setting standards. exceeding expectations. · setting standards. exceeding expectations. contour,...

Peripheral Embolization ProductsP R O D U C T C A T A L O G A N D O R D E R I N G I N F O R M A T I O N

SETTING STANDARDS. EXCEEDING EXPECTATIONS.

Contour, Direxion, FasTracker, Fathom, Fibered IDC, HI-FLO, ICE, Imager, Interlock, Renegade, Taper, Transend, VORTEC and VortX are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.

Peripheral Interventions300 Boston Scientific WayMarlborough, MA 01752-1234www.bostonscientific.com

To order product or for more informationcontact customer service at 1.888.272.1001.

© 2018 Boston Scientific Corporationor its affiliates. All rights reserved.

PI-566007-AA JUL2018

1

B O S T O N S C I E N T I F I C

Complete Offering

Throughout our history, we’ve pioneered the development of innovative products to help physicians

improve patients’ lives. This focused approach to new Peripheral Embolization technologies, backed

by an unwavering commitment to quality, remains unchanged for over 30 years.

Peripheral Embolization Solutions

Pushable Platinum Coils

Detachable Platinum Coils

IDC™ Soft Embolization Coil

Embolic Microspheres & Particles

Renegade™ Microcatheters

Renegade™ HI-FLO™ Microcatheters

Direxion™ Torquable Microcatheters

Imager II™ Angiographic Catheters

Occlusion Balloons

2 3

Pushable 0.035" Fibered Platinum Coils• Boston Scientific’s line of pushable 0.035" coils have been engineered to facilitate robust radial force

• Pushable 0.035" coils are designed with long, dense Dacron Fibers to facilitate vessel occlusion

• Deliverable through a 5 F Imager-II 0.035" or 0.038" guidewire compatible diagnostic catheter

Multi-Loop-18 Fibered Platinum Coils

Complex Helical-18 Fibered Platinum Coils

0.035" Multi-Loop Fibered Platinum Coils

VortX-35 Vascular Occlusion Coils

UPNMaximum

Diameter (mm)Unrestrained Coil

Length (mm)Length in

Introducer (mm)Box

(units)

M0013120431 4 7.0 30 5

UPNMaximum



Introducer (mm)Box

(units)

M0013120221 4 4.0 20 5

M0013120331 6 6.0 30 5

M0013120441 7 10.0 40 5

M0013120551 8 12.0 50 5

M0013120661 10 14.0 60 5

M0013120771 11 17.0 70 5

UPNMaximum



Introducer (mm)Box

(units)

M0013723021 3 2.6 20 5

M0013723041 3 5.2 40 5

M0013724031 4 2.9 30 5

M0013725031 5 2.4 30 5

M0013725051 5 4.0 50 5

M0013726041 6 2.6 40 5

M0013727041 7 2.3 40 5

M0013729061 9 2.7 60 5

UPNMaximum



Introducer (mm)Box

(units)

M0013732041 4 4.0 30 5

M0013733051 5 4.5 35 5

M0013733061 6 5.0 53 5

M0013733071 7 5.5 67 5

Pushable 0.018" Fibered Platinum Coils• Boston Scientific’s line of pushable 0.018" coils offer wide variety of shapes that have been designed to address the unpredictable challenges of the distal vasculature

• Pushable 0.018" coils can be used in conjunction with a small lumen microcatheter, such as the Direxion Microcatheter, Renegade STC 18 Microcatheter and Renegade Fiber Braided Microcatheter

Pushable Platinum CoilsWith Boston Scientific, you can choose from a wide range of pushable platinum coils, all engineered for enhanced visibility. All Boston Scientific pushable platinum coils include dense Dacron™ Fibers intended to facilitate fast and complete occlusion, and rounded ball-weld ends designed for ease of use and to address the risk of vessel trauma.

VortX™ Diamond-18 Fibered Platinum Coils

VortX-18 Fibered Platinum Coils

Straight-18 Fibered Platinum Coils

Figure 8-18 Fibered Platinum Coils

UPNMaximum



Introducer (mm)Box

(units)

M0013822031 3 3.3 23 5

M0013822041 4 3.7 41 5

M0013822051 5 5.5 58 5

M0013822061 6 6.7 80 5

UPNMaximum



Introducer (mm)Box

(units)

M0013812031 3 2.5 22 5

M0013812041 4 4.0 42 5

M0013812051 5 5.5 60 5

M0013812061 6 6.5 85 5

UPNMaximum



Introducer (mm)Box

(units)

M0013120021 Straight 2.0 2 5

M0013122051 Straight 5.0 5 5

UPNMaximum



Introducer (mm)Box

(units)

M0013120211 2 5.0 10 5

54

Interlock-35 Fibered IDC Occlusion Systems• Available in 2D, Cube and Diamond Shapes

• Deliverable through a 5 F Imager™ II 0.035" or 0.038" guidewire compatible Diagnostic catheter

Cube

2D

Diamond

Interlock-18 Fibered IDC Occlusion Systems• Available in 2D Helical and Diamond Coil shapes, maximizing your ability to tailor coil type to anatomical need

• Deliverable through a microcatheter with a inner diameter of 0.021"

Detachable Platinum CoilsThe Interlock Fibered IDC Occlusion System features interlocking arms that allow the coil to be advanced and retracted before final placement in the vessel, thus aiding in a more controlled delivery. The long coil lengths and wide diameters provide increased procedural flexibility, helping you meet the challenges of vessel size and procedural variables.

2D Standard Length

2D Long Length

Diamond Configurations

UPN DescriptionDiameter

(mm)Length

(cm) Shape

M001361480 Interlock-18 Coil 2 4 2D


















(mm)Length

(cm) Shape







(mm)Length

(cm) Shape

M001361740 Interlock-18 Coil 2/3 2.3 Diamond





(mm)Length

(cm) Shape

M001363700 Interlock-35 Coil 4 6 Cube










(mm)Length

(cm) Shape

















(mm)Length

(cm) Shape

M001363910 Interlock-35 Coil 4 4.5 Diamond



6 7

Embolic Microspheres & Particles Embozene Microspheres are offered in ten individual colors calibrated to a specific size and available in 2 mL syringes. Oncozene Microspheres are white in color and are available in three sizes in 2 or 3 mL syringes. Contour polyvinyl alcohol (PVA) flakes are available in a wide variety of sizes and multi-pack options for flexibility in peripheral embolization procedures.

