Element’s team of engaged experts has extensive expertise in cardiovascular medical device testing. With years of experience testing stents, grafts, occluders, vena cava filters, heart valves and pacemaker leads, our cardiovascular device testing programs are among the best in the industry.
We can assist with all aspects of cardiovascular device testing, including test design, feasibility, protocol development and test inspections. Using Series 9000 Stent/Graft Testers and latest generation axial test instruments, we are well equipped for accelerated medical device fatigue testing.
Element’s team of cardiovascular medical device testing experts helps companies prepare products for regulatory compliance, including FDA 510K submissions and regulatory submissions to international markets.
For more information about our cardiovascular device testing, or to request a quote, contact us today.
Electrochemical Corrosion Testing
Element offers electrochemical corrosion testing to evaluate how metallic implants are affected by the human body. Our labs offer cyclic potentiodynamic polarization testing per ASTM F2129 to determine the extent of corrosion, and to ensure that no harmful effects are produced.
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.
Devices typically tested under pulsatile durability include:
- Coronary stents
- Peripheral stents
- Neural stents
- Endovascular grafts
- Pulmonary stents
- Vena cava filters.
During these tests, devices are placed in mock arteries on a stent/graft tester under simulated physiological conditions and pulsed to create a dynamic radial strain.
Test requirements are outlined in ASTM F2477-07, ISO 25539-1 and ISO 7198.
Heart Valve Testing
Heart valve testing evaluates the structural integrity of percutaneous and transcatheter heart valves by replicating in vivo conditions through mechanical fatigue. 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.
Full device fatigue and stent strut or valve support structure are tested under mechanical fatigue to demonstrate device integrity for a minimum of 15 years post-implantation.
Stimulator Lead Testing
Stimulator lead testing subjects devices to flex fatigue and distal tip buckling, representing a minimum of 10 years post-implantation service life.
We provide several types of stimulator lead testing, including:
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.
Spinal cord and neurostimulator lead testing
Uses flex and bending to mimic intended use conditions.
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