The only spherical embolic agentcomprised of PVA hydrogel cross-linked with acrylic polymer

Bio

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bolization™

Optimal visualizationfor enhancedhandling and safety.

Precise sizecalibration fortargetedembolization.

Shape recovery for reliable delivery.

Elastic shaperecovery

Bead Block®

Catheter

Size (µm)

Freq

uenc

y %

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 (m

inutes)

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

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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:• In Europe, Bead Block is intended to be used for the embolisation of hypervascular tumours, including uterine fibroids and arteriovenous malformations (AVMs)• In the USA, Bead Block is not cleared by the FDA for uterine fibroid embolisation and is intended to be used for the embolisation of hypervascular tumours and arteriovenous malformations (AVMs) only

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.

UFE-Specific Potential Complications:Potential post-procedure complications include: 1. Abdominal pain2. Discomfort3. Fever4. Nausea5. Constipation6. Premature ovarian failure (ie menopause)7. Amenorrhea8. Infection of the pelvic region9. Uterine/ovarian necrosis10. Phlebitis11. Deep vein thrombosis with or without pulmonary embolism12. Vaginal discharge13. Tissue passage, fibroid sloughing, or fibroid expulsion post UFE14. Post-UFE intervention to remove necrotic fibroid tissue15. Vagal reaction16. Transient hypertensive episode17. Hysterectomy

Bead Block is manufactured by Biocompatibles UK Ltd, Chapman House, Farnham BusinessPark, Weydon Lane, Farnham, Surrey, GU9 8QL, UK. Biocompatibles UK Ltd is a BTGInternational group company. 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 a registered 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 Optitorque and PROGREAT are trademarks of TerumoCorporation. Renegade and Contour SE are trademarks of Boston Scientific Corporation.Rebar is a registered trademark and Echelon and Nautica are trademarks of ev3 inc. Vasco isa trademark of Balt Extrusion. Omnipaque and Visipaque are trademarks of GE HealthcareInc. Isovue is a registered trademark of Bracco Diagnostics, Inc. Optiray is registeredtrademark of Mallinkrodt Inc. © Copyright 2012 Biocompatibles UK Ltd. IVMPRC12-018 Rev 1.

Phone: +44 (0)1252 732 732Fax: +44 (0)1252 732 777E: marketing@biocompatibles.comwww.biocompatibles.com

Bead Block® ordering information

For more information, please contact:

Biocompatibles UK LimitedChapman HouseFarnham Business ParkWeydon Lane, FarnhamSurrey, GU9 8QL, UK

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

Biocompatibles UK Ltd is a

BTG International group company

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com

pa

tibl

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bolization™