Stent Graft Testing and Vascular Prosthesis Testing
Diseased vessels can be repaired or replaced using stent grafts or vascular prosthesis to resume normal blood flow or to prevent a damaged area from rupturing. A number of methods are used to ensure these devices demonstrate safety, efficacy, and quality, while performing according to their intended use and labeling. We offer comprehensive stent grafts or vascular prosthesis testing services in accordance with ISO standards, ASTM Standards, FDA guidance documents, and the latest peer reviewed research.
ViVitro Labs is a leader in providing standardized as well as customized test methods for cutting edge or novel stent graft or vascular prosthesis designs.
Analysis and Computational Modeling
ViVitro Labs provides a large array of computational modeling tools, such as Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), Fluid-Structure Interaction (FSI) that can be used to assess the impact of anatomical and physiological boundary conditions on the design of a medical devices.Learn more
Burst Strength - Balloon Method
Burst Strength - Probe Method
Graft to Stent Attachment Strength
Migration Resistance - Fixation Effectiveness
Porosity - Microscopic
Pressurized Internal Diameter
Radial Force Measurement
Test specimens are exposed to X-Ray levels necessary for the imaging system and the product or material. Digital analysis method is used to produce the images in accordance with the equipment manufacturer’s instructions. Radiopacity of the device is determined by qualitatively comparing X-ray image(s) of a test sample and a user-defined standard with or without the use of a body mimic.Learn more
Relaxed Internal Diameter
Simulated Use Pre-conditioning
Simulated Use Testing Under Pulsatile Flow
Suture Retention Strength
Tensile Strength - Circumferential
Tensile Strength - Longitudinal
Longitudinal Tensile Strength – A sample of the prosthesis in its tubular form is placed with its ends in suitable jaws. It is then stretched at a uniform rate until the yield and/or break point is reached.Learn more
Uniformity of Expansion / Dog Boning Effect
Water Entry Pressure
Commonly tested devices include stent grafts, vascular prostheses, tubular vascular graft, vascular patches. These devices may be tubular, bifurcated, branched, or tapered . These devices may be manufactured from synthetic textile ( knitted, woven), synthetic non-textiles ( extruded polymer, expanded polymer), biological tissues (xenograft, human tissues with and without viable cells), compound, composite, or coated.
ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
ViVitro Labs provides vascular prothesis testing services such as visual inspection, permeability, integral water permeability/leakage, porosity, water entry pressure , water permeability, circumferential tensile strength, diaphragm pressurized burst strength, longitudinal tensile strength, pressurized burst strength, probe burst strength, strength after repeated puncture, relaxed internal diameter, pressurized internal diameter, wall thickness, suture retention strength, kink diameter/radius, and dynamic radial compliance.
ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ViVitro Labs provides stent graft testing services such as resistance to kinking (flexibility), permeability, integral water leakage, porosity, water entry pressure, water permeability, dimensional verification of the endovascular prosthesis, implant length to diameter relationship, recoil, burst strength, factory seam strength, longitudinal tensile strength, strength after repeated puncture, and strength of the connection(s) between the graft material and a discrete fixation.