Contour™ Embolization Particles• Indicated for the embolization of hypervascular tumors including leiomyoma uteri and arteriovenous malformations

Embozene Microspheres• Embozene Microspheres are intended for embolization of arteriovenous malformations and hypervascular

tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Oncozene Microspheres• Indicated for arteriovenous malformations, hypervascular tumors and hepatoma

Order Code

Microsphere Size(Microns)

Product Volume

Microsphere Color Units Packaging

01-0301-00402-11 40 2 ml Black 1 Syringe

01-0301-00752-11 75 2 ml Red 1 Syringe

01-0301-01002-11 100 2 ml Orange 1 Syringe

01-0301-02502-11 250 2 ml Yellow 1 Syringe

01-0301-04002-11 400 2 ml Blue 1 Syringe

01-0301-05002-11 500 2 ml Maroon 1 Syringe

01-0301-07002-11 700 2 ml Green 1 Syringe

01-0301-09002-11 900 2 ml Purple 1 Syringe

01-0301-11002-11 1100 2 ml Gray 1 Syringe

01-0301-13002-11 1300 2 ml Pink 1 Syringe

Order Code

Microsphere Size(Microns)

Product Volume

Microsphere Color Units Packaging

06-0301-00402-02 40 2 ml White 1 Syringe

06-0301-00403-02 40 3 ml White 1 Syringe

06-0301-00752-02 75 2 ml White 1 Syringe

06-0301-00753-02 75 3 ml White 1 Syringe

06-0301-01002-02 100 2 ml White 1 Syringe

06-0301-01003-02 100 3 ml White 1 Syringe

Order Code

ParticleSize (microns)

Box(units Packaging

M0017600121 45-150 2 Vial

M0017600151 45-150 5 Vial

M0017600221 150-250 2 Vial

M0017600251 150-250 5 Vial

M0017600321 250-335 2 Vial

M0017600351 250-355 5 Vial

M0017600421 355-500 2 Vial

M0017600451 355-500 5 Vial

M0017600621 500-710 2 Vial

M0017600651 500-710 5 Vial

M0017600821 710-1000 2 Vial

M0017600851 710-1000 5 Vial

M0017601151 1000-1180 5 Vial

IDC Soft Embolization Coil • Soft 0.018" coil design for smooth & elegant finishing, nesting and packing

• Range of sizes, down to 2mm x 2cm, to facilitate use in extra small, tight vessels

• Deliverable through a microcatheter with an inner diameter of 0.021"

IDC™ Soft Embolization Coil The IDC Soft 0.018" detachable embolization coil leverages an interlocking arm detachment mechanism, which facilitates the ability to retract and reposition before final placement of the coil. IDC Soft features a soft coil design to enable precise placement of the coil tail and reduced risk of catheter kickback.

Order Code Description

Diameter(mm)

Length(cm) Shape

M0033612020 IDC-18 Soft 2 2 Soft 2D

M0013612040 IDC-18 Soft 2 4 Soft 2D

M0013613060 IDC-18 Soft 3 6 Soft 2D

M0013613100 IDC-18 Soft 3 10 Soft 2D

M0013614040 IDC-18 Soft 4 4 Soft 2D

M0013614080 IDC-18 Soft 4 8 Soft 2D

M0013614120 IDC-18 Soft 4 12 Soft 2D

M0013615080 IDC-18 Soft 5 8 Soft 2D

M0013615120 IDC-18 Soft 5 12 Soft 2D

8 9

Renegade STC 18 Microcatheters• 3 F proximal OD tapers to 2.4 F smooth distal tip with non-protruding RO marker and 0.021" PTFE inner lumen

• Angled and straight distal tip options, 20 and 30 cm lengths

• 1,000 psi burst pressure rating

• Compatible with all 0.018" coils, up to 700 micron sized spherical particles, and up to 500 micron non-spherical particles

Recommended microcatheter for Interlock™-18 Fibered Occlusion System and for all 0.018" pushable coils.

Renegade Microcatheter Family

Renegade Fiber Braided Microcatheters• 3 F proximal OD tapers to 2.5 F smooth distal tip with RO marker and 0.021" PTFE inner lumen

• 300 psi rated burst pressure

• VORTEC™ Fiber Braided Material intended to provide excellent flexibility

• Compatible with all 0.018" coils, up to 700 micron sized spherical particles, and up to 500 micron non-spherical particles

Renegade™ Microcatheters Boston Scientific’s Renegade™ Microcatheters provide you with the options you need to address a wide variety of challenging interventions. With exceptional distal access, outstanding flow rates, pre-shaped distal tips and pre-loaded micro-guidewires, this assortment puts the right option at your fingertips.

Order Code

Usable Length (cm)

Proximal/Distal O.D. (F)

Distal I.D. (in)

Distal Tip Length (cm)

M001182520 130 3.0/2.5 0.021 20

M001182510 150 3.0/2.5 0.021 10

M001182530 150 3.0/2.5 0.021 20

Order Code

Usable Length (cm)


Distal I.D. (in)

Distal Tip Length (in)

Tip Design

M001181270 105 3.0/2.4 0.021 20 Angled

M001181280 105 3.0/2.4 0.021 30 Angled

M001181330 130 3.0/2.4 0.021 20 Angled

M001181340 130 3.0/2.4 0.021 30 Angled

M001181390 150 3.0/2.4 0.021 20 Angled

M001181400 150 3.0/2.4 0.021 30 Angled

M001181250 105 3.0/2.4 0.021 20 Straight

M001181260 105 3.0/2.4 0.021 30 Straight

M001181310 130 3.0/2.4 0.021 20 Straight

M001181320 130 3.0/2.4 0.021 30 Straight

M001181370 150 3.0/2.4 0.021 20 Straight

M001181380 150 3.0/2.4 0.021 30 Straight

Renegade™ HI-FLO™ Microcatheters

Recommended microcatheter for Contour Embolic Particles.

