2
Compressibility 3 Graph adapted from Hidaka CIRSE presentation, Valencia, October 2010. Bead Block (Microporous) Internal View 1 Embozene (Microporous) Internal View 2 Comparative analysis Bead Block rapidly returns to its spherical shape once delivered from the catheter, facilitating travel to the target vessel and effective occlusion at the end point. 6 Bead Block ® is compressible and can be temporarily deformed to facilitate smooth passage through the catheter lumen into the vasculature. 6 Bead Block: High In-vivo Elasticity 4 Embozene: High In-vivo Deformation 5 Final Location/Deformation (T2) Bead Block ® Embozene Initial Location (T0) T0 T0 T1 T1 T2 T2 Blood Pressure Resistance Bead Block has a consistent compressibility across the size range for predictable handling and catheter delivery. Compressibility Consistency 2 Bead Block ® vs Embozene B i o c o m p a t i b l e s E x c e l l e n c e i n E m b o l i z a t i o n Biocompatibles, Inc is a BTG International group company

Comparative analysis - btg-im.combead.btg-im.com/uploads/document_r/p175p59kkm5oa1q131b1nim81… · References: 1. Lewis A, Adams C, Busby W et al. Comparative In Vitro Evaluation

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Page 1: Comparative analysis - btg-im.combead.btg-im.com/uploads/document_r/p175p59kkm5oa1q131b1nim81… · References: 1. Lewis A, Adams C, Busby W et al. Comparative In Vitro Evaluation

Compressibility3

Graph adapted from Hidaka CIRSE presentation, Valencia, October 2010.

Bead Block(Microporous)Internal View1

Embozene(Microporous)Internal View2

Comparative analysis

Bead Block rapidly returns to its spherical

shape once delivered from the catheter,

facilitating travel to the target vessel and

effective occlusion at the end point.6

Bead Block® is compressible and can be

temporarily deformed to facilitate smooth passage

through the catheter lumen into the vasculature.6

Bead Block:High In-vivo Elasticity4

Embozene:High In-vivo Deformation5Final Location/Deformation (T2)

Bead Block®Embozene ™

Initial Location (T0)

T0

T0

T1

T1 T2

T2

Blood Pressure

Resistance

Bead Block has a consistent compressibility

across the size range for predictable handling

and catheter delivery.

Compressibility Consistency2

Bead Block®vs Embozene™

Bio

com

pa

tibl

esExcellence in Em

bolization™

Biocompatibles, Inc is a

BTG International group company

Page 2: Comparative analysis - btg-im.combead.btg-im.com/uploads/document_r/p175p59kkm5oa1q131b1nim81… · References: 1. Lewis A, Adams C, Busby W et al. Comparative In Vitro Evaluation

References:1. Lewis A, Adams C, Busby W et al. Comparative In Vitro Evaluation of

Microspherical Embolisation Agents. J Mater Sci: Mater Med 17 (2006) 1193-204.2. Data on file, Biocompatibles UK Ltd.3. Hidaka 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. Namur, J et al. Arterial location of 3 sizes of Embosphere and Bead Block in Sheep Uterus Model. CIRSE 2005 Abstract 47.7.5.

5. Verret et al. Deformation influences arterial distribution: Embozene vs Embosphere in sheep kidney and uterus. CIRSE presentation, Valencia, Spain, October 2010.

6. Seron et al. Rigidity and Elasticity of Embosphere, Bead Block and Contour SE Microspheres. CIRSE presentation, Nice, France, September 2008.

7. Laurent A, Velzenberger E, Pelage JP, Lewis A. Do Microspheres with Narrow orStandard Size Distributions Localize Differently in Vasculature? An Experimental Study in Sheep Kidney and Uterus. J Vasc Interv Radiol 19 (2008) 1733-9.

Bead Block is manufactured by Biocompatibles UK Ltd. Chapman House, Farnham Business Park, Weydon Lane, Farnham, Surrey, GU9 8QL, UK. Biocompatibles UK Ltd is a BTG International group company. BTG and the BTG roundel are registered trademarks of BTG International Ltd. Bead Block is a registered trademark of Biocompatibles UK Ltd. Embozene is a trademark of CeloNova BioSciences, Inc. Embosphere is a registered trademark of BioSphere Medical, Inc. © Copyright 2012 Biocompatibles UK Ltd. IVMPRC11-022 Rev 2.

Important InformationIndications:In the USA, Bead Block is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (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 carotid artery, 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.

81.5

1.3 17.1 13.3

78.3

8.3

Graph adapted from Laurent et al J Vasc Interv Radiol 19 (2008) 1733-9.

Bead Block (ND) 700-900µm

Bead Block (NSD) 900µm

As shown by Laurent et al7,

a microsphere with a

narrow size distribution

(NSD) is NOT more

efficient in terms of

targeted delivery than a

microsphere, such as

Bead Block,® which has a

normal distribution (ND) in

size range.7

Precisely Calibrated Size7

Bio

com

pa

tibl

esExcellence in Em

bolization™

Biocompatibles, Inc is a

BTG International group company

Bead Block®vs Embozene™

Toll Free Phone: 877.626.9989Toll Free Fax: 877.626.9910

Phone: 203.262.4198Fax: 203.262.6314

Email: [email protected]

www.biocompatiblesinc.com

Ordering Information

For more information or to order, please contact:

Customer ServiceBiocompatibles Inc115 Hurley Road, Bldg 3Oxford, CT 06478

2ml Bead Block is suspended in 5ml physiological buffered salinein 20ml syringe and is packed singly.