About this Abstract |
| Meeting |
MS&T24: Materials Science & Technology
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| Symposium
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Society for Biomaterials: Biomaterial Applications in Today’s Industry: Development, Translation & Commercialization
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| Presentation Title |
Transarterial Radioembolization with Eye90 Microspheres®: Biological Evaluation of Novel Microsphere Container-Closure and Delivery Device Intended for Investigational Clinical Study in Patients with Hepatocellular Carcinoma |
| Author(s) |
Kathleen O'Connell, Yasmin Omar, Declan Hussey, Ivan Toponarksi, Brandi Woods, Catherine A. Whitman, Sharon Kehoe |
| On-Site Speaker (Planned) |
Sharon Kehoe |
| Abstract Scope |
Hepatocellular carcinoma (HCC) is a common cause of cancer deaths worldwide. Transarterial radioembolization (TARE) with Eye90 microspheres® (ABK Biomedical) are being evaluated in an investigational clinical study for effectiveness and safety in patients with HCC. A novel (polymer-based) microsphere container-closure and delivery device have been designed to: (i) withstand exposure to beta irradiation from the microspheres when used as intended and (ii) create a sterile fluidpath with commercial microcatheters to facilitate microsphere delivery to the target site(s). Here, we report biological outcomes for the continuous fluidpath of the microsphere container-closure and delivery device, evaluated as a single test article in accordance with ISO 10993 for cytotoxicity, sensitization, irritation, pyrogenicity (material mediated), acute systemic toxicity, and hemocompatibility, under good laboratory practices.
The safety of the devices, categorized as external communicating devices with limited indirect contact to blood, have been established to permit their utilization in the investigational clinical study.
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