IVMPRC12-018 New Bead Block Brochure.pdf - Biocompatibles

The only spherical embolic agentcomprised of PVA hydrogelcross-linked with acrylic polymerBiocompatibles Excellencein Embolization

The only spherical embolic agent comprised of PVA hydrogel cross-linked with acrylic polymer1 Compressible3 Precise calibration✓• Reliable delivery incatheter and vessels.• Precise distalembolization.• More resistantto clogging. 1• No fragmentation. 2Bead Block ®CatheterCompressible✓Precise sizecalibration fortargetedembolization.Frequency %181614121086420100-300µm 700-900µm300-500µm 900-1200µm500-700µm0 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300Size (µm)2Suspension and delivery4Elastic✓When using 5ml ofIsovue ® -300 contrast,Bead Block ® stays insuspension morethan twice as longas Embosphere ® andContour SE . 1This may allow forless clogging and amore uniformdistribution anddelivery of beads.Time (minutes)6.005.004.003.002.001.002ml Beads + 3ml Saline + 5ml Isovue ® -300 Contrast✓5✓Shape recovery forreliable delivery.Blue tintOptimal visualizationfor enhancedhandling and safety.Bead Block ®CatheterElastic shaperecovery0.00Bead Block Contour SE EmbosphereEmbolic Agent

The only spherical embolic agent comprised of PVA hydrogel cross-linked with acrylic polymerHow does Bead Block ® compare?What does this mean?2Bead Block ®PVA hydrogel cross-linked with acrylic polymerEmbosphere ®Acrylic polymer structure (Trisacryl ® )Contour SE Macroporous PVA 1Embozene Polyphosphazene-coated polymethylmethacrylateRigidity and fragmentation• Bead Block ® is significantly less rigid than Embosphere ® . 3• An in-vivo animal study by Bilbao et al, 2 published in JVIR in 2008, demonstratedthat:– Bead Block remained round or slightly oval and showed no fragmentationat 48 hours after embolization. 2– Embosphere had a large number of particles that showed a fragmentedappearance at 48 hours after embolization. 2• Trisacryl ® gelatin microspheres (Embosphere) have a high rigidity and deformslightly under a sustained compression since they have a high elasticity. 4• Polyphosphazene-coated polymethylmethacrylate microspheres (Embozene )are soft and deform considerably under sustained compression and are more viscousthan Bead Block and Embosphere. 4

The only spherical embolic agent comprised of PVA hydrogel cross-linked with acrylic polymerSuspension and deliveryComplete vascular occlusion• When using 5ml of Isovue ® -300 contrast,Bead Block ® stays in suspension morethan twice as long as Embosphere ®and Contour SE . 1• This may allow for less cloggingand a more uniform distributionand delivery of beads.• In the Bilbao study, Bead Block ® tended to locate in vessels of small size (eg arciformarteries) and appeared individualized or formed rows. 2• Most Bead Block specimens adapted perfectly to the vascular wall, completelyoccluding the vessel lumen. 2• Embosphere ® particles do not adapt to the walls of the arteries. 2• The degree of adaptability of Contour SE particles to the vascular wall is highly variable. 2Endothelial inflammation• Inflammatory and giant cell reactions after embolization procedures depend on theembolic material. 7Aggregation• Bilbao et al reported that Embosphere particles showed a tendency to cluster in groupswithin the arteries. 2• Embosphere particles showed a greater tendency to aggregate. 2• This tendency of Embosphere particles to aggregate within the arteries has beenreported by other authors. 2• Nonspherical PVA particles tend to aggregate in the hub of the micro-catheter, makingirrigation with saline necessary to be able to use the micro-catheter. 5,6• Nonspherical PVA particles have a tendency to clump as a result of particleaggregation, leading to proximal occlusion of the targeted blood vessels. 6• The overall inflammatory reaction was low for spherical embolic agents. However, markedinflammation was associated with small Embosphere particles at 4 weeks, a finding thatmight be caused by the allogeneic overcoat. 7Recanalization• For many years polyvinyl alcohol (PVA) particles have been the most frequently usedparticle embolic agent. However, the irregular shape and variable granulometric sizes ofthese particles prevent correlation of the arterial occlusion level and the particle size.These properties may cause proximal large vessel occlusion and recanalization in thelate period. This created the need for the search to find alternative embolizing agentswith more targeted and distal occlusion. 5• The highest extent of recanalization was observed with Contour SE particles at 4 weeks.This might be caused by its non-elastic deformation within the vessels, which renders theparticles more susceptible to redistribution phenomena. 8

