Vascular Implants Testing

STEMart can establish the testing plan, develop and validate the testing protocols, and execute all the tests according to ASTM and ISO standards.

Applicable Standards

• ASTM
• ISO
• FDA Guidance

Test Capabilities

• Dimensional Attributes
• Measure the maximum diameter along section of the stent system for evaluation of the dimensional compatibility between the stent system and the vasculature.
• Determine the relationship between the stent diameter and the balloon inflation pressure.
• Determine the length to diameter relationship of the stent.
• Measure the unconstrained length of a self-expanding stent.
• Measure the wall thickness of a stent.
• Determine the percentage by which the diameter of a stent decreases from its expanded diameter, while still on the delivery balloon, to its relaxed diameter, after deflating the balloon.
• Determine the free or open area of any uncovered region of the implant.
• Evaluate the difference between the diameter of the implant and those of the proximal and distal ends of the balloon, when the implant is released under the maximum recommended inflation pressure.
• Measure the stent systems dimensions for verification of design specifications.
• Balloon Inflation to Deflation Time: Measure the time required to inflate the balloon to the maximum recommended inflation pressure, volume or diameter as well as the time required to deflate the balloon.
• Force to Deploy: Determine the force to deploy a self-expanding stent.
• Recoil Testing: Quantify the percentage by which the diameter of a stent decreases from its expanded diameter, while still on the delivery balloon, to its relaxed diameter, after deflating the balloon.
• Radial Force Testing: Measure the force exerted by a self-expanding stent.
• Rated Burst Pressure (RBP) of Balloon
• Dislodgement Force Testing: Determine the force required to pull off the crimped implant from the non-expanded balloon.
• Profile Effect/Flaring: Evaluate the possible implant radial detachment from its balloon at the proximal and distal ends, during the passage through simulated arterial curvature.
• Bond Strength Testing: Determine the bond strength and torsional bond strength of the joints and/or fixed connections of the delivery system.
• Pushability Testing: Evaluate the ease of advancing the delivery system to the model.
• Trackability Testing: Evaluate the ability of the delivery system to track over a guidewire during insertion around bends in the model.
• Torquability Testing: Evaluate the ability to transmit torque from the proximal end to the distal end of the catheter.
• Axial, Bending, and Torsional Durability Testing: Evaluate aspects of the long-term dimensional and structural integrity of vascular and peripheral implants under cyclic axial, bending, torsional, and radial loading conditions.
• Flexural Testing: Quantitatively characterize balloon-expandable stent and stent system flexibility using three-point bending procedures.
• Fatigue Testing
• Pulsatile durability of vascular stents: Verifies the fatigue life of vascular prostheses such as coronary and peripheral stents and bifurcated devices under simulated physiological loading conditions.
• Rated fatigue testing of balloon: Evaluate the ability of the balloon to withstand repeated inflation cycles.
• Crush Resistance Testing: Determine the load/deformation characteristics of the stent.
• Kink Resistance Testing: Determine the minimum radius at which the deployed stent can be flexed without kinking or exhibiting a diameter reduction of greater than 50%.
• Migration Resistance Testing
• Longitudinal Tensile Strength
• Integral Water Permeability
• Water Entry Pressure
• Fabric Water Permeability
• Corrosion Assessment
• Stent corrosion resistance testing
• Catheter corrosion resistance testing

STEMart provides trusted mechanical testing according to ISO, ASTM standards and FAD guidance for vascular implants including endovascular prostheses, vascular stents and vena cava filters. We also develop custom test methods specific to novel and unique technologies. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.