Renegade HI-FLO Microcatheters• 3 F proximal OD tapers to 2.8 F polished distal tip with RO marker

• Large 0.027" PTFE inner lumen and 800 psi burst pressure rating promotes exceptional flow rates

• Fiber and metal braid designed for excellent visibility without compromising kink resistance

• Compatible with up to 900 micron spherical particles and up to 710 micron non-spherical particles

Renegade HI-FLO Microcathether Family

Order Code

Usable Length (cm)


Distal I.D. (in)

Distal Tip Length (in)

Tip Design

M001182840 105 3.0/2.8 0.027 10 Straight

M001182850 105 3.0/2.8 0.027 20 Straight

M001182860 115 3.0/2.8 0.027 10 Straight

M001182870 115 3.0/2.8 0.027 20 Straight

M001182880 135 3.0/2.8 0.027 10 Straight

M001182890 135 3.0/2.8 0.027 20 Straight

M001182900 150 3.0/2.8 0.027 10 Straight

M001182910 150 3.0/2.8 0.027 20 Straight

Renegade HI-FLO Fathom Systems (one hoop/one carton) • The Renegade HI-FLO Microcatheter is pre-loaded with a Fathom Guidewire

• Combined kit eliminates a prep-step

• The Diamond-cut nitinol hypotube of the Fathom Guidewire provides turn-for-turn torque for deft navigation of even the most tortuous vasculature

• The Renegade HI-FLO Microcatheter has a large 0.027" PTFE inner lumen, yet maintains a small 2.8 F distal tip, providing excellent deliverability, rail support, and flow rates

Order Code

Fathom-16 SteerableGuidewire

Overall Length (cm)

Fathom-16 SteerableGuidewire

Tip Length (cm)

Renegade HI-FLO Microcatheter

Usable Length (cm

Renegade HI-FLO Microcatheter

Tip Length (cm)

M001184500 140 10 105 10

M001184510 140 10 105 20

M001184520 140 10 115 10

M001184530 140 10 115 20

M001184540 180 10 135 10

M001184550 180 10 135 20

M001184560 180 10 150 10

M001184570 180 10 150 20

10 11

Boston Scientific’s Renegade Hi-FLO Microcatheter Product Portfolio provides you with the options you need to address a wide variety of challenging interventions. With the trusted Renegade HI-FLO Microcatheter platform, this family of microcatheters gives you the confidence you need to access a variety of vasculature. The Renegade HI-FLO Fathom™ System combines the unique turn-for-turn, torque response, flexibility and high visibility of the Fathom-16 Guidewire with the clinically proven performance of the Renegade HI-FLO Microcatheter, all in one convenient platform. The combination of these custom-built technologies, available for the first time in one convenient package and eight configurations, provides physicians with advanced, simple solutions for their peripheral embolization needs.

Renegade HI-FLO Transend™ Kits (two hoops/one carton)• Renegade HI-FLO Microcatheter paired with Transend-18 Guidewire

Order Code

Transend-18 Guidewire

UsableLength (cm)

Transend-18 Guidewire Shapeable

Tip Length (cm

RenegadeHI-FLO

MicrocatheterUsable Length (cm)

RenegadeHI-FLO

MicrocatheterTip Length (cm)

M001182980 135 2 105 10

M001182990 135 2 105 20

M001183000 135 2 115 10

M001183010 135 2 115 20

M001183020 165 2 135 10

M001183030 165 2 135 20

Direxion™ Torquable Microcatheters

Direxion Microcatheter Family• 2.4 F distal OD with 0.021" PTFE inner lumen

• Straight, Bern, J, or Swan shape tip options

• 1 or 2 RO markers

• Compatible with all 0.018" coils, up to 700 micron

sized spherical particles, and up to 500 micron

sized non-spherical particles

• 1200 psi burst rating

Direxion Microcatheter

Direxion Microcatheter Preloaded System with Transend-14 Guidewire

Direxion Microcatheter Preloaded System with Fathom-16 Guidewire

Order Code

OrderNumber

UsableLength (cm)

TipShape

ROMarkers)

M001195200 19-520 105 Straight 1

M001195210 19-521 130 Straight 1

M001195220 19-522 155 Straight 1

M001195230 19-523 105 Bern 1

M001195240 19-524 130 Bern 1

M001195250 19-525 155 Bern 1

M001195260 19-526 105 J 1

M001195270 19-527 130 J 1

M001195280 19-528 155 J 1

M001195290 19-529 105 Swan 1

M001195300 19-530 130 Swan 1

M001195310 19-531 155 Swan 1

M001195320 19-532 130 Straight 2

M001195330 19-533 155 Straight 2

M001195340 19-534 130 Bern 2

M001195350 19-535 155 Bern 2

Order Code

OrderNumber

DirexionTorqueable


DirexionTorqueable

Microcatheter Tip Shape

Fathom-16Guidewire

OverallLength (cm)

M001195610 19-561 130 Straight 180

M001195620 19-562 155 Straight 180

M001195640 19-564 130 Bern 180

M001195650 19-565 155 Bern 180

M001195660 19-566 130 Straight (2RO) 180

M001195670 19-567 130 Bern (2RO) 180

Order Code

OrderNumber

DirexionTorqueable


DirexionTorqueable


Transend-14Guidewire

Overall Length (cm)

M001195810 19-581 130 Straight 165

M001195840 19-584 130 Bern 165

M001195850 19-584 155 Bern 190

12 13

The Direxion Microcatheter, now with improved tip shapes and hydophilic coating, is the first microcatheter built using Boston Scientific’s slotted nitinol hypotube technology. This technology maximizes torque transmission in the catheter shaft, giving the Direxion Microcatheter best-in-class torqueability while still maintaining excellent flexibility, trackability, and pushability. The Direxion Microcatheter is also available in six unique tip configurations as well as a full line of 0.021" and 0.027" lumen pre-loaded guidewire systems with your choice of a Fathom™-16 Guidewire, Transend™-14 Guidewire, or Transend-18 Guidewire.

