the only spherical embolic agent comprised of pva hydrogel cross
TRANSCRIPT
The only spherical embolic agentcomprised of PVA hydrogel cross-linked with acrylic polymer
Bio
com
pa
tibl
es Excell
ence in Em
bolization™
Optimal visualizationfor enhancedhandling and safety.
Precise sizecalibration fortargetedembolization.
Shape recovery for reliable delivery.
Elastic shaperecovery
Bead Block®
Catheter
Size (µm)
Frequency %
0 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300
18
16
14
12
10
8
6
4
2
0
100-300µm300-500µm 900-1200µm 500-700µm
700-900µm
Precise calibration3
Elastic4
Blue tint5
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The only spherical embolic agent comprised of PVA hydrogel cross-linked with acrylic polymer
When using 5ml ofIsovue®-300 contrast,Bead Block® stays insuspension morethan twice as longas Embosphere® andContour SE™.1
This may allow forless clogging and amore uniformdistribution anddelivery of beads.
• Reliable delivery in catheter and vessels.• Precise distal embolization.• More resistant to clogging.1
• No fragmentation.2�
2ml Beads + 3ml Saline + 5ml Isovue®-300 Contrast
Time (minutes)
Bead Block Contour SE Embosphere Embolic Agent
6.00
5.00
4.00
3.00
2.00
1.00
0.00
Compressible1
Suspension and delivery2
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Compressible
Bead Block®
Catheter
• Bead Block® is significantly less rigid than Embosphere®.3
• An in-vivo animal study by Bilbao et al,2 published in JVIR in 2008, demonstrated that:
– Bead Block remained round or slightly oval and showed no fragmentation at 48 hours after embolization.2
– Embosphere had a large number of particles that showed a fragmented appearance at 48 hours after embolization.2
• Trisacryl® gelatin microspheres (Embosphere) have a high rigidity and deform slightly 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 viscous than Bead Block and Embosphere.4
Rigidity and fragmentation
What does this mean?
Bead Block®
2 Embosphere®
Contour SE™
Embozene™
PVA hydrogel cross-linked with acrylic polymer
Acrylic polymer structure (Trisacryl®)
Macroporous PVA1
Polyphosphazene-coated polymethylmethacrylate
How does Bead Block®compare?
The only spherical embolic agent comprised of PVA hydrogel cross-linked with acrylic polymer
• Inflammatory and giant cell reactions after embolization procedures depend on the embolic material.7
• The overall inflammatory reaction was low for spherical embolic agents. However, marked inflammation was associated with small Embosphere particles at 4 weeks, a finding that might be caused by the allogeneic overcoat.7
Endothelial inflammation
• For many years polyvinyl alcohol (PVA) particles have been the most frequently used particle embolic agent. However, the irregular shape and variable granulometric sizes of these particles prevent correlation of the arterial occlusion level and the particle size. These properties may cause proximal large vessel occlusion and recanalization in the late period. This created the need for the search to find alternative embolizing agents with 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 the particles more susceptible to redistribution phenomena.8
Recanalization
Complete vascular occlusion
• In the Bilbao study, Bead Block® tended to locate in vessels of small size (eg arciform arteries) and appeared individualized or formed rows.2
• Most Bead Block specimens adapted perfectly to the vascular wall, completely occluding 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.2
rised of PVA hydrogel cross-linked with acrylic polymerThe only spherical embolic agent comprised of PVA hydrogel cross-linked with acrylic polymer
• Bilbao et al reported that Embosphere particles showed a tendency to cluster in groups within the arteries.2
• Embosphere particles showed a greater tendency to aggregate.2
• This tendency of Embosphere particles to aggregate within the arteries has been reported by other authors.2
• Nonspherical PVA particles tend to aggregate in the hub of the micro-catheter, making irrigation 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 particle aggregation, leading to proximal occlusion of the targeted blood vessels.6
Aggregation
Suspension and delivery
• When using 5ml of Isovue®-300 contrast, Bead Block® stays in suspension more than twice as long as Embosphere®
and Contour SE™.1
• This may allow for less clogging and a more uniform distribution and delivery of beads.
Bead Block® preparation
1
2
3
4
5
1
2
3
Bead Block administration
Inject 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 20ml syringe several times.
