Heart Valve Replacement and Repair

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 these devices demonstrate safety, efficacy, and quality, while performing according to their intended use and labeling. We offer comprehensive heart valve replacement and heart valve repair testing services 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.

Courtesy of Abbott – Portico™ valve

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Accelerated Wear Testing (AWT)

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

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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.

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Dimensional Attributes

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

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Smartscope
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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).

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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.

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Dynamic Migration

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

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Effects of Post-Implant 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.

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Ex-Vivo Beating Heart

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

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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.

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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).

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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.

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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 test sample and a user-defined standard with or without the use of a body mimic.

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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.

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Scanning Electron Microscopy (SEM) and Optical Inspection

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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.

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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.

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Simulated Use Testing Under Pulsatile Flow

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

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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.

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Steady Flow Testing - Stent Post Deflection

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

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