| About this Abstract |
| Meeting |
MS&T22: Materials Science & Technology
|
| Symposium
|
Society for Biomaterials: Biomaterial Applications in Today’s Industry: Development, Translation & Commercialization
|
| Presentation Title |
Long-Term Biocompatibility of a Novel Radiopaque Non-compressible Microsphere for Transarterial Embolization |
| Author(s) |
Kathleen O'Connell, Daniel Boyd, Robert J. Abraham, Sharon Kehoe |
| On-Site Speaker (Planned) |
Kathleen O'Connell |
| Abstract Scope |
Easi-Vue embolic (EV) microspheres are glass-based radiopaque, non-compressible, and non-resorbable microspheres intended for the treatment of arteriovenous malformations and hypervascular tumors. The radiopacity is designed to enable clinicians to directly monitor microsphere deposition, allowing for direct intra-procedural confirmation of implantation.
To establish long-term safety and biocompatibility, EV microspheres manufactured by ABK Biomedical were subjected to testing in accordance with ISO 10993. Toxicological risk, which addresses numerous biological endpoints (e.g., genotoxicity), was determined using exhaustive extractable and leachable protocols alongside various analytical techniques to identify and quantify migrated chemical compounds (inorganic and organic). Hemocompatibility, cytotoxicity, sensitization/irritation, and systemic toxicity were established under good laboratory practices (GLP). GLP animal studies (rabbit intramuscular implantation and swine renal artery embolization) confirmed no clinically significant pathological or systemic abnormalities and effective arterial occlusion at 4 and 13-weeks.
The biological endpoints required for a long-term implantable device has been satisfied based on ISO 10993 requirements. |