The only spherical embolic agent comprised of PVA hydrogel cross-linked with acrylic polymerSuspension and deliveryBead Block ® preparationBead Block ® contrast media and supension• When using 5ml of Isovue ® -300 contrast,Bead Block ® stays in suspension morethan twice as long as Embosphere ®and Contour SE . 1• This may allow for less cloggingand a more uniform distributionand delivery of beads.12345Draw up contrast medium directly into the Bead Block ® pre-filledsyringe. To obtain an even suspension, initially use 50:50 contrastto Bead Block volume. If Bead Block sinks, add more contrast.If Bead Block floats, add more saline.Remove all air from the syringe.Gently invert the 20ml syringe several times to evenly suspendthe Bead Block/contrast solution. Do not use a shaking motion.Wait to allow Bead Block to suspend properly.Attach the 20ml syringe to the side port of the luer-lock 3-waystopcock. Attach the injection syringe (1-5ml according to preference)to the second port. Attach the remaining port of the stopcock to thedelivery catheter.Color Code100to300300to500500to700700to900900to1200Size Range µm5.0 ml 5.0 ml 5.0 ml 5.0 ml1 min 1 min 1 min 1 min5.0 ml 5.0 ml 5.0 ml 5.0 ml2 mins 1 min 1 min 2 mins5.0 ml 5.0 ml 5.0 ml 4.0 ml3 mins 2 mins 2 mins 5 mins5.0 ml 5.0 ml 5.0 ml 2.0 ml5 mins 4 mins 4 mins 5 mins2.0 ml 2.0 ml 2.0 ml 2.0 ml3 mins 3 mins 4 mins 6 minsKey:Omnipaque 300Isovue ® -300Optiray ® 300Initial volume of contrast medium to add to achieve suspension for atleast 45 secondsApproximate time to achieve suspension, inverting several times every20 secondsVisipaque 320100to300300to500500to700700to900900to1200Size Range µmColor CodeAggregation• Bilbao et al reported that Embosphere particles showed a tendency to cluster in groupswithin the arteries. 2• Embosphere particles showed a greater tendency to aggregate. 2Ensure all air is purged from the system prior to injection.Do not pass the content vigorously between syringes when obtaining suspension/re-suspension. Exercise conservative judgment in determining the embolization endpoint.Bead Block administrationBead Block catheter compatibility for easy delivery100to300Inner Diameter (ID) >0.040” >1020µm 0.026”-0.040” 650-1020µm 0.0205”-0.026” 520-650µm 0.015”-0.0205” 380-520µmGlidecath 4Fr✓Glidecath 5Fr✓Optitorque 4Fr✓Optitorque 5Fr✓Vasco +35 (3.8Fr)✓PROGREAT 2.7Fr✓PROGREAT 2.8Fr✓Renegade High Flow 2.8✓Vasco +25 (3Fr)✓Vasco +28 (3.3Fr)✓Rebar 027 (2.8Fr)✓PROGREAT (2.4Fr)✓Renegade✓Vasco +18. (2.1Fr)✓Vasco +21 (2.4Fr)✓Rebar 18 (2.3Fr)✓Echelon 10 (1.7Fr)✓Echelon 14 (1.9Fr)✓Nautica 14 XL (2.2Fr)✓Rebar 10 (1.7Fr)✓Rebar 14 (1.9Fr)100to300Size Range µmColor Code• This tendency of Embosphere particles to aggregate within the arteries has beenreported by other authors. 2• Nonspherical PVA particles tend to aggregate in the hub of the micro-catheter, makingirrigation with saline necessary to be able to use the micro-catheter. 5,6• Nonspherical PVA particles have a tendency to clump as a result of particleaggregation, leading to proximal occlusion of the targeted blood vessels. 6123Inject the Bead Block/contrast solution from the injection syringe under fluoroscopicvisualization using a slow pulsatile action, while observing the contrast flow rate.If there is no effect on the flow rate, repeat the delivery process with additional injections ofBead Block/contrast solution or larger sized Bead Block may be considered.If the Bead Block/contrast solution requires re-suspension, gently invert the 20mlsyringe several times.300to500500to700700to900900to1200✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓✓ ✓ ✓✓✓ ✓✓ ✓Bead Block is compatible with all 4F and 5F catheters (minimum ID of 0.040”/1040µm)Bead Block is compatible with all 4F and 5F catheters (minimum ID of 0.040”/1040µm)✓✓✓✓✓✓✓300to500500to700700to900900to1200

