Bead Block embosphere EC10-141 A4 ROW web.pdf - Biocompatibles

Bead Block vs Embosphere ®Comparative analysisRandomised Trial to Compare Embolic Agents for Uterine Artery Embolisation 1Robert Worthington-Kirsch, Gary Siskin, Paul Hegener, Richard ChesnickTrial Design• Best protocol for each embolic- Bead Block – start with 700-900µm- Embosphere ® – start with 500-700µm (unless ovarian artery seen)• Upsize if necessary in both arms• Trial meets good evidence criteriafor medical device assessment 2Leiomyoma PerfusionProportional Changein Leiomyoma VolumeOverall Quality of Life ScoreEmbosphere Bead Block Embosphere Bead Block Embosphere Bead Block10100910090880780706560605043404030220201100Pre-UAE1 WeekPost UAE3 MonthsPost UAE6 MonthsPost UAE0Pre-UAE1 WeekPost UAE3 MonthsPost UAE6 MonthsPost UAE0Pre-UAE3 MonthsPost UAE6 MonthsPost UAE12 MonthsPost UAEThis trial demonstrates:• Bead Block and Embosphere perform in the same way with regards to the rate of fibroiddevascularisations, volume reduction and quality of life• Size selection based on compressibility, elasticity and depth of penetration of the embolicagents is of particular importanceElastic Shape Recovery 380100Deformation (%)604020Elastic Recovery (%) 3,490807060003 Bead Block Embosphere ®2 4 6 8 10 12Force (g)CompressibilityGraphs adapted from: Seron et al. CIRSE presentation, Nice, France, September 2005.50Bead Block Embosphere ®0 100 200 300 400Time (msecs)Bead Block is compressible and can be temporarilydeformed to facilitate smooth passage through thecatheter lumen into the vasculature. 3Bead Block rapidly returns to its spherical shape oncedelivered from the catheter, facilitating travel to thetarget vessel and effective occlusion at the end point. 3

Bead Block Embosphere ®Tinted Beads forImproved VisibilityYesNoColour-coded Syringes Yes NoStructure 4 Microporous MicroporousRigidity (KpA) *4 24.0 27.5Elasticity 3 Equivalent EquivalentHydrophilic Yes YesTime to Suspension 4