A Preclinical Study of the Safety and Efficacy of Occlusin Trade-Mark-Sign 500 Artificial Embolization Device in Sheep

Journal Article · Fri Jun 15 00:00:00 EDT 2012 · Cardiovascular and Interventional Radiology

DOI:https://doi.org/10.1007/S00270-011-0218-7· OSTI ID:21608526

Nation, Patrick N ^[1]; Polakowski, Robert ^[2]; Biliske, Jennifer A ^[3]; Tiege, Paul B ^[4]; Griffith, Irwin J ^[5]

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1. University of Alberta, Laboratory Medicine and Pathology, Walter C. Mackenzie Health Sciences Centre (Canada)
2. BioLipids Inc (Canada)
3. University of Alberta, Biological Sciences, CW405, Biological Sciences Building (Canada)
4. University of Alberta, Lipid Products Research Alberta (LiPRA), 410 Agriculture/Forestry Centre (Canada)
5. IMBiotechnologies Ltd (Canada)

Introduction: This study evaluated the safety, effectiveness, and biodegradation of a new embolic agent, Occlusin Trade-Mark-Sign 503 Artificial Embolization Device (OCL 503). The agent consists of biodegradable poly-lactic-co-glycolic acid microspheres (150-212 {mu}m) coated with type I bovine collagen and was compared with Embosphere{sup Registered-Sign} Microspheres (300-500 {mu}m) in this controlled study of uterine artery embolization (UAE) in sheep. Methods: Unilateral UAE was performed in 32 adult ewes randomly assigned. Vessels were embolized to effective stasis. The cohort was divided into four groups, which were sacrificed at 1, 3, 6, and 12 months. Results: Both agents were 100% effective in achieving stasis. At 6 months, all OCL 503-treated arteries were occluded, the microspheres degraded with time, and at 12 months all four animals examined demonstrated recanalization. OCL 503 was found in the untreated uterine artery in one animal with no other evidence of non target embolization. In the Embosphere-treated group, all vessels remained occluded and microspheres were detected in the contralateral uterine artery in 6 of 15 examined vessels and in 10 vaginal, 2 ovarian, and 1 vesical artery. No procedural-related complications were seen in either group. Conclusions: OCL 503 is as effective an embolic agent as Embosphere{sup Registered-Sign} Microspheres when embolizing ovine uterine arteries and resorbs with time, allowing recanalization of the treated arteries. No device-related issues or adverse events were observed.

• OSTI ID: 21608526
• Journal Information: Cardiovascular and Interventional Radiology, Vol. 35, Issue 3; Other Information: DOI: 10.1007/s00270-011-0218-7; Copyright (c) 2012 Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
• Country of Publication: United States
• Language: English

Related Subjects

60 APPLIED LIFE SCIENCES
62 RADIOLOGY AND NUCLEAR MEDICINE
ADULTS
ARTERIES
BIODEGRADATION
CATTLE
GLYCOLIC ACID
MICROSPHERES
SAFETY
SHEEP
AGE GROUPS
ANIMALS
BLOOD VESSELS
BODY
CARBOXYLIC ACIDS
CARDIOVASCULAR SYSTEM
CHEMICAL REACTIONS
DECOMPOSITION
DOMESTIC ANIMALS
HYDROXY ACIDS
MAMMALS
MONOCARBOXYLIC ACIDS
ORGANIC ACIDS
ORGANIC COMPOUNDS
ORGANS
RUMINANTS
VERTEBRATES