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.

More cost effective and ethical method to assess calcification than animal models.

Test Procedure

Immersing cardiovascular devices in a saturated calcification solution and exposing them to mechanical stresses associated with full opening and closing under normotensive backpressures creates leaflet calcification similar to that observed in vivo.

This method can be useful for evaluating the calcification potential of a novel device when compared against a reference valve or determining the effectiveness of anti-calcification treatments when comparing treated and untreated valves. It can also be useful for identifying regions of the device which are more susceptible to calcification.

Measured Parameters

This test method can be used to quantify the effectiveness of anti-calcification treatment.

The degree of calcification can be quantified using μCT, Spectroscopy, or histology (Von Kossa staining) upon request.

The volume and location of calcium deposits can be determined with μCT. This test can give bulk distribution throughout the valve, or highlight calcium deposit through the thickness of the
tissue depending on the resolution selected.

As a valve calcifies it also becomes increasingly stenotic. Increased gradients across the valve can be characterized by ViVitro with hydrodynamic testing before and after calcification.

Scope

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.

Bioprosthetic heart valves are superior to mechanical valves in hemodynamic performance and do not require lifetime anticoagulation therapy. However, they may succumb to premature tissue calcification, which is triggered by calcific aortic valve disease.

Service Levels

Applicable Standards

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

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

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

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

Related Tests

OLE/QV

Von Kossa staining to detect calcific deposits (shown in black)

3D reconstruction of the calcified heart valve using μCT, the calcium. (Deposits are shown as colored regions. The relatively small degree of calcification demonstrates the effectiveness of anti-calcification treatment. )


ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Accredited by A2LA and Cofrac.

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

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