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.

Stent Graft Testing and Vascular Prosthesis Testing

Courtesy of Perouse Medical

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Burst Strength

Pressure at which the prothesis bursts.

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Burst Strength - Balloon Method

Pressure at which the prothesis bursts using a balloon to seal devices with high permeability which may not be able to hold pressure on their own.

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Burst Strength - Probe Method

A probe is traversed through the specimen until it ruptures.

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Dimensional Attributes

A contactless optical gauging machine is used to measure dimensional attributes of the device.

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Smartscope
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Graft to Stent Attachment Strength

Evaluate the strength of the connection of the graft to the stent structure.

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Kink Diameter

Determination of the radius of curvature required to begin “kinking” a vascular prosthesis.

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Migration Resistance - Fixation Effectiveness

Force required to displace the prosthesis within a mock artery.

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Porosity - Microscopic

Measure the area of the voids and/or the area of the material on the sample prosthesis by means of measurements made on a scanning electron micrograph or optical micrograph.

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Pressurized Internal Diameter

Determination of internal diameter under simulated physiological conditions of the same order of magnitude as the arterial blood pressure: 120 mmHg.

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Radial Force Measurement

The force-diameter curves of stent like structures are determined while loading and unloading the sample according to a specified profile.

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crush resistance
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Radiopacity

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.

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Relaxed Internal Diameter

The relaxed internal diameter of the test device is measured.

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Simulated Use Pre-conditioning

Before conducting other evaluations, test samples should undergo all the steps a finished device would go through before being implanted in the patient.

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Simulated Use Testing Under Pulsatile Flow

Devices can be subjected to various physiological pulsatile flows and pressures.

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Suture Retention Strength

Determination of the force necessary to pull a suture from the prosthesis or cause the wall of the prosthesis to fail.

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Tensile Strength - Circumferential

Circumferential Tensile Strength – Sample prosthesis in its tubular form is placed onto two rounded pins and stretched at a uniform rate until the yield and/or break point is reached.

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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.

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Uniformity of Expansion / Dog Boning Effect

Stent expansion uniformity: Difference between the largest and smallest diameter measurement on a single stent deployed to its labelled diameter.

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Usable Length

The usable length of the prosthesis is measured under a tensile load.

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Wall Thickness

Determination of the thickness of the wall of the prosthesis under no load or minimal load. A microscope with direct and diffuse illumination is used.

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Water Entry Pressure

Pressure at which water is observed on the external surface of a pressurized sample.

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Water Permeability

Determination of the rate of flow of water through a given area of the sample or the entire prosthesis under a given hydrostatic pressure.

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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.

 

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