title: A preclinical study of the safety and efficacy of Occlusin™ 500 Artificial Embolization Device in sheep.
abstract: BACKGROUND
  This study evaluated the safety, effectiveness, and biodegradation of a new embolic agent, Occlusin™ 503 Artificial Embolization Device (OCL 503). The agent consists of biodegradable poly-lactic-co-glycolic acid microspheres (150-212 μm) coated with type I bovine collagen and was compared with Embosphere® Microspheres (300-500 μm) 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® 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.
authors: Radiology and Diagnostic Imaging, Walter C. Mackenzie Health Sciences Centre, University of Alberta, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada. drrichardowen@tbwifi.ca
authors: Richard J
authors: RJ
authors: Owen
authors: Patrick N
authors: PN
authors: Nation
authors: Robert
authors: R
authors: Polakowski
authors: Jennifer A
authors: JA
authors: Biliske
authors: Paul B
authors: PB
authors: Tiege
authors: Irwin J
authors: IJ
authors: Griffith
mesh_terms: D000180:Acrylic Resins; D000818:Animals; D002417:Cattle; D020099:Coated Materials, Biocompatible; D003094:Collagen / Q000008:administration & dosage / Q000494:pharmacology; D024042:Collagen Type I / Q000494:pharmacology; D003287:Contrast Media / Q000008:administration & dosage; D005260:Female; D005471:Fluoroscopy; D005780:Gelatin; D006016:Glycolates / Q000008:administration & dosage / Q000494:pharmacology*; D007472:Iohexol / Q000008:administration & dosage; D019344:Lactic Acid / Q000008:administration & dosage / Q000494:pharmacology*; D008863:Microspheres; D011091:Polyesters; D011100:Polyglycolic Acid / Q000494:pharmacology; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011108:Polymers / Q000008:administration & dosage / Q000494:pharmacology*; D011897:Random Allocation; D012756:Sheep; D055357:Uterine Artery Embolization / Q000295:instrumentation*
chemical_list: D000180:Acrylic Resins; D020099:Coated Materials, Biocompatible; D024042:Collagen Type I; D003287:Contrast Media; D006016:Glycolates; D011091:Polyesters; D011108:Polymers; C496735:trisacryl gelatin microspheres; C031149:glycolic acid; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D007472:Iohexol; C033616:poly(lactide); D005780:Gelatin; D003094:Collagen