Target Detachable Coils - AngioCalc · ta™ngibn Advan Advv Advdan Glass model results may not necessarily be indicative of clinical performance. All photographs taken by and on

Advance with Confidence

Target™ Detachable Coils withTenzing™Technology

BSN-054 Target Brochure Revise M10b.indd 1 10/28/10 4:39 PM

The Formula for Exceptional Performance

Introducing a revolutionary formula for product development. With Tenzing Technology, quality, process, and design come together to create a platform where no single feature stands alone. Each element of the Target system has been optimized to work together, resulting in exceptional coil performance. Experience Tenzing Technology.

INZONEtm DEtACHmENt SYStEm Streamlines the detachment process with increased speed, direct feedback, and greater control

BIpOlAr pAtHwAYCentralized electrodes allow for quicker system setup by eliminating the need for a grounding cable and needle

GDC tArGEt

FlEXIBlE JUNCtION Softer, shorter junction engineered to minimize kickback for increased control and stability

Confidence in Innovation

PROCESS

D E S I G N

QU

ALIT

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TENZING™

TECHNOLOGY

COmprEHENSIvE OFFErING

The Target Detachable Coil family provides an expanded suite of 10-size 360 and helical coils, including longer lengths and the first bare 360 finishing coil in the 360 Ultra

ImprOvED StrEtCH rESIStANCE Reinforced suture connection enables confident and controlled repositioning

mICrOCAtHEtEr COmpAtIBIlItY

Updated profile passes through an Excelsior® SL-10TM

Microcatheter with reduced snaking

Target™

Detachable Coils

PROCESS

D E S I G N

QU

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TENZING™

TECHNOLOGY

COIL FEATURES

Page 2 © medicalvision

16. Sep.2009Date:Project:Client:

Target Helical several

L07_Target Helical with SR Suture

tArGEt DEtACHABlE COIl

GDC® DEtACHABlE COIl

HYBrID DElIvErY wIrEBalanced stiffness zones provide an optimized combination of flexibility and pushability to yield a one-to-one feel

DArkEr rADIOpAqUE mArkErS Enhances visibility to facilitate accurate alignment

FlUOrO-SAvEr mArkEr Intended to reduce radiation exposure time for physicians and patients

with the InZone™ Detachment System

lASEr-ABlAtED DEtACHmENt ZONE New design uses 82% less metal for fast detachments with no compromise to tensile strength

BSN-054 Target Brochure Revise M10b.indd 2-3 10/28/10 4:40 PM

1.00

25.0

30.0

20.0

15.0

10.0

5.0

0.0

0.80

TARGET ZONEPUSH

ZONE

GDC®

Delivery Wire

TargetDelivery Wire

FLEX ZONE

0.60 0.40

Push

abili

ty (

gf)

Flexibility (Nmm2)

0.20

66%

M

ore

Push

able

36% More Flexible

pUShAbILITy vS. FLEXIbILITy

Confidence You Can Feel

FlEXIBIlItY (Nmm2)Ability to bend–Force required to deflect the tip

of the delivery wire 1cm off of a straight path(n=5)

Bench test data. Bench test results may not necessarily be indicative of clinical performance.Testing completed by Boston Scientific Corp. Data on file and available upon request.

pUSHABIlItY (gf) Ability to transmit force–

Force output at the distal end of the delivery wire

when pushed with 60g of force at the proximal end

(n=5)

0.0 10.0 20.0 30.0 50.040.0

TARGET ZONE

24% More Trackable

trACkABIlItY (gf)Ability to advance through a tortuous path — Force required to push the

coil a fixed distance of 15cm within an Excelsior SL-10 Microcatheter(n=10)

target Helical Ultra 2mm x 6cm Coil

GDC-10 UltraSoft®

2mm x 6cm Coil

The Target™ Detachable Coil delivery wire is engineered to optimize both pushability and flexibility, resulting in a new level of tactile sensation.

