With decades of experience testing stents, heart valves and pacemaker leads, we have led the industry in implantable cardiovascular device testing. Our Engaged Experts are ready to assist with your most challenging testing applications.
The cardiovascular medical device industry changes rapidly with the regular introduction of new materials, device designs, and regulatory requirements. Element supports device manufacturers throughout the validation process, from test design and protocol development to product feasibility testing and inspection.
Our laboratories are well equipped with state-of-the-art technology, including a wide array of Series 9000 Stent/Graft Testers and latest generation ElectroForce and ElectroPuls axial test instruments for accelerated cardiovascular device fatigue testing.
Industry-leading experts in cardiovascular device testing
We provide a comprehensive preclinical test suite for cardiovascular devices by combining our expertise and deep understanding of device testing with the most advanced test instruments and inspection methods.
Our specialty is cardiovascular device fatigue testing. Stents, grafts, occluders, neurostimulator leads, bioresorbable polymeric and metal devices, balloons, guidewires, catheters, and many other implantable endovascular prostheses are routinely tested in our laboratories.
Durability testing is a key requirement for regulatory submissions; however, there are many additional tests that regulatory bodies require, including characterization of coatings and particulates, corrosion resistance evaluation, and nickel ion release.
For more information about our cardiac & endovascular device testing or to request a quote, contact us today.
Our Cardiovascular Device Testing Services
Stent & Graft Testing
Our cardiovascular device experts offer a comprehensive suite of stent and graft testing including pulsatile durability, fatigue, visual inspection, and custom test methods.
Heart Valve Device Testing
Element routinely characterizes heart valve prostheses using test methods specific to the devices and their design.
ISO 10555 Catheter Testing
ISO 10555 outlines general requirements for testing intravascular sterile use catheters. We offer comprehensive testing services for catheters and balloons according to industry recommendations and standards.
Occluder & Closure Device Testing
Element's occluder device testing services assess durability with low and high cycle testing to help bring safe products to patients.
Pacemaker Lead Testing
Our cardiovascular device testing experts understand how crucial it is that pacemaker leads perform as intended to keep patients safe and improve their quality of life.
ISO 11070 Guidewire Testing
ISO 11070 outlines general requirements for testing sterile single-use intravascular introducers, dilators and guidewires.
Coating & Particulate Testing
Minimizing particulates and increasing coating lubricity can be two competing requirements, which presents challenges for device manufacturers. Our experts evaluate coatings and particulates intending to bring safe and reliable products to market.
Nickel Ion Release Testing
Element evaluates nickel ion release from nitinol and other nickel-rich medical devices to help medical device manufacturers characterize nickel ion leaching.
Silicone Mock Vessels
Our cardiovascular device testing experts have extensive experience designing custom mock vessels for pulsatile fatigue testing and other test methods for devices such as stents, occluders, and heart valves.
Tips for Medical Device Testing
Our medical device testing experts provide guidance on how to determine the size and number of samples, in addition to test levels, systems and protocol.
Our experts undertake a wide range of projects for medical device and pharmaceutical manufacturers, from pathogen and bioburden testing to endotoxin and cytotoxicity analyses.
Test Protocol for Medical Devices
A protocol and plan will mitigate your risk, prevent confusion, set clear expectations, and preserve the necessary information for future reference and use.
Accelerated Aging Shelf Life Testing
Our shelf life testing can help you determine how climatic & environmental factors like humidity, temperature, and light affect the lifespan and integrity of your products.