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Updated: Jul 1, 2026

Autologous Endothelial Progenitor Cell-Seeding Technology and Biocompatibility Testing For Cardiovascular Devices in Large Animal Model

Autologous Endothelial Progenitor Cell-Seeding Technology and Biocompatibility Testing For Cardiovascular Devices in Large Animal Model

Published on: September 9, 2011

Testing percutaneous arterial closure devices: an animal model.

Rui-Fang Ni¹, Pawanrat Kranokpiraksa, Dusan Pavcnik

¹Dotter Interventional Institute, Oregon Health Sciences University, Portland, OR 97201, USA.

Cardiovascular and Interventional Radiology

|September 10, 2008

Summary

New percutaneous arterial closure devices (PACDs) were tested in sheep. These devices, including chitostan-based topical agents and a submucosa plug, showed promise in controlling bleeding after arterial procedures.

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Area of Science:

Biomedical engineering
Vascular surgery
Medical device development

Background:

Percutaneous arterial closure devices (PACDs) are crucial for minimizing complications after minimally invasive vascular procedures.
Early-stage development of novel PACDs requires robust pre-clinical testing models to assess efficacy and guide improvements.

Purpose of the Study:

To evaluate the efficacy of novel percutaneous arterial closure devices (PACDs) during their developmental phase.
To assess the hemostatic performance of chitostan-based topical devices and a porcine small intestinal submucosa plug in a large animal model.

Main Methods:

Utilized the ovine superficial femoral artery as a pre-clinical model for testing PACD efficacy.
Evaluated two topical devices (chitostan-based) and one staple-mediated device, alongside a submucosa plug, in 37 sheep.

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Assessed device performance through follow-up angiography, monitoring for bleeding and time to hemostasis.

Main Results:

The study successfully evaluated the efficacy of developmental PACDs in a relevant anatomical location.
Hemostatic performance was quantified by the absence/presence of bleeding and the time required for cessation.
The data gathered informed modifications to the PACDs, leading to enhanced device performance.

Conclusions:

The ovine superficial femoral artery model is effective for testing and refining percutaneous arterial closure devices.
The tested PACDs, including chitostan-based and submucosa plug devices, demonstrated potential for effective arterial sealing.
Iterative testing and modification based on pre-clinical results are vital for improving PACD efficacy and patient safety.