Direxion HI-FLO™ Microcatheter Family• 2.8 F distal OD with 0.027" PTFE inner lumen

• Straight, Bern, J, or Swan shape tip options

• Compatible with up to 900 micron sized spherical particles, and up to 710 micron sized non-spherical particles

• 1200 psi burst rating

Direxion HI-FLO Microcatheter

Direxion HI-FLO Microcatheter Preloaded System with Fathom-16 Guidewire

Direxion HI-FLO Microcatheter Preloaded System with Transend-18 Guidewire

Order Code

OrderNumber

UsableLength (cm)

TipShape

ROMarkers)

M001195400 19-540 105 Straight 1

M001195410 19-541 130 Straight 1

M001195420 19-542 155 Straight 1

M001195430 19-543 105 Bern 1

M001195440 19-544 130 Bern 1

M001195450 19-545 155 Bern 1

M001195460 19-546 105 J 1

M001195470 19-547 130 J 1

M001195480 19-548 155 J 1

M001195490 19-549 105 Swan 1

M001195500 19-550 130 Swan 1

M001195510 19-551 155 Swan 1

Order Code

OrderNumber

DirexionTorqueable


DirexionTorqueable


Fathom-16Guidewire

OverallLength (cm)

M001195710 19-571 130 Straight 180

M001195720 19-572 155 Straight 180

M001195740 19-574 130 Bern 180

M001195750 19-575 155 Bern 180

Order Code

OrderNumber

DirexionTorqueable


DirexionTorqueable


Transend-18Guidewire

OverallLength (cm))

M001195910 19-591 130 Straight 165

M001195940 19-594 130 Bern 165

Transend™ Peripheral Embolization Guidewires• Scitanium alloy core provides excellent support

• Shapeable tungsten tip enables physicians to customize guidewire

• Lubricious ICE™ Hydrophilic Coating on distal segment, for enhanced catheter tracking

• A guidewire engineered to provide torque control and flexibility

Fathom Peripheral Embolization Guidewires• New angled tip and radial access lengths

• Microfabricated nitinol hypotube designed for turn-for-turn torque

• Alternating microscopic channels balance support with flexibility

• Lubricious hydrophilic coating on distal segment and PTFE coating on stainless steel segment intended to facilitate guidewire placement and catheter tracking

• Highly visible, shapeable platinum/tungsten tip available in straight and angled profiles

Order Code

TotalLength (cm)

TipLength (cm)

DistalFloppy TipLength (cm)

Proimal/Distal O.D. (in) Tip Shape

New Tip Shapes and Lengths Fathom™ -16 Steerable Guidewires

M001509120 180 25 10 0.016 Angled

M001509200 200 25 10 0.016 Straight

M001509210 200 25 10 0.016 Angled

M001509300 215 25 10 0.016 Straight

M001509310 215 25 10 0.016 Angled

Fathom™ -16 Steerable Guidewires

M001509000 140 25 10 0.016 Straight

M001509010 140 35 20 0.016 Straight

M001509100 180 25 10 0.016 Straight

M001509110 180 35 20 0.016 Straight

Fathom -14 Steerable Guidewires

M001508100 200 35 10 0.014 Straight

M001508110 200 35 10 0.014 Angled

M001508140 300 35 10 0.014 Straight

M001508150 300 35 10 0.014 Angled

Order Code

TotalLength (cm)

ShapeableTip Length (cm)

ProximalO.D. (in)

DistalO.D. (in)

M001468100 135 2 0.014 0.014

M001468110 165 2 0.014 0.014

M001468010 190 2 0.014 0.014

M001468120 135 2 0.018 0.018

M001468130 165 2 0.018 0.018

Guidewires The Fathom™ Guidewires are designed to address a variety of clinical practice situations and are available in distinct profile configurations for challenging procedures. Available in 0.014" and 0.016" sizes, Fathom Guidewires combine a nitinol hypotube distal segment with advanced microfabrication technology, creating a design that revolutionizes access of the most tortuous vasculature.

14 15

Cerebral CurvesHeadhunterCommonly used for carotid, innominate andsubclavian access

SimmonsFacilitates access of common carotid, subclavian, renal and contralateral common iliac

NewtonDramatic double “S” curve designed for largeraortic arches

JBLightly curved tips for access to carotid arteries

Other Cerebral Curves

ST

BARNCommonly used for guide wire redirect

BERNFacilitates access of the great vessels

GENDesigned with a gentle curve

WEINGentle curve for guide wire redirect

H1 H3 H1H

SIM1 SIM2 SIM3 SIM4

HN1 HN2 HN3

HN4 HN5

Imager II™ Angiographic Catheters The 5F selective offerings of Imager II Angiographic Catheters include a wide variety of cerebral and visceral shapes designed to provide the versatility required for a wide variety of peripheral embolization needs. The catheters feature an advanced braided shaft designed to promote kink resistance and pushability to ease advancement through tortuous and distal anatomy, and predictable torque response designed to facilitate exact positioning of the catheter tip.

Imager II• Recommended for the delivery of the Interlock-35 Fibered IDC Occlusion System

• 40, 65, and 100cm catheter length options

• 0.035" and 0.038" guidewire compatible options

• Variety of cerebral and visceral tip shapes available

Imager II - 5 F Select Catheters Braided Torque Cerebral Selective Catheters

GTIN(1 per box)

UPN(1 per box)

French(F)

Length(cm)

TipGuidewire

compatibility (in)

Max Flow Rate

(mL/sec)Box

(units)

