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Thrombogenicity

(Heart Valve)

Artificial heart valves must not only deliver reliable hydrodynamic performance but also demonstrate biocompatibility with blood. One of the most critical safety concerns is thrombogenicity — the tendency of a valve to promote clot formation. Excessive thrombosis can impair valve function, increase the risk of embolism, and compromise patient outcomes. That’s why ISO 5840 requires rigorous thrombogenicity testing as part of valve validation.

At our laboratory, we conduct thrombogenicity evaluations in full compliance with ISO 5840, ensuring every valve is assessed under clinically relevant conditions to meet global regulatory expectations.

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  • Simulated Physiological Conditions:
    Evaluation under pulsatile flow, shear stresses, and pressure gradients that replicate cardiac cycles.

 

  • Quantitative Assessment:
    Measurement of platelet activation, fibrin deposition, and clot formation to determine thrombogenic potential.

 

  • Design Optimization:
    Data-driven insights into leaflet geometry, hinge mechanisms, and biomaterial selection to minimize clot risk.

 

  • Regulatory Documentation:
    Comprehensive reporting aligned with ISO 5840 requirements to support FDA, CE, and international approvals.
  • Patient Safety:
    Reducing thrombosis risk prevents complications such as stroke, embolism, and valve failure.

 

  • Performance Assurance:
    Reliable valve function depends on maintaining unobstructed flow without clot formation.

 

  • Accelerated Market Access:
    ISO 5840 compliance streamlines regulatory pathways and builds confidence with clinicians and stakeholders.

By combining advanced test systems, expert analysis, and strict adherence to ISO standards, we help manufacturers validate the thrombogenicity profile of their artificial heart valves. 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.

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ISO 17025
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Certificate
ISO 9001:2015
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