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 […]
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: […]
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 […]
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 […]
Catheter Testing – Functional Performance
Catheter Testing: Measured parameters Trackability Crossability Pushability Flexibility/Kink Torquability Rotational response Torque to failure Tip stiffness
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 […]
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 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 […]
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 […]
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 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: […]
Vascular Prosthesis Testing
Vascular Prosthesis Testing: Type Any device using vascular prostheses Vascular prosthesis Biological, synthetic textile/non-textile materials, non-textile material Stent Grafts: SX or BX frame, NiTi, CrCo, SS, Biological tissues, synthetic textile […]
Stent Radial Force Measurement (Displacement Control)
Stent Radial Force: Measured parameters Crush resistance – Load under constant displacement Stent Hoop force Stent Radial force Stent Diameter Temperature Stent Radial Force Measurement: Scope Balloon expandable and self-expanding […]
Stent Crush Resistance (Pressure Control)
Stent Crush Resistance Test: Measured parameters Applied pressure Dimensional variations Temperature Stent Crush Resistance Test: Scope Small peripheral stents Neurostents Non-cylindrical heart valve stents and other non-cylindrical stents Stent Crush […]
Coronary and peripheral stent
Coronary Peripheral Stent Coronary and peripheral stent: Type Any vascular stent Coronary stent Peripheral stent: Cerebra, abdominal, renal, iliac, femoral Stainless Steel, NiTi, CrCo, Mg Alloy, PLA Stent BX, SX […]
Heart Valve Testing
Heart valve testing: Type Heart valve prostheses Heart Valves: Mechanical, Biological, Synthetic Heart Valves: Surgical or TAVI Heart valve testing: Associated tests Hydrodynamic performance Accelerated Wear and Tear Flow Visualization […]
Endovascular Catheter
Endovascular Catheter: Type Endovascular delivery systems and catheters Angioplasty catheters PTA, PTCA catheters TAVI delivery systems Any interventional devices Endovascular Catheter: Associated tests Acute particulate evaluation Radiopacity Optical Inspection Any […]
Vascular Prosthesis
Vascular Prosthesis – POLYMAILLE 1 – Courtesy of PEROUSE MEDICAL Vascular Prosthesis: Type Any device using vascular prostheses Vascular prosthesis Biological, synthetic textile/non-textile materials, non-textile material Stent Grafts: SX or […]
Guidewire Testing – Functional Performance
Guidewire Testing: Measured parameters Tensile strength Torque strength Trackability Pushability Flexibility/Kink Torquability Tip stiffness Coating integrity Crossability Catheter compatibility Rotational response Torque to failure
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 […]