Stent Fatigue Testing: Measured parameters Strain: Direct periodic strain measurement performed with ultrasonic (US) dynamic diameter measuring system Struts and Diameter integrity – Periodic visual inspection and final SEM inspection Cyclic system pressure […]
Catheter Testing – Functional Performance
Catheter Testing: Measured parameters Trackability Crossability Pushability Flexibility/Kink Torquability Rotational response Torque to failure Tip stiffness
Heart Valve Testing – Steady Flow
Heart Valve Testing – Steady Flow: Measured parameters Strain Measure of the transvalvular pressure gradient Evaluate the Effective Orifice Area (EOA) of the valve Measure of static leakage flow (transvalvular […]
Heart Valve Testing – Pulsatile Flow
Heart Valve Testing – Pulsatile Flow: Measured parameters Valve pressure gradient Geometric Orifice Area (valve opened) Regurgitation Orifice Area (valve closed) Effective Orifice Area (EOA) Measure regurgitant volumes for different […]
Heart Valve Fatigue Testing – Accelerated Wear and Tear
Heart Valve Fatigue Testing: Measured parameters Leaflet durability – wear test Leaflet kinematics – opening and closing behavior Valve hydrodynamic performance inspections Visual and SEM inspections Heart Valve Fatigue Testing: […]
Acute Particulate Matter Evaluation
Acute Particulate Matter Evaluation: Measured parameters Total cumulative number of particulate matter released from the device during Unconstrained device deployment Simulated use conditions Background noise assessment 75% and […]
Stent Finite Element Analysis – Fatigue Assessment
Stent Finite Element Analysis: Measured parameters Maximum Stress & Strain: From initial loading to final device deployment Recoil and Foreshortening after loading Recoil and Foreshortening after deployment Operating Stress Levels Stent […]
Balloon Catheter Testing
Balloon Catheter Testing: Measured parameters Balloon fatigue assessment Inflation and deflation time Rate burst pressure Balloon compliance Pressurized Water Leak Test Pressurized Air Leak Test Catheter Bond Strength Catheter Torsion […]
Finite Element Analysis Stent
Finite Element Analysis Stent FEA: Measured parameters Global behavior and mechanical properties (stress, strain, etc) of device during various loadings (crimping, expansion, etc) Stent Recoil behavior Stent Foreshortening behavior Stent […]
Pulsatile Flow Visualization – Piv, Echo Doppler
Pulsatile Flow Visualization: Measured parameters Qualitative pulsatile flow visualization Quantitative pulsatile flow visualization – PIV Flow Doppler measurements – echocardiography Pulsatile Flow Visualization : Scope Transcatheter valves Biological valves Mechanical […]
Fatigue Testing Medical Device – Customized Studies
Fatigue Testing Medical Device – Tester Customized Design Fatigue Testing Medical Device: Measured parameters Strains (Displacement) Number of cycles Test frequency Test temperature Fatigue Testing Medical Device: Scope Medical device […]
Service Levels – Medical Device Testing
Medical device testing service levels : ProtomedLabs offers a large selection of medical device testing tailored to meet medical device testing requirements. Our four service levels are designed to provide […]
Flexibility Kink Resistance
Flexibility Kink Resistance: Measured parameters Ability of the device to bend in order to accommodate the predetermined clinically relevant radius or angle it will be required to negotiate during access […]
Stent Radiopacity
Stent Radiopacity: Measured parameters X-ray images X-ray imaging system settings (voltages, times and currents, DSI, image cadence, source-to-detector distance, sample-to-detector distance, isocenter-to-focus distance) Stent Radiopacity: Scope Radiopacity coronary and peripheral […]
Stent Corrosion Testing – Cyclic Potentiodynamic Polarization
Stent Corrosion Testing: Measured parameters Different potentials : Er (rest potential), Eb (breakdown potential), Ep (protection potential), Ev (vertex potential) icor (corrosion current in A) rest potential evolution in function […]
Stent Recoil, Foreshortening, Compression
Stent Recoil, Foreshortening, Compression: Measured parameters Stent recoil: Percentage by which the diameter of a stent decreases from its expanded diameter (when the balloon is inflated at the nominal pressure) to […]
Stent Galvanic Corrosion Testing
Stent Galvanic Corrosion Testing: Measured parameters Rest potential before and after the experiments Galvanic current (in A) and galvanic corrosion evolution in function of time Corrosion rate using equation (mm/year) […]
Stent Securement – Dislodgement Force
Stent Securement – Dislodgement Force: Measured parameters Force required to completely dislodge the stent from the delivery system balloon Stent securement force Stent Securement – Dislodgement Force: Scope Stent Balloon […]
Stent Corrosion Testing – Degradation products
Stent Corrosion Testing: Measured parameters Degradation rate during corrosion testing (µg/cm²/h) Electrochemical behavior curves Stent Corrosion Testing: Scope Identifying and quantifying degradation products from finished metallic medical devices during corrosion […]
Stent Uniformity of Expansion
Stent Uniformity of Expansion: Measured parameters Stent expansion uniformity: Difference between the largest and smallest diameter measurement on a single stent deployed to its labelled diameter Stent Uniformity of Expansion: […]