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research-article

Thrombogenicity Testing of Medical Devices in a Minimally Heparinized Ovine Blood-Loop

[+] Author and Article Information
Kent Grove

American Preclinical Services 8960 Evergreen Blvd, NW Coon Rapids, MN 55433
kgrove@sjm.com

Steve M Deline

American Preclinical Services 8960 Evergreen Blvd, NW Coon Rapids, MN 55433
sdeline@apsemail.com

Tim F Schatz

American Preclinical Services 8960 Evergreen Blvd, NW Coon Rapids, MN 55433
tschatz@apsemail.com

Sarah E Howard

American Preclinical Services 8960 Evergreen Blvd, NW Coon Rapids, MN 55433
showard@apsemail.com

Deanna Porter

St Jude Medical 177 East County Road B St. Paul, MN 55117
dporter@sjm.com

Mark E Smith

American Preclinical Services 8945 Evergreen Blvd, NW Coon Rapids, MN 55433
msmith@apsemail.com

1Corresponding author.

ASME doi:10.1115/1.4035724 History: Received July 20, 2016; Revised January 05, 2017

Abstract

ISO 10993-4 in vivo thrombogenicity testing is required for regulatory approval of all blood-contacting medical devices and is often a key part of submission packages. Given the current state of in vivo thrombogenicity assays, the industry needs a more robust and reproducible assay design including in vitro models. This study describes an in vitro assay which integrates freshly-harvested ovine blood containing minimal heparin in a closed pumped loop. To confirm the reproducibility of this assay, control materials were identified which elicited either a positive or a negative thrombogenic response. These controls were used over a 13 month period, successfully demonstrating reproducibility in the resulting thrombogenicity scores, and were then used in a head-to-head comparison with an in vivo thrombogenicity study using a marketed, approved catheter as test article. Thrombogenicity scoring with the positive and negative controls was consistent over the 24 independent assays with >95% confidence (p = 1.0 for negative controls and p = 0.55 for positive controls) when in vitro results were compared to the in vivo assay. This in vitro blood loop method allows prediction of a materials' in vivo thrombogenicity, can substantially de-risk the materials or coating selection process and should replace the in vivo models currently in use.

Copyright (c) 2017 by ASME
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