Heart Valve Device Testing

Replacement and Repair Devices

Native heart valves with abnormal stenosis or regurgitation may be repaired or replaced in order to resume proper function. A number of methods are used to ensure prosthetic heart valves demonstrate safety, efficacy, and quality, while performing according to their intended use and labeling. We offer comprehensive  heart valve device testing for replacement and repair devices  in accordance with ISO standards, ASTM Standards, FDA guidance documents, and the latest peer reviewed research.

ViVitro Labs is a leader in providing standardized as well as customized test methods for cutting edge or novel heart valve replacement or repair devices.

For catheter based delivery systems see additional tests here.

Heart Valve Testing

Courtesy of Abbott – Portico™ valve

<

Accelerated Wear Testing (AWT)

Study the durability (repeated opening and closing) of a heart valve prosthesis under accelerated conditions.

Learn more
<

Calcification

ViVitro Labs calcification testing is available for cardiovascular devices including prosthetic valves and conduits and other cardiovascular devices that contain tissue, or may be susceptible to calcification.

Learn more
<

Dimensional Attributes

A contactless optical gauging machine is used to measure dimensional attributes of the device.

Learn more
Smartscope
<

Durability Testing (Integrated Durability Assessment)

Durability testing is intended to determine the in-vitro lifetime, the anticipated failure modes, and  potential failure consequences (e.g. immediate total loss of  function or gradual degradation of  function).

Learn more
<

Dynamic Failure Mode (DFM)

Dynamic Failure Mode (DFM) testing is used together with Accelerated Wear Testing (AWT) to provide a  thorough assessment of durability. Since AWT is a “test to success” approach meaning samples are intended to survive the test, DFM testing is a “test to failure” approach which is intended to characterize potential durability-related failure modes.

Learn more
<

Dynamic Migration

A measurement at which pressure of a device begins to migrate under pulsatile flow conditions.

Learn more
<

Effects of device post-dilatation

An assessment of the effects of post-implant dilatation on the leaflets and frame should be conducted if this is an expected use condition to which the (novel) heart valve substitute will be exposed.

Learn more
<

Ex-Vivo Beating Heart

Our ex-vivo beating heart simulator is used to test transcatheter devices when realistic anatomy is required.

Learn more
<

Experimental Flow Field Assessment – Digital Particle Image Velocimetry (DPIV)

Using Digital Particle Image Velocimetry (DPIV),  pulsatile flow conditions in the immediate vicinity of the device can be analyzed to determine the viability of cardiovascular devices meeting regulatory standards. Triggers for disease (such as shear stresses and regions of stagnation) can be quantified with a high degree of accuracy. Advanced methods, including proper orthogonal decomposition, also capture the implicit fluid mechanical phenomenon of interest.

Learn more
<

Experimental Flow Field Assessment – Echo Doppler - Bernoulli’s Equation Verification

The goal of the test is to determine, in vitro, for a specific artificial cardiac valve the value of the coefficient K in the Bernoulli equation, ΔP = K (Vd2 – Vp2).

Learn more
<

Pulsatile Flow Testing - Hydrodynamic Performance

Hydrodynamic Performance Pulsatile Flow Testing – Forward flow and regurgitant performance of the device will be assessed under physiological pulsatile flow conditions. Key indicators of valve performance such as Effective Orifice Area (EOA) and regurgitant fraction (RF) are determined.

Learn more
<

Radiopacity

Test specimens are exposed to X-Ray levels necessary for the imaging system and the product or material. Digital analysis method is used to produce the images in accordance with the equipment manufacturer’s instructions. Radiopacity of the device is determined by qualitatively comparing X-ray image(s) of a test sample and a user-defined standard with or without the use of a body mimic.

Learn more
<

Real-Time Wear Testing (RWT)

Real-time wear testing (RWT) is intended to match physiological loading conditions as closely as possible as to what would be obtained in a real patient. Due to the viscoelastic nature of some materials, Accelerated Wear Testing may actually under test devices, so RWT can be used to identify frequency dependent failure modes.