Do not pass the content vigorously between syringes when obtaining suspension/re-suspension. Exercise conservative judgment in determining the embolization endpoint.
Draw up contrast medium directly into the Bead Block® pre-filledsyringe. To obtain an even suspension, initially use 50:50 contrast to 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 suspend the 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.
Ensure all air is purged from the system prior to injection.
Bead Block® contrast media and suspension
Bead Block catheter compatibility for easy delivery
Bead Block is compatible with all 4F and 5F catheters (minimum ID of 0.040”/1040µm)
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Glidecath 4Fr
Glidecath 5Fr
Bead Block is compatible with all 4F and 5F catheters (minimum ID of 0.040”/1040µm)
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Optitorque 5Fr
Optitorque 4Fr
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Vasco +35 (3.8Fr)
Renegade High Flow 2.8
Vasco +28 (3.3Fr)
Vasco +25 (3Fr)
Rebar 027 (2.8Fr)
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Renegade
Vasco +18. (2.1Fr)
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Vasco +21 (2.4Fr)
Rebar 18 (2.3Fr)
Echelon 10 (1.7Fr)
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Echelon 14 (1.9Fr)
Nautica 14 XL (2.2Fr)
Rebar 10 (1.7Fr)
Rebar 14 (1.9Fr)
PROGREAT 2.7Fr
PROGREAT 2.8Fr
PROGREAT (2.4Fr)
Size Range µm
Color Code
100to 300
300to 500
500to 700
700to 900
900to
1200
100to 300
300to 500
500to 700
700to 900
900to
1200
100to 300
5.0 ml 5.0 ml 5.0 ml 5.0 ml
1 min 1 min 1 min 1 min
5.0 ml 5.0 ml 5.0 ml 5.0 ml
2 mins 1 min 1 min 2 mins
5.0 ml 5.0 ml 5.0 ml 4.0 ml
3 mins 2 mins 2 mins 5 mins
5.0 ml 5.0 ml 5.0 ml 2.0 ml
5 mins 4 mins 4 mins 5 mins
2.0 ml 2.0 ml 2.0 ml 2.0 ml
3 mins 3 mins 4 mins 6 mins
300to 500
500to 700
700to 900
900to
1200
Omnipaque™ 300
Isovue® -300
Optiray®300
Visipaque™320
Initial volume of contrast medium to add to achieve suspension for atleast 45 seconds
Approximate time to achieve suspension, inverting several times every20 seconds
Key:
900to
1200
700to 900
500to 700
300to 500
100to 300
Size Range µm
Color Code
Size Range µm
Color Code
Inner Diameter (ID) >0.040” >1020µm 0.026”-0.040” 650-1020µm 0.0205”-0.026” 520-650µm 0.015”-0.0205” 380-520µm
rised of PVA hydrogel cross-linked with acrylic polymerThe only spherical embolic agent comprised of PVA hydrogel cross-linked with acrylic polymer
References1. 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 Animal Model: 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 embolisation microspheres. 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 Liver Tumors 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 Embolization Agents 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 targeted
lesion 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.
Bead 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 are BTG International group companies. BTG and the BTG roundel logo are registered trademarks of BTG 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 of Boston 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 of GE 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.
Toll Free Phone: 877.626.9989Toll Free Fax: 877.626.9910Phone: 203.262.4198Fax: 203.262.6314E: [email protected]
Bead Block® ordering information
For more information or to order, please contact:
Customer ServiceBiocompatibles, Inc.115 Hurley RoadBuilding 3Oxford CT 06478USA
2ml Bead Block is suspended in physiological buffered saline in 20ml syringe and is packed singly.
2ml
2ml
2ml
2ml
2ml
EB2S103
EB2S305
EB2S507
EB2S709
EB2S912
Label Color and Nominal Bead Size Volume of Beads Product Code
100-300µm
300-500µm
500-700µm
700-900µm
900-1200µm
Reimbursement Service: The Pinnacle Health Group Phone: 866-369-9290 or 215-369-9290Fax: 877-499-2986 or 215-369-9198E: [email protected]
Biocompatibles, Inc. is a
BTG International group company
Bio
com
pa
tibl
es Excell
ence in Em
bolization™