8714729354826 M001314001 5 65 ST 0.038 20 5

8714729354833 M001314011 5 100 ST 0.038 18 5

8714729354840 M001314021 5 65 ST 0.035 20 5

8714729354857 M001314031 5 100 ST 0.035 18 5

8714729354864 M001314041 5 100 BARNH 0.038 18 5

8714729354871 M001314051 5 100 BERN 0.038 18 5

8714729354888 M001314061 5 100 BERN 0.035 18 5

8714729354895 M001314071 5 40 BERN 0.035 20 5

8714729354901 M001314081 5 40 BERN 0.038 20 5

8714729354918 M001314091 5 65 BERN 0.035 20 5

8714729354925 M001314101 5 65 BERN 0.038 20 5

8714729354932 M001314111 5 100 WEIN 0.038 12 5

8714729354949 M001314121 5 100 WEIN 0.035 12 5

8714729354956 M001314131 5 65 H1 0.038 20 5

8714729354963 M001314141 5 100 H1 0.038 12 5

8714729354970 M001314151 5 100 H1 0.035 12 5

8714729354987 M001314161 5 100 H3 0.038 12 5

8714729354994 M001314171 5 100 H3 0.035 12 5

8714729355007 M001314181 5 100 H1H 0.038 12 5

8714729355014 M001314191 5 100 H1H 0.035 12 5

8714729355038 M001314211 5 65 JB1 0.038 20 5

8714729355045 M001314221 5 100 JB1 0.038 12 5

8714729355052 M001314231 5 100 JB1 0.035 12 5

8714729355069 M001314241 5 100 JB2 0.038 12 5

8714729355076 M001314251 5 100 JB2 0.035 12 5

8714729355083 M001314261 5 100 JB3 0.038 12 5

8714729355090 M001314271 5 100 JB3 0.035 12 5

8714729355120 M001314301 5 65 SIM1 0.038 20 5

8714729355137 M001314311 5 65 SIM1 0.035 20 5

8714729355144 M001314321 5 100 SIM1 0.038 20 5

8714729355328 M001314501 5 100 GEN 0.035 18 5

16 17

Imager II - 5 F Select Catheters Braided Torque Cerebral Selective Catheters (continued)

GTIN(1 per box)

UPN(1 per box)

French(F)

Length(cm)

TipGuidewire

compatibility (in)

Max Flow Rate

(mL/sec)Box

(units)

8714729355151 M001314331 5 100 SIM1 0.035 20 5

8714729355168 M001314341 5 100 SIM2 0.038 20 5

8714729355175 M001314351 5 100 SIM2 0.035 20 5

8714729355182 M001314361 5 100 SIM3 0.038 20 5

8714729355199 M001314371 5 100 SIM3 0.035 20 5

8714729355212 M001314391 5 100 HN1 0.038 10 5

8714729355229 M001314401 5 100 HN1 0.035 10 5

8714729355236 M001314411 5 100 HN2 0.038 10 5

8714729355243 M001314421 5 100 HN2 0.035 10 5

8714729355250 M001314431 5 100 HN3 0.038 10 5

8714729355267 M001314441 5 100 HN3 0.035 10 5

8714729355274 M001314451 5 100 HN4 0.038 10 5

8714729355281 M001314461 5 100 HN4 0.035 10 5

8714729355298 M001314471 5 100 HN5 0.038 10 5

8714729355304 M001314481 5 100 HN5 0.035 10 5

8714729355328 M001314501 5 100 GEN 0.035 18 5

CobraCommonly used to access abdominal aortic vessels and internal iliacs

RenalBest suited for steeply angled renal arteries

ChuangLonger tips facilitate distal access to the celiac and mesenteric systems

Visceral Curves

MIKAssists with access toperpendicular ostia

TRAINFacilitates in antegrade access of branch vessels

HK1.0An open J configuration for access to abdominalaortic branch vessels

CONTRA 2Commonly used for contralateral access

Other Visceral Curves

C1

C2

C3

RC1

RC2

RDC

CHGB

CHGC

CHG2.5

SHK 0.8Flared tip facilitates contratateral access

SHK1.0Commonly used for contralateral access

Imager II™ Angiographic Catheters

18 19

Imager II - 5 F Select Catheters Braided Torque Visceral Selective Catheters

GTIN(1 per box)

UPN(1 per box)

French(F)

Length(cm)

TipGuidewire

compatibility (in)

Max Flow Rate

(mL/sec)Box

(units)

8714729355342 M001314521 5 65 CHGB 0.038 10 5

8714729355359 M001314531 5 65 CHGB 0.035 10 5

8714729355366 M001314541 5 65 CHGC 0.035 10 5

8714729355373 M001314551 5 65 CHGC 0.035 10 5

8714729355380 M001314561 5 65 CHG2.5 0.038 10 5

8714729355397 M001314571 5 65 CHG2.5 0.035 10 5

8714729355403 M001314581 5 65 CONTRA 2 0.038 10 5

8714729355410 M001314591 5 65 CONTRA 2 0.035 10 5

8714729355441 M001314621 5 65 C1 0.038 20 5

8714729355458 M001314631 5 65 C1 0.035 20 5

8714729355489 M001314661 5 65 C2 0.038 20 5

8714729355496 M001314671 5 65 C2 0.035 20 5

8714729355526 M001314701 5 65 C3 0.038 20 5

8714729355533 M001314711 5 65 C3 0.035 20 5

8714729355571 M001314751 5 65 TRAIN 0.038 20 5

8714729355588 M001314761 5 65 MIK 0.038 10 5

8714729355595 M001314771 5 65 MIK 0.035 10 5

8714729355601 M001314781 5 65 HK1.0 0.038 10 5

8714729355618 M001314791 5 65 HK1.0 0.035 10 5

8714729355625 M001314801 5 65 SHK0.8 0.038 10 5

8714729355632 M001314811 5 65 SHK0.8 0.035 10 5

8714729355649 M001314821 5 65 SHK1.0 0.038 10 5

8714729355656 M001314831 5 65 SHK1.0 0.035 10 5

8714729355663 M001314841 5 65 RC1 0.038 10 5

8714729355670 M001314851 5 65 RC1 0.035 10 5

8714729355687 M001314861 5 65 RC2 0.038 10 5

8714729355694 M001314871 5 65 RC2 0.035 10 5

8714729355700 M001314881 5 65 RDC 0.038 20 5

8714729355717 M001314891 5 65 RDC 0.035 20 5

Berenstein Occlusion Balloons• Compliant latex material allows for inflation to either 8.5 mm or 11.5 mm diameters

• Non-tapered catheter shaft designed to facilitate the coaxial use of small catheters or embolics

Standard Occlusion Balloons• Soft, compliant latex material designed to increase balloon burst strength during multiple inflations

• Multiple shaft lengths designed to optimize procedural efficiency

Occlusion Balloons

Occlusion Balloons

Order Code

Size(F) Lumens

Usable Length (cm)

RecommendedGuidewire

Inflated Balloon Diameter (mm)

M001171020 7 2 65 0.038 11.5

M001171030 7 2 100 0.038 11.5

Order Code

Size(F) Lumens

Usable Length (cm)

RecommendedGuidewire

Inflated Balloon Diameter (mm)

M001173010 6 2 80 0.038 8.5/11.5

Contour, Direxion, FasTracker, Fathom, Fibered IDC, HI-FLO, ICE, Imager, Interlock, Renegade, Taper, Transend, VORTEC and VortX are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.

