Stent & Stent Graft Testing Services

Elements testing capabilities span the full range of endovascular devices, from drug-eluting and bioresorbable stents to vascular grafts and complex intravascular devices. We specialize in devices for various anatomical locations, including peripheral stents for superficial femoral artery (SFA) applications and larger devices like abdominal aortic aneurysm implants. Our testing accommodates varying device dimensions, configurations, and vessel interactions.

We deliver comprehensive testing across multiple parameters to validate your device performance. Our testing suite includes:

Core durability testing:

• Pulsatile durability with cyclical pressure pulses simulating 10 years of implantation
• Axial fatigue for tension and compression
• Crush resistance testing
• S/N curve generation to monitor load and defect failures, helping characterize device durability

Performance measurements:

• Dimensional analysis
• Elastic recoil assessment
• Radial force measurements

Vascular graft-specific testing:

• Longitudinal tensile strength
• Circumferential tensile strength
• Burst strength evaluation
• Suture retention testing

Pulsatile Durability Testing

Axial Fatigue Testing

• Crush Resistance Testing
• S/N Curve Generation

Bending and Torsion Durability Testing

Torsion Fatigue Testing

Vascular Graft Testing

• Longitudinal Tensile Strength
• Circumferential Tensile Strength
• Pressurized Burst Strength
• Diaphragm Pressurized Burst Strength
• Probe Burst Strength
• Strength After Repeated Puncture
• Suture Retention Strength
• Dynamic Radial Compliance

We also offer several additional stent testing services, including:

• Dimensional attributes such as deployed diameter, stent length, crossing profile, strut and bridge thickness, percent solid area and delivery system dimensions per ASTM F2081
• Intrinsic elastic recoil per ASTM F2079
• Displacement force and dislodgment force as part of stent securement evaluation per ASTM F2394
• Tension testing of nickel-titanium superelastic materials by pulling to 6% strain, unloading to less than 7 MPa, and then pulling to failure per ASTM F2516
• Three-point bend testing to assess stent bending flexibility per ASTM F2606
• Radial force measurements per ASTM F3067, ISO 25539-1 and ISO 25539-2
• Leakage at seal zone, migration resistance, separation force from overlapping prostheses, crush resistance and local compression per ISO 25539-1 and ISO 25539-2

We employ multiple inspection methods throughout the testing process to provide comprehensive performance documentation for your regulatory submissions. Our capabilities include:

Advanced inspection methods:

• Digital microscopy with 8x lenses and high-resolution imaging

• Endoscope analysis

• High-speed video capture at 1000 frames per second

• Strobe light analysis

Additional testing:

• Media sampling for nickel ion release

• Particulate testing

• Visual inspections performed at regular intervals

Pulsatile Durability Testing (ASTM F2477, ISO 25539-1, ISO 25539-2, ISO 7198):
We subject devices to cyclical pressure pulses at physiological conditions (80-120 mmHg, 72 BPM) to simulate in vivo strains in precisely matched mock vessels that replicate vessel compliance. This helps evaluate how devices will perform under dynamic conditions over time..

Axial Fatigue Testing (ASTM F2942, ISO 25539-1, ISO 25539-2):
Axial testing simulates physiological loading in tension or compression, with two key tests:

• Crush Resistance Testing: Evaluates the device's ability to resist permanent deformation or cyclic fatigue, simulating 10 years of implantation, especially useful for studying overlapping vessel interactions.

• S/N Curve Generation: Fatigue testing to monitor load and detect failures, helping to characterize device durability.

Bending and Torsion Durability Testing (ASTM F2942, ISO 25539-2):
These tests simulate clinical scenarios like natural gait motion and other bending or torsional loads, particularly for peripheral stents. We use a variety of fixtures to accommodate different bending test configurations.

Torsion Fatigue Testing (ASTM F2942, ISO 25539-1, ISO 25539-2):
Simulates torsional loading in various anatomical locations. Multi-axial loading fixtures can apply simultaneous tension/compression, bending, and torsion, tailored to simulate real-world clinical conditions.

Vascular Graft Testing (ISO 7198):
Comprehensive testing for vascular grafts includes:

• Tensile Strength: Measures both longitudinal and circumferential tensile strength in tubular form.

• Burst Strength: Assesses pressurized burst strength, including diaphragm and probe burst tests.

• Puncture Resistance: Evaluates strength after repeated puncture with dialysis needles.

• Suture Retention: Assesses the ability to retain sutures.

• Dynamic Radial Compliance: Tests the graft's response to dynamic conditions.

Specialized durability testing
Our custom fixtures accommodate a comprehensive range of bend tests to simulate complex physiological conditions. We offer:

Advanced bend testing capabilities:

• Pure bending

• Cantilevered bending

• Combined pure and cantilevered bending

• Constant radius testing

• Compression testing

• Shear-induced bending

Our multi-axial loading fixtures apply tension/compression, bending, and torsion simultaneously to replicate real-world conditions.

Our advanced testing systems simulate physiological conditions and capture detailed performance data. We maintain state-of-the-art equipment including:

Testing systems:

• Precisely matched mock vessel setups with controlled compliance
• Multi-axial loading fixtures
• High-speed stent and graft testers capable of accelerated testing

Inspection equipment:

• Advanced microscopy systems with 8x lenses and 30fps digital cameras
• Endoscopic inspection devices
• Specialized bend fixtures

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.