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Home >> Products >> Dynamic Fatigue Testing Machines >> Medical Implants Fatigue Test >> Vascular Stent Radial Pulsatile Fatigue Testing System

Vascular Stent Radial Pulsatile Fatigue Testing System

Model: UTCA-VSRD6, ISO 25539, ASTM F2477.

UTCA-VSRD6 Radial Pulsatile Accelerated Durability Tester is designed to perform accelerated pulsatile durability testing on vascular implants such as stents or valve frames, in accordance with relevant requirements of ISO 25539 and ASTM F2477. The system includes six test stations, utilizing a closed-loop feedback control system. Its innovative design employs a "'single motor to synchronously drive dual diaphragms" that push fluid at high frequency from both sides of the mock vessel. This action simulates cardiac pulsations and the resulting cyclic radial loading on the samples under test. The dynamic outer diameter of a selected mock vessel is measured in real-time by an optical laser micrometer. The tester supports various stent types and features an easy-to-adjust mechanism to accommodate mock vessels of different lengths. The entire process (from control and acquisition to computation, analysis, and recording) is managed by our proprietary, self-developed test software.

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General Introduction

A qualified vascular stent typically requires a design life that covers the patient's life span of 10 years or even several decades. If tested in real time, manufacturers would have to wait ten years to develop a new product, which is obviously impractical.

Therefore, the core mission of Radial Pulsatile Fatigue Testing System is through a highly precise control system, accelerates the human daily heart rate of about 100,000 beats to several thousand or even tens of thousands of beats per minute. In just a few weeks or months, it can complete a fatigue test equivalent to 10 years in the human body (about 400 million heartbeat cycles).

It does not only verify whether the stent will fracture but also observes whether it will deform, collapse, or whether the drug coating on its surface will peel off during prolonged pulsation. Placing the stent into a mock blood vessel and then, like inflating a balloon, making it continuously expand and contract.

Application: Applicable to vascular stents, valve frames, and surgical stents.

Key Features

Main features
Standard

1), The innovative "single motor to synchronously drive dual diaphragms" technology ensures bidirectional synchronization and high fluid displacement capacity.

2), The vertical orientation ensures exceptional stability during high-frequency operation and facilitates easy access for optical diameter measurements on the mock vessel.

3), The vertical structure and diaphragm-driven fluid system allow for easy de-aeration and enable bubble-free operation.

4), Specialized TEST software features an intuitive workflow that guides the user through the entire testing process, ensuring compliance with standard requirements.

ASTM F2477: Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses

ISO 25539-1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

ISO 25539-2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

ISO 25539-3: Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters.

Main Technical Specification

Model	UTCA-VSRD6
Sample Capacity	Up to 6, Custom Channel Available
Mock Vessel Size	Diameter Range: 2 to 50mm
Mock Vessel Size	Max. Length: 360mm
Operation Modes	Autopilot Stroke and Fixed Stroke
Drive Waveform	Sine
Stroke volume	Up to 80mL
Allowable Frequency	1.2 to 80Hz, Suggested 20 to 50Hz
Test Medium	Purified Water, Saline Solution or Phosphate Buffered Saline
Fluid Temperature Control	Room Temperature to 42℃, ±2℃
Pressure Range and Accuracy	-100 to 700mmHg, ±2mmHg
Diameter Measure Capacity	Optical Micrometer; Up to 65mm, ±0.5μm, Sampling Rate 2400Hz
Others	Common Accessories, Fixture Customization Available

Standard

ASTM F2477 Test for in-vitro Pulsatile Durability Testing of Vascular Stents –

ASTM F2477 designed to evaluate the long-term fatigue durability and radial cyclic deformation resistance of vascular implants under simulated physiological pulsatile loading conditions. It is crucial for simulating the cyclical stresses these medical devices endure inside human blood vessels.

ASTM F3036 Testing of Absorbable Stents –

ASTM F2942 specifies in vitro test methodologies to evaluate the cyclic durability of vascular stents under non-radial mechanical deformations (axial, bending, and torsion) that occur in vivo due to musculoskeletal motion, breathing, or cardiac activity. include Axial, bending, torsional, Pulsatile Durability, Radial Loading etc., test.

ASTM F3067 Radial Loading Test of Vascular Stents –

ASTM F3067 establishes in vitro test frameworks to characterize the radial mechanical performance of balloon-expandable vascular stents and self-expanding vascular stents. It quantifies three key indicators: radial strength and collapse pressure for balloon-expandable stents, and chronic outward force (COF) for self-expanding stents.

ASTM F2606 Three-Point Bending Test for Balloon-Expandable Vascular Stents and Stent Systems –

ASTM F2606 defines quantitative three-point bending procedures to characterize the bending flexibility and stiffness of balloon-expandable vascular stents and stent systems (pre-deployment and deployed states). It is a critical testing protocol in the biomedical engineering field. Since vascular anatomies are naturally curved and tortuous, a stent must be flexible enough to navigate through the delivery pathway (trackability) and conform to the vessel's curvature once deployed without causing vascular trauma . This standard provides the guidelines to measure these mechanical properties accurately.

ASTM F2942 Vascular Implants Axial, bending, torsional and compression durability testing –

ISO 17137 Test Methods of cardiovascular absorbable implants –

Based on the ISO/TS 17137 standard the evaluation of mechanical properties is a critical part of the design and safety validation process. Mechanical Evaluation like tension, radial force, Cyclic Fatigue Durability like constant pulsing. Because absorbable implants lose their structural integrity over time through degradation, their mechanical performance must be assessed not just at the time of implantation, but throughout their intended functional lifetime.

ISO 12417-1 Test Methods for Cardiovascular implants and extracorporeal systems –

ISO 12417-1 specifies requirements for Vascular Device-Drug Combination Products (VDDCPs) (drug-eluting stents, drug-coated balloons, drug-bearing vascular grafts, etc.). It mandates mechanical tests for the device part (DP) (to verify structural/functional integrity) and a suite of drug-related, physicochemical, biological, and clinical tests. Mechanical performance must comply with device-specific standards (ISO 25539-2, ISO 10555-4, ISO 7198) and remain unaffected by the drug-containing part (DCP).

ISO 7198 Mechanical Tests and Other Evaluations for Vascular Implants –

ISO 7198 specifies test and performance requirements for tubular vascular grafts and vascular patches (surgical vascular prostheses). It defines mechanical tests (with full method/equipment/sample details) and other physicochemical, biological, dimensional, preclinical/clinical tests.