CONTOUR™ EMBOLIZATION PARTICLESCAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The Contour Embolization Particles are used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri. CONTRAINDICATIONS: Contraindications Specific to All Peripheral Indications 1. Vascular anatomy or blood flow precludes stable, selective Contour Embolization Particles or catheter placement 2. Presence of vasospasm 3. Presence of hemorrhage 4. Presence of severe atheromatous disease 5. Presence of feeding arteries smaller than distal branches from which they emerge 6. Presence of collateral vessel pathways potentially endangering normal territories during embolization 7. Presence of arteries supplying the lesion not large enough to accept Contour Embolization Particles 8. Vascular resistance peripheral to the feeding arteries precluding passage of Contour Embolization Particles into the lesion 9. In large diameter arteriovenous shunts 10. In the pulmonary vasculature 11. Patient intolerance to occlusion procedures Contraindications Specific to Uterine Fibroid Embolization (UFE) 1. Pregnant women 2. Suspected pelvic inflammatory disease or any other active pelvic infection 3. Any malignancy of the pelvic region 4. Endometrial neoplasia or hyperplasia 5. Presence of one or more submucosal fibroid(s) with more than 50% growth into the uterine cavity 6. Presence of pedunculated serosal fibroid as the dominant fibroid(s) 7. Fibroids with significant collateral feeding by vessels other than the uterine arteries WARNINGS AND PRECAUTIONS: Warnings Applicable to All Peripheral Indications • PRIOR TO EMBOLIZATION, PROSPECTIVE PATIENTS OR THEIR REPRESENTATIVES MUST BE PROVIDED AN INFORMED CONSENT DESCRIBING THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE. WRITTEN ACKNOWLEDGMENT IS WARRANTED. • The safety and effectiveness of Contour Embolization Particles for neurovascular use have not been established. • As with any embolization device, patient injury, permanent disability or death may occur as a result of its use. • Vascular occlusion should only be performed by physicians possessing skilled interventional occlusion experience in the territory intended to be embolized. • A thorough evaluation of a patients medical condition, vascular pathways and the desired embolization goal is necessary to achieve successful occlusion. This evaluation should include baseline angiography to determine the presence of potentially dangerous collateral pathways. • Postprocedural patient follow-up to assess the continued level of vascular occlusion is necessary. Angiography may be indicated. Precautions Applicable to All Indications • Patients with known allergy to contrast medium may require pre-medication prior to embolization. • Additional evaluations or precautions may be necessary in managing periprocedural care for patients with the following conditions: A. Bleeding diathesis or hypercoagulative state; B. Immunocompromised. • The use of sophisticated imaging equipment is necessary for successful embolization therapy. • Appropriate facilities should be available to treat potential complications of the procedure. • While it is anticipated that long-term embolization of vascular structures with Contour™ Embolization Particles will be achieved, no guarantee of permanence, cure or benefit can be made. UFE Specific Warnings for Pregnancy (Specific for Treatment of Leiomyoma Uteri) • UFE is not intended for women who desire future pregnancy. The effects of UFE on the ability to become pregnant and carry a fetus to term, and on the development of the fetus, have not been determined. Therefore, this procedure should only be performed on women who do not intend future pregnancy. • Women who become pregnant following UFE, should be aware that they may be at increased risk for preterm delivery, cesarean delivery, malpresentation (incorrect positioning of the baby), and postpartum hemorrhage (post-delivery bleeding). • Devascularization of uterine myometrium resulting from UFE may put women who become pregnant following UFE at increased risk of uterine rupture. Other UFE Specific Warnings • Devascularization of uterine myometrium resulting from UFE may put women at increased risk of uterine rupture. • The diagnosis of uterine sarcoma could be delayed by taking a non-surgical approach (such as UFE), to treat uterine fibroids. Conduct a more thorough work-up for patients with warning signs for sarcoma (e.g., prior pelvic radiation, MRI findings, rapid tumor growth, postmenopausal with new uterine enlargement). Recurrent or continued tumor growth following UFE should be considered a potential warning sign for sarcoma and surgery should be considered. UFE Specific Precautions • It is recommended that patients undergoing embolization of leiomyoma uteri be provided a clear understanding of who will provide post-procedure care prior to the embolization procedure. • UFE should only be performed by physicians who have received appropriate training for treatment of uterine leiomyomata (fibroids). • There is an increased chance of retro-migration of Contour Embolization Particles into unintended blood vessels as uterine artery flow diminishes. Embolization should be stopped when the vasculature surrounding the fibroid can no longer be visualized but before complete stasis in the uterine artery. POTENTIAL COMPLICATIONS: Complications specific to embolization include, but may not be limited to: 1. Foreign body reactions (i.e. pain, rash) necessitating medical intervention 2. Allergic reaction to contrast media 3. Infection necessitating medical intervention 4. Complications related to catheterization (e.g., hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgment, vasospasm and nerve and/or circulatory injuries, which may result in leg injury) 5. Undesirable reflux or passage of Contour™ Embolization Particles into arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds 6. Ischemia at an undesirable location 7. Incomplete occlusion of vascular beds or territories may give rise to the possibility of post procedural hemorrhage, development of alternative vascular pathways, recanalization or recurrence of symptoms 8. Vessel or lesion rupture and hemorrhage 9. Recurrent hemorrhage 10. Ischemic stroke or myocardial infarction 11. Death Potential Complications Specific to UFE 1. Postembolization syndrome 2. Vaginal Discharge 3. Tissue passage, fibroid sloughing or fibroid expulsion post-UFE 4. Temporary or permanent stopping of menstrual bleeding 5. Infection of the pelvic region 6. Endometrial atrophy with amenorrhea despite normal ovarian function 7. Complications to pregnancy 8. Premature Ovarian Failure (i.e., menopause) 9. Uterine/Ovarian necrosis 10. Uterine Rupture 11. Post-UFE Intervention to remove necrotic fibroid tissue 12. Hysterectomy

