Heart Valve Pulse Duplicator

• Dual chamber pulse duplicator
• 3 independent activation systems for optimum ventricular, atrial, and systemic circulation
• Accurate ventricle and atrium anatomical models
• Versatile configuration for valve hydrodynamic performance in left and right heart
• 2 distinct valve positions - Aortic and Mitral
• Fulfill ISO 5840 and FDA guidelines requirements
• Multiple Electromagnetic flow meter and pressure transducers positions
• Compatible with valve leaflets kinematics assessment systems: high speed video
• Compatible with flow kinematics assessment systems: Particle Image Velocimetry and Echo Doppler

• Valve pressure gradient measurements
• Geometric Orifice Area (valve opened) determination
• Regurgitation Orifice Area (valve closed) assessment
• Effective Orifice Area (EOA) assessment
• Regurgitant volumes measurements

• Hydrodynamic performance of artificial heart valves prosthesis - Aortic, Mitral, Pulmonary
• Hydrodynamic performance of any valvular prosthesis
• Hydrodynamic performance of surgical, transapical, TAVI and any transcatheter valves
• Hydrodynamic performance of biological, polyester, mechanical valves

• ISO 5840 - Cardiovascular implants – Cardiac valve prostheses
• FDA Guidelines - Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications

• Flow characterization studies (PIV & Echo Doppler)
• Device pre-conditioning - Simulated use on IDTE 2000
• Accelerated Stent Fatigue Testing
• Post deflection, Burst pressure, Valve migration
• Accelerated Wear and Tear
• Corrosion resistance
• Steady Flow Testing
• Leaflet kinematics
• Ring integrity, Ring push off, Ring torque
• Stent creep (polymeric stent)
• Leaflet impingement & escape force (mechanical valve)

Dual chamber pulse duplicator for hydrodynamic performance testing of heart valves. 3 independent pump activation systems for ventricular, atrial, and systemic circulation. Anatomical ventricle and atrium models. The pressure difference and the regurgitant volume can be evaluated in-vitro under different flow conditions. Ventricular stroke volume, heart rate and diastolic and systolic aortic pressures can easily be modified to customer’s requirements. The repeatability of measurements is ensured by a servo-control, which also monitors pressure and flow waveforms.

• Custom anatomically accurate ventricle, atrium and aortic root models
• Accurate ventricle and atrium anatomical models
• Versatile configuration for valve hydrodynamic performance in left and right heart
• Custom rigid or soft aortic or mitral fixture adaptable to all valves
• Simulation of cardiac output from 2 to 7 L/min
• Tunable systolic ejection volume (30 up to 130 ml)
• Tunable heart rate (40 up to 130 cycles/min)
• Tunable systolic duration (for example: 35+/-5% of cycle at 70+/-10 c/min)
• Tunable systemic and pulmonary compliances and resistances allowing tunable aortic and pulmonary pressures waveforms
• Variable-compliance aortic chamber for stentless valve
• Compatible with high speed video systems, PIV equipment and echo doppler equipment
• GLP Qualified test bench and software
• Provided with full IQOQPQ plan and documents

Control module specifications

• High fidelity pressure difference sensor (accuracy +/- 1 mmHg FS)
• Accurate electromagnetic flow measurement (accuracy +/- 1 mL/s FS) allowing volume measurement of +/- 2mL
• Embedded temperature sensor (accuracy +/- 1° C)
• Compatible with blood analog (4 +/- 0.2 cP at test temperature) test fluid
• High speed simultaneous data acquisition of pressure, flow and temperature levels
• External trigger for echocardiographic or PIV synchronization
• Indirect real time closed-loop PID activation control system

Software specifications

• Actual pressure, flow and temperature measured, displayed and graphed
• Raw data and test parameters recorded to a CSV file