire Support – FIM example
Guidewire Support – FIM example Ventricular positioning Valve delivering
Slide 8: Guidewire Support – FIM example
Guidewire Support – FIM example Valve crossing Valve deployment
Slide 9: Rapid pacing
Rapid pacing • Unipolar left ventricular pacing Example from FIM: Pacing test before inserting valve catheter • Built-in shaft insulation LV pacing at anytime, without catheter • Eliminates RV access for eligible patients • Surgical pacing cables from external pacemaker: Note: Data from FIM was im
Slide 10: Hemodynamics report
Hemodynamics report Example from FIM: Hemodynamics comparison pre and post procedure Immediate pre and post comparison report on OptoMonitor • Pressures (Sys, Dias, LVEDP) • Gradients (Mean, Max, P2P) • Regurgitation (ARi, TIARI, Ratio) • Heart Rate • Export to DICOM • Export to USB Note: Data from
Slide 11: Conclusion – SavvyWire functions
Conclusion – SavvyWire functions 1. Valve Implantation Stiff pre-shaped guidewire 2. Hemodynamics Quantify valve performance 3. Heart Stimulation Rapid pacing capability
Slide 12: SAVVY Simultaneous First in man Teams
SAVVY Simultaneous First in man Teams Quebec Heart and Lung Institute Montreal Heart Institute Dr. Josep Rodés-Cabau Dr. Reda Ibrahim