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An In Vitro Hemodynamic Loop Model to Investigate the Hemocytocompatibility and Host Cell Activation of Vascular Medical Devices
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Development of a large diameter in vitro flow loop thrombogenicity test system.

Carlos Serna1, Anna Parrish1, Mehulkumar Patel1

  • 1Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Artificial Organs
|September 2, 2024
PubMed
Summary

A new 9.5-mm inner diameter (ID) in vitro flow loop system effectively differentiates medical device material thrombogenicity. This larger system, using dynamic roller occlusion and donor-specific anticoagulation, aids in developing standardized testing methods.

Keywords:
biomaterialsblood flow loopin vitro testingocclusion settingplateletsroller pumpsthrombosis

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Area of Science:

  • Biomaterials Science
  • Medical Device Engineering
  • Hemocompatibility Testing

Background:

  • A larger in vitro flow loop thrombogenicity test system with 9.5-mm inner diameter (ID) tubing was developed.
  • This system expands upon a previously established 6.4-mm ID system to accommodate a wider range of medical device sizes.

Purpose of the Study:

  • To evaluate the efficacy of the larger 9.5-mm ID in vitro flow loop system.
  • To assess its ability to differentiate materials with varying thrombogenic potentials.

Main Methods:

  • Four cardiopulmonary bypass roller pumps and a novel dynamic roller occlusion setting method were used.
  • Five materials (PTFE, silicone, 3D-printed nylon, latex, BUNA) were tested using heparinized bovine blood at 20 rpm for 1 hour.
  • Thrombogenicity was assessed by measuring thrombus surface coverage, weight, and platelet (PLT) count reduction.

Main Results:

  • The 9.5-mm ID system successfully differentiated highly thrombogenic materials (latex, BUNA) from thromboresistant PTFE.
  • Silicone and 3D-printed nylon showed intermediate thrombogenicity, with less thrombus formation than latex/BUNA but more than PTFE (p < 0.05).

Conclusions:

  • The 9.5-mm ID test system effectively differentiates material thrombogenic potentials with proper settings.
  • This system is part of an interlaboratory study to standardize in vitro dynamic thrombogenicity testing for medical devices.