With years of experience testing endovascular devices, heart valves and pacemaker leads, our cardiovascular device testing programs are among the best in the industry. Our Engaged Experts assist with test design, product feasibility, protocol development and test inspections.

The medical device industry changes rapidly with the introduction of new materials and device designs, and cardiovascular devices are no exception. Our laboratories are well equipped with state-of-the-art technology, including Series 9000 Stent/Graft Testers and latest generation axial test instruments for accelerated cardiovascular device fatigue testing. 

The Element advantage 

Element’s cardiovascular device testing helps companies prepare products for regulatory compliance, including FDA 510K submissions and regulatory submissions to international markets. 

Our trusted medical device testing allows your company to mitigate risk knowing that we are working diligently to help ensure your success and bring a safe product to market. For more information about our cardiac & endovascular device testing or to request a quote, contact us today

Our Cardiovascular Device Testing Services  

Cardiac & Endovascular Device Testing

Pulsatile Durability Testing

Designed to demonstrate the long-term integrity of devices under mechanical fatigue, pulsatile durability typically simulates ten years of post-implantation use under accelerated conditions.

Key Facts

Test Instruments

ElectroForce Stent Graft Testers

Loading Mode

Radial Strain

Capacity

Up to 16 Silicone Mock Vessels

Environment

Heated Saline

Test Frequency

Up to 60 Hz

Number of Cycles

Typically 400 M to mimic 10 years of Implantation

Inspection Equipment

Microscope, Endoscope, High Speed Video

Devices typically evaluated under pulsatile durability include: Vena cava filters During testing, devices are placed in mock arteries mounted on a stent/graft tester under simulated physiological conditions and pulsed to create a dynamic radial strain. We generally test to ASTM F2477-07, ISO 25539-1 and ISO 7198.

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cardiac & Endovascular device testing

Heart Valve Testing

Heart valve testing evaluates the structural integrity of percutaneous and transcatheter heart valves by replicating in vivo conditions through mechanical fatigue.

Key Facts

Test Instruments

ElectroForce 3200 and 3300 Testers

Loading Mode

Tension/Compression

Capacity

Up to 15 Samples

Environment

Heated Saline

Test Frequency

Up to 50 Hz

Number of Cycles

Typically 600 M to mimic 15 years of Implantation

Inspection Equipment

Microscope, Endoscope, High Speed Video

Full devices and stent strut or support structures are tested under mechanical fatigue to demonstrate device integrity for a minimum of 15 years post-implantation.

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Cardiac & Endovascular Device Testing

Simulator Lead Testing

Stimulator lead testing subjects devices to flex fatigue and distal tip buckling, representing a minimum of 10 years post-implantation service life.

Key Facts

Test Instruments

Lead Torsion/Flex and Instron Pull Testers

Loading Mode

Torsion, Flex, Tensile

Capacity

Up to 8 Samples

Environment

Ambient Air

Test Frequency

Typically 2 Hz

Number of Cycles

Typically up to 100K

Inspection Equipment

Microscope, Electrical Continuity

We provide several types of stimulator lead testing, including Pacemaker/defibrillator leads, helicoil/tines, spinal cords and neurostimulator leads testing. Pacemaker/defibrillator lead and helicoil/tine testing focuses on mechanical flex and bending that simulates in vivo conditions per FDA guidance documents for pacemaker leads and percutaneous transluminal coronary angioplasty catheters. While, spinal cord and neurostimulator lead testing uses flex and bending to mimic intended use conditions.

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cardiac & endovascular device testing

Electrochemical Corrosion Testing

Element’s electrochemical corrosion testing services evaluate the corrosion resistance of implantable devices. 

Key Facts

Test Instruments

Potentiostats

Loading Mode

Cyclic Potentiodynamic Polarization

Capacity

1 Sample per Corrosion Cell

Environment

Heated Water or Saline

Inspection Equipment

Microscope, Scanning Electron Microscope

Our labs offer cyclic potentiodynamic polarization testing per ASTM F2129 to determine the corrosion susceptibility of medical devices.

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More Cardiovascular Device Testing More Cardiovascular Device Testing
  • Acute Particulate Characterization
  • Axial and Torsional Fatigue Testing
  • Bending and Torsional Durability Testing
  • Gait Motion Durability
  • Nickel Ion Leaching
  • Radial Force Testing
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