Learn more
<

Scanning Electron Microscopy (SEM) and Optical Inspection

<

Sewing Ring Integrity

A measure of the resistance to sewing ring dehiscence. Failure may result from sutures, suture retention failure, fabric tensile strength failure, fabric weave failure, or fabric seam failure.

Learn more
<

Simulated Use Pre-conditioning

Before conducting other evaluations, test samples should undergo all the steps a finished device would go through before being implanted in the patient.

Learn more
<

Simulated Use Testing Under Pulsatile Flow

Devices can be subjected to various physiological pulsatile flows and pressures.

Learn more
<

Steady Flow Testing - Hydrodynamic Performance

Hydrodynamic Performance Steady flow testing determines the forward and reverse flow performance characteristics of a valve in a simple and highly controlled manner. While no formal acceptance criteria exists for steady flow testing, it can be useful in confirming results of pulsatile flow testing.

Learn more
<

Steady Flow Testing - Stent Post Deflection

The deflection of the stent lateral struts (post) is measured when subjected to different back-pressures.

Learn more
ISO 5840-1:2021 Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

ViVitro Labs provides heart valve testing services such as hydrodynamic performance assessment (steady flow testing, steady), structural performance assessment, implant durability assessment (accelerated wear testing (AWT), dynamic failure mode testing (DFM), and real-time wear testing (RWT)), component corrosion assessment (pitting corrosion, crevice corrosion, galvanic corrosion, corrosion fatigue, fretting (wear) and fretting corrosion) , human factors/usability assessment, and implant thrombogenic and haemolytic potential assessment (digital particle image velocimetry (DPIV)

ISO 5840-2:2021 Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

ViVitro Labs provides surgical heart valve testing services such as hydrodynamic performance assessment (pulsatile flow), cavitation, visibility (radiopacity), sewing ring integrity, stent creep, static pressure burst test, calcification, particulate generation, effects of device post-dilatation, leaflet impingement force, leaflet escape force, sewing ring push-off, sewing ring torque, device migration resistance

ISO 5840-3:2021 Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

ViVitro Labs provides transcatheter heart valve testing services such as: hydrodynamic performance assessment (pulsatile flow), Device migration resistance, Implant foreshortening, Crush resistance, Recoil, Radial resistive force (RRF), Chronic outward force, Visibility (radiopacity), Simulated use, Stent creep, Static pressure; “burst” test, Calcification, Particulate generation, Effects of device post-dilatation, Expansion uniformity, Bailout option evaluation, Intentional cracking of a pre-existing prosthesis, Valve in Valve (ViV), Valve in Ring (ViR)

For catheter based delivery systems see additional tests here.

ISO 5910:2018 Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices

ViVitro Labs provides transcatheter heart valve repair device testing services such as: functional performance assessment (steady back-flow leakage testing, Pulsatile-flow testing), device structural performance assessment, device durability assessment (accelerated wear testing (AWT), dynamic failure mode testing (DFM), and real-time wear testing (RWT)), device corrosion assessment, visibility (radiopacity), simulated use assessment, human factors / usability assessment

For catheter based delivery systems see additional tests here.

 

Devices Tested include:

Transcatheter Aortic Valve Implantation (TAVI) [also known as transcatheter aortic valve replacement (TAVR)]

Transcatheter Mitral Valve Implantation (TMVI) [also known as transcatheter mitral valve replacement (TMVR)]

Transcatheter Pulmonary Valve Implantation (TPVI) [also known as transcatheter pulmonary valve replacement (TPVR)]

Transcatheter Tricuspid Valve Implantation (TTVI) [also known as transcatheter tricuspid valve replacement (TPVR)]

Transcatheter valvular repair devices including: (edge to edge, direct annuloplasty, indirect annuloplasty, annular plication, chordal replacement, coaptation enhancement, ventricular remodeling, and other novel techniques)

Join over 5000 cardiovascular device professionals who receive our testing and engineering insights and tips every month.