Bead Block® ordering informationLabel Color andNominal Bead Size100-300µm300-500µm500-700µm700-900µm900-1200µm2ml Bead Block is suspended in physiological bufferedsaline in 20ml syringe and is packed singly.For more information or to order, please contact:Customer ServiceBiocompatibles, Inc.115 Hurley RoadBuilding 3Oxford CT 06478USAVolume of Beads2ml2ml2ml2ml2mlProduct CodeEB2S103EB2S305EB2S507EB2S709EB2S912Toll Free Phone: 877.626.9989Toll Free Fax: 877.626.9910Phone: 203.262.4198Fax: 203.262.6314E: orders@biocompatibles.comwww.biocompatibles.comReferences1. Lewis A et al. In Vitro Evaluation of Microspherical Embolization Agents.J Mater Sci: Mater Med 17 (2006) 1193-204.2. Bilbao, JI et al. Comparative Study of Four Different Spherical Embolic Particles in an AnimalModel: A Morphologic and Histologic Evaluation. J Vasc Intervent Radiol 19 (2008) 1625-1638.3. Hidaka K et al. Compression and relaxation tests are complementary to evaluate embolisationmicrospheres. Comparison of Embosphere, Embozene and Bead Block.CIRSE presentation, Valencia, Spain, October 2010.4. Hidaka K et al. Elasticity and viscoelasticity of embolization microspheres.J Mech Behav Biomed Mater 4 (2011) 2161-7.5. Senturk C et al. Looking for the Ideal Particle: An Experimental Embolization Study.Cardiovasc Intervent Radiol 33 (2010) 336-345.6. Hong K et al. Effects of the Type of Embolization Particles on Carboplatin Concentration in LiverTumors after Transcatheter Arterial Chemoembolization in a Rabbit Model of Liver Cancer.J Vasc Interv Radiol 16 (2005) 1711–1717.7. Stampfl U et al. Experimental Liver Embolization with Four Different Spherical Embolic Materials:Impact on Inflammatory Tissue and Foreign Body Reaction.Cardiovasc Intervent Radiol 32 (2009) 303-312.8. Stampfl S et al. Inflammation and Recanalization of Four Different Spherical EmbolizationAgents in the Porcine Kidney Model. J Vasc Interv Radiol 19 (2008) 577-586.Important informationIndications:Bead Block is intended to be used for the embolization of hypervascular tumors and arteriovenousmalformations (AVMs).Potential Complications:1. Undesirable reflux or passage of Bead Block into normal arteries adjacent to the targetedlesion or through the lesion into other arteries or arterial beds, such as the internal carotidartery, pulmonary, or coronary circulations.2. Pulmonary embolization.3. Ischemia at an undesirable location.4. Capillary bed saturation and tissue damage.5. Ischemic stroke or ischemic infarction.6. Vessel or lesion rupture and hemorrhage.7. Neurological deficits including cranial nerve palsies.8. Vasospasm.9. Death.10. Recanalization.11. Foreign body reactions necessitating medical intervention.12. Infection necessitating medical intervention.13. Clot formation at the tip of the catheter and subsequent dislodgement.Caution:Federal (USA) law restricts the sale of this device by or on order of a physician.Reimbursement Service:The Pinnacle Health GroupPhone: 866-369-9290 or 215-369-9290Fax: 877-499-2986 or 215-369-9198E: LCBead@thepinnaclehealthgroup.comBeadBlock@thepinnaclehealthgroup.comBead Block is manufactured by Biocompatibles UK Ltd, Chapman House, Farnham Business Park,Weydon Lane, Farnham, Surrey, GU9 8QL, UK. Biocompatibles, Inc. and Biocompatibles UK Ltd areBTG International group companies. BTG and the BTG roundel logo are registered trademarks ofBTG International Ltd. Bead Block is a registered trademark of Biocompatibles UK Ltd. Embosphere is aregistered trademark of BioSphere Medical, Inc. Embozene is a trademark of CeloNova BioSciences, Inc.Trisacryl is a registered trademark of Pall Corporation. Glidecath is a registered trademark and Optitorqueand PROGREAT are trademarks of Terumo Corporation. Renegade and Contour SE are trademarks ofBoston Scientific Corporation. Rebar is a registered trademark and Echelon and Nautica are trademarksof ev3 inc. Vasco is a trademark of Balt Extrusion. Omnipaque and Visipaque are trademarks ofGE Healthcare Inc. Isovue is a registered trademark of Bracco Diagnostics, Inc. Optiray is registeredtrademark of Mallinkrodt Inc. © Copyright 2012 Biocompatibles UK Ltd. IVMPRC12-018 Rev 1.Biocompatibles Excellencein EmbolizationBiocompatibles, Inc. is aBTG International group company