DIREXION™ AND DIREXION HI-FLO™ TORQUEABLE MICROCATHETERS CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel. CONTRAINDICATIONS: None known. • Never advance or withdraw an intravascular device against resistance until the cause of resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in damage or separation of the microcatheter or guidewire tip, or vessel perforation. • This Direxion Microcatheter family is not intended for use in the coronary vasculature or neurovasculature. • The Direxion HI-FLO Microcatheter is not designed for the delivery of embolic coils. • Use of excessive force to manipulate the microcatheter against resistance can cause a fracture in the nitinol shaft. Take care not to over-torque the microcatheter, and to relieve any tension before withdrawal by rotating the microcatheter in the opposite direction. PRECAUTIONS: • This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures. • Do not introduce the microcatheter without guidewire support as this may cause damage to the proximal shaft of the catheter. • Because the microcatheter may be advanced into narrow sub-selective vasculature, repeatedly assure that the microcatheter has not been advanced so far as to interfere with its removal. ADVERSE EVENTS: The Adverse Events include, but are not limited to: • Allergic reaction • Death • Embolism • Hemorrhage/Hematoma • Infection • Pseudoaneurysm • Stroke • Vascular thrombosis • Vessel occlusion • Vessel spasm • Vessel trauma (dissection, perforation, rupture)

FATHOM-14 STEERABLE GUIDEWIRE CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The FATHOM-14 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures. CONTRAINDICATIONS: None known. WARNINGS: The FATHOM Steerable Guidewire is not intended for use in the coronary vasculature or the neuro vasculature. ADVERSE EVENTS: Complications attributed to endovascular procedures are the following: • Vessel trauma • Vessel damage • Embolism (catheter/device, air bubble, plaque, thrombus, air embolism, thromboembolism) • Pseudoaneurysm • Seizure/stroke • Vessel dissection • Hematoma at the puncture site • Nerve injury • Infection • Perforation of the vessel • Vessel spasm • Hemorrhage • Vascular thrombosis • Vessel occlusion • Death • Bleeding • Failed treatment • Inability to position guidewire • Damage to the catheter.

FATHOM-16 STEERABLE GUIDEWIRE CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The FATHOM-16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures. CONTRAINDICATIONS: None known. WARNINGS: The FATHOM Steerable Guidewire is not intended for use in the coronary vasculature or the neuro vasculature. ADVERSE EVENTS: Complications attributed to endovascular procedures are the following: • Vessel trauma • Vessel damage • Embolism (catheter/device, air bubble, plaque, thrombus, air embolism, thromboembolism) • Pseudoaneurysm • Seizure/stroke • Vessel dissection • Hematoma at the puncture site • Nerve injury • Infection • Perforation of the vessel • Vessel spasm • Hemorrhage • Vascular thrombosis • Vessel occlusion • Death • Bleeding • Failed treatment • Inability to position guidewire • Damage to the catheter

IMAGER™ II ANGIOGRAPHIC CATHETER CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The IMAGER II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system, including the carotid arteries. Additionally, the 5F Selective IMAGER II Angiographic Catheters without side holes can also be used for the controlled and selective delivery of the Boston Scientific Interlock-35 Detachable Coils into the peripheral vasculature. CONTRAINDICATIONS: No known contraindications. WARNINGS:• Angiographic catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications, and risks associated with diagnostic angiography is necessary before performing this procedure. • Accordingly, the IMAGER II Angiographic Catheters should only be used by physicians with a thorough understanding of angiographic procedures. • Due to the various sizes and shapes, and the relative stiffness of angiographic catheters, extreme care must be taken when selecting and using the IMAGER II Angiographic Catheters to avoid damage to the vessel walls through which this catheter passes. • Do not exceed the pressure ratings printed on the device labeling. Catheter integrity may be compromised if pressure limits are exceeded. • The risk associated with IMAGER II Angiographic Catheters outside the intended use is not known. PRECAUTIONS: • Precautions to prevent or reduce clotting should be taken when any catheter is used in the vascular system. The catheter should always be filled with either heparinized saline solution or contrast medium. Use of systemic heparinization should be considered.ADVERSE EVENTS: Potential adverse events (in alphabetical order) which may be associated with the use of angiographic catheters include but are not limited to: • Access Site Related Trauma • Arteriovenous Fistula • Embolism • Hemorrhage • Infection • Ischemia • Neurological Deficit Including Stroke • Plaque Dislodgment • Pseudoaneurysm • Thrombus Formation • Vasospasm • Vessel Occlusion • Vessel Wall Damage/Dissection/Perforation/Rupture

INTERLOCK FIBERED IDC OCCLUSION SYSTEM CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions INTENDED USE/INDICATIONS FOR USE: The Interlock IDC Occlusion System is a modified interlocking detachable coil. The Interlock IDC Occlusion Systems are indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. These devices are not intended for neurovascular use. CONTRAINDICATIONS:None known. PRECAUTIONS: Do not attempt to use the Interlock-35 Fibered IDC Occlusion System with a soft-walled delivery catheter. Do not advance the Interlock IDC Occlusion System if it becomes lodged within the catheter. Determine the cause of the resistance and replace the catheter and coil if necessary. ADVERSE EVENTS: The complications that may result from a peripheral embolization procedure include, but are not limited to: • Complications related to catheterization (e.g., hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgement, nerve and vessel dissection or perforation, etc.) • Pain • Hemorrhage • Infection necessitating medical intervention • Foreign body reactions necessitating medical intervention • Emboli • Ischemia • Vasospasm • Tissue necrosis • Undesirable clot formation of the vasculature • Recanalization • Death • Temporary neurological deficit

OCCLUSION BALLOON CATHETER CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: Boston Scientific Occlusion Balloon Catheters are indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. The Occlusion Balloon Catheter product line consists of two specific designs–Standard and Berenstein Occlusion Balloon Catheters. Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents. CONTRAINDICATIONS: Boston Scientific Occlusion Balloon Catheters are not designed for use in embolectomy procedures. Boston Scientific Occlusion Balloon Catheters are not designed for use as vascular flow-directed catheters (Swan-Ganz type). Any use for procedures other than those indicated in the instructions is not recommended. PRECAUTIONS: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. ADVERSE EVENTS: The complications that may result from an occlusion balloon procedure include: • vessel perforation • vessel spasm • hemorrhage • hematoma • arrhythmias/bradycardia • sepsis or infection • systemic embolization • short-term hemodynamic deterioration or instability • death • vascular thrombosis • allergic reactions to contrast medium • pyrogenic reaction • arteriovenous fistula • thromboembolic episodes • vessel dissection • air embolism

