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Calcification

(Heart Valve)

Artificial heart valves must remain durable and biocompatible throughout years of continuous operation. One of the most critical long-term risks is calcification — the deposition of calcium salts on valve leaflets and supporting structures. Calcification can impair valve flexibility, increase regurgitation, and ultimately lead to device failure. Rigorous testing is therefore essential to validate valve durability and patient safety.

At our laboratory, we conduct calcification testing under internationally recognized protocols, providing manufacturers with the data needed to demonstrate reliability and compliance.

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  • Accelerated In Vitro Models:
    Simulation of physiological conditions to evaluate calcium deposition over time.

 

  • Quantitative Analysis:
    Measurement of mineral accumulation, leaflet stiffening, and changes in hydrodynamic performance.

 

  • Material Evaluation:
    Assessment of biomaterials, coatings, and design features that influence calcification resistance.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 5840 and related standards to support FDA, CE, and global approvals.
  • Patient Safety:
    Preventing calcification ensures valves maintain proper function and reduce risks of reoperation.

 

  • Performance Assurance:
    Long-term durability testing confirms valves deliver consistent hydrodynamic performance.

 

  • Design Optimization:
    Data-driven insights guide improvements in biomaterials and anti-calcification strategies.

 

  • Accelerated Market Access:
    Compliance with international standards streamlines regulatory pathways and builds confidence with clinicians.

 

By combining advanced test systems, precision analytics, and strict adherence to global standards, we help manufacturers validate the long-term safety and reliability of their artificial heart valve prostheses. Partnering with us means confidence in compliance, innovation, and patient protection.

Workflow

How we work:

A clear, three-step workflow—ensures a reliable, data-driven progress.

Feasibility
Study

Performance
Charaterization

Full approval-
relevant studies

Your journey with ac.biomed:

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1.
Service Request

2.
Information Provision

3.
NDA

1.
Service Request
2.
Information Provision
3.
NDA
4.
Service Requirements
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4.
Service Specification

5.
Quotation

6.
Order

7.
Order Confirmation
5.
Service Specification
6.
Quotation
7.
Order
8.
Order Confirmation
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8.
Test Plan

9.
Test Plan Approval

10.
Test Execution

11.
Test Report
9.
Test Plan
10.
Test Plan Approval
11.
Test Execution
12.
Test Report

Our strengths

“Outstanding service, reliable support, genuine customer closeness and open communication – this is our shared path to success.”

Quality

ac.biomed provides
quality services.

Certificate
ISO 17025
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Certificate
ISO 9001:2015
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Move forward
with ac.biomed

We want to hear from you. Whether you‘re a prospective client, a professional interested in joining our team, or simply someone interested in our work, send us a note.

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