RENEGADE STC 18 MICROCATHETER RENEGADE FIBER BRAIDED MICROCATHETER RENEGADE HI-FLO MICROCATHETER CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The Renegade STC 18 Microcatheter, Renegade Fiber Braided Microcatheter, and the Renegade HI-FLO Microcatheter are intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, therapeutic agents to be used in accordance with specifications outlined by the manufacturer. CONTRAINDICATIONS: None Known. WARNING: The Renegade STC 18 Microcatheter, Renegade Fiber Braided Microcatheter, and the Renegade HI-FLO Microcatheter are not intended for use in the coronary vasculature or the neurovasculature. PRECAUTIONS: • This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures. • Never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy. Movement of the microcatheter or guidewire against resistance may result in separation of the microcatheter or guidewire tip, damage to the microcatheter or guidewire tip, or vessel perforation. • Because the microcatheter may be advanced into narrow subselective vasculature, repeatedly assure that the microcatheter has not been advanced so far as to interfere with its removal. ADVERSE EVENTS: The Adverse Events include, but are not limited to: • Vessel trauma • Embolism • Hemorrhage/Hematoma • Vasospasm • Infection • Air embolism • Allergic reaction

TRANSEND™ GUIDEWIRE WITH ICE™ HYDROPHILIC COATINGCAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The Transend Guidewire is intended for general intravascular use, including the peripheral vasculature. The wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. CONTRAINDICATIONS: This device is not intended for use in coronary arteries. PRECAUTIONS: • This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures. ADVERSE EVENTS: Complications attributed to guidewire applications are the following: • Procedural related complications including but not limited to: • Vessel trauma • Vessel damage • Air embolism, thromboembolism • Post embolization syndrome (abdominal pain, fever, and nausea/vomiting) • Hematoma at the puncture site • Infection • Perforation of the vessel • Vessel spasm • Hemorrhage • Vascular thrombosis • Death • Bleeding • Failed treatment • Inability to position guidewire • Damage to catheter • Excessive force against resistance may result in separation of the guidewire tip

COILS 18-VORTX DIA STRT FIG8 MULTILP CH CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: Boston Scientific’s 0.018 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature. The Coil Pusher-16 is intended to be used in conjunction with a microcatheter to deliver and deploy 0.018 pushable occlusion coils. CONTRAINDICATIONS: None known. PRECAUTIONS: • The long-term effect of this product on extravascular tissues has not been established, so care should be taken to retain this device in the intravascular space. • Do not advance the coil with force if the coil becomes lodged within the microcatheter. Determine the cause of resistance and replace the microcatheter and the coil when necessary. • Replace the microcatheter if increased resistance is noted during coil delivery. ADVERSE EVENTS: The complications that may result from a peripheral embolization procedure include, but are not limited to: • Complications related to catheterization (e.g., hematoma at the site of entry, vessel injury, etc.) • Death • Emboli • Foreign body reactions necessitating medical intervention • Hemorrhage • Infection necessitating medical intervention • Ischemia • Pain • Recanalization • Temporary neurological deficit • Tissue necrosis • Undesirable clot formation of the vasculature • Vasospasm

COILS - VORTX 35 2D HELICAL 35 CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: VortX-35 and 2D Helical-35 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature. CONTRAINDICATIONS: None known. WARNINGS: Never advance the guidewire after coil has been deposited. Advancing the guidewire after the coil has been deposited risks damaging the vessel. PRECAUTIONS: In preclinical studies, the use of this device has been associated with a minor chronic inflammation of a giant cell foreign body reaction. Although inflammation of this type has not been observed in humans, the long term clinical significance of this type of inflammatory response, if any, is unknown. The long term effect of this product on extravascular tissues has not been established, so care should be taken to retain this device in the intravascular space. Do not advance the coil with force if the coil becomes lodged within the catheter. Determine the cause of resistance and replace the catheter and the coil when necessary. Replace catheter frequently if increased resistance is noted during coil delivery. ADVERSE EVENTS: The complications that may result from a peripheral embolization procedure include, but are not limited to: • Complications related to catheterization (e.g., hematoma at the site of entry, vessel injury, etc.) • Death • Emboli • Foreign body reactions necessitating medical intervention • Hemorrhage • Infection necessitating medical intervention • Ischemia • Pain • Recanalization • Temporary neurological deficit • Tissue necrosis • Undesirable clot formation of the vasculature • Vasospasm

EMBOZENE™ MICROSPHERESINDICATIONS FOR USE: Embozene Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). CONTRAINDICATIONS: The contraindications of Embozene Microspheres include the presence of vasculature where Embozene™ Microspheres could pass directly into the central nervous system, central circulatory system, internal carotid artery, or other non-target territories. Procedures should not be performed if vascular anatomy precludes correct catheter placement or embolic injection. WARNINGS AND PRECAUTIONS: Vascular embolization is a high-risk procedure. The procedure should be performed by specialized physicians trained in vascular embolization procedures. Complications can occur at any time during or after the procedure.CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. A complete list of indications, contraindications, warnings and precautions are described in Embozene™ Microspheres Instructions for Use. Please consult these before using the product. Embozene is a unregistered or registered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.

ONCOZENE™MICROSPHERESINDICATIONS FOR USE: ONCOZENE™ Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including hepatoma. CONTRAINDICATIONS: The contraindications of ONCOZENE™ Microspheres include the presence of vasculature where ONCOZENE™ Microspheres could pass directly into the central nervous system, central circulatory system, internal carotid artery, or other non-target territories. Procedures should not be performed if vascular anatomy precludes correct catheter placement or embolic injection. WARNINGS AND PRECAUTIONS: Vascular embolization is a high-risk procedure. The procedure should be performed by specialized physicians trained in vascular embolization procedures. Complications can occur at any time during or after the procedure.CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. A complete list of indications, contraindications, warnings and precautions are described in ONCOZENE™ Microspheres Instructions for Use. Please consult these before using the product. Oncozene is a unregistered or registered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.

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