Balanced Design

Experience the difference of Target™ Detachable Coils throughout the entire delivery process — from enhanced trackability through the microcatheter, to smoother coil positioning, and improved stability upon marker alignment.

Controlled Delivery


Coil deployment into a 4mm x 4mm silicone aneurysm model.All photographs taken by and on file at Boston Scientific Corp.

GDC Detachable Coil protocol: Coil 1, GDC-10 360° Soft 4mm x 8cm; Coil 2, GDC-10 360° Soft 3mm x 6cm; Coil 3, GDC-10 UltraSoft 2mm x 6cm.Target Detachable Coil protocol: Coil 1, Target 360 Soft 4mm x 8cm; Coil 2, Target 360 Soft 3mm x 6cm; Coil 3, Target Helical Ultra 2mm x 6cm.

GDC-10 UltraSoft 2mm x 6cm Coil

target Helical Ultra 2mm x 6cm Coil

140%

120%

100%

80%

60%

40%

20%

0%

CHA

NG

E IN

FO

RCE

REQ

UIR

ED

TO D

EPLO

Y CO

IL (%

)

AMOUNT OF COIL DEPLOYED (CM)(n=5)

Target Helical Ultra 2mm x 6cm Coil

GDC-10 UltraSoft2mm x 6cm Coil

0 1 2 3 4 5 6

5xSmoother

DELIVERY WIRE FORCE CHANGE DURING COIL DEPLOYMENT

ENhANCED TRACkAbILITyUpdated profile decreases force required to advance the coil through an Excelsior® SL-10TM Microcatheter

SMOOTh pOSITIONINGRedesigned delivery wire reduces the build-up and release of force experienced during coil deployment

IMpROvED MICROCAThETER STAbILITyShort, flexible junction minimizes kickback for sustained access to the aneurysm during marker alignment

PROCESS

D E S I G N

QU

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TENZING™

TECHNOLOGY

ADvANCE

DEplOY

AlIGN


Confidence You Can Trust

Our softest complex coil ever.The Target 360 Ultra Detachable Coil unites finishing-coil softness with the Gold Standard in shape. Experience the benefits of 360 from Start to Finish.

Target™ 360 Ultra Coil

GREATER CONFORMABILITY

INCR

EASI

NG

SO

FTN

ESS

GREATER STABILITY

0%

COIL SOFTNESS

RELATIVE SOFTNESS LEVELS (%)—COMPARED TO TARGET 360 STANDARD 5% COMPRESSION (n=5)

Target Helical Ultra4mm

Target 360 Ultra4mm

Target 360 Soft4mm

Target 360 Standard4mm

20% 40% 60% 80% 100%

2x Softer

2x SofterINCREASED DURAbILITy

ImprOvED StrEtCH rESIStANCE Reinforced suture connection enables confident repositioning during coil deployment

ENHANCED JUNCtION StrENGtH Reengineered junction provides increased tensile strength for secure delivery

Our CommitmentAt Boston Scientific, we are committed to patient safety and customer satisfaction. That's why Target™ Detachable Coils are subjected to rigorous testing and designed for increased product durability. Advance with Confidence.

0.60

0.50

0.40

0.30

0.20

0.10

0.00

STRETCH RESISTANCE

STRE

TCH

FO

RCE

REQ

UIR

ED T

O B

REA

K SU

TURE

(lbf)

0.60

0.50

0.40

0.30

0.20

0.10

JUNCTION STRENGTH

STRE

TCH

FO

RCE

REQ

UIR

ED T

O B

REA

K JU

NCT

ION

(lb

f)

Target 360Standard

11mm x 30cm Coil(n=22)

GDC 360Standard


20% Stronger Junction4.5x

More Stretch

Resistant

Target CoilSR Suture

(n=5)

GDC® Coil SR Suture

(n=5)

cxm mm

0.60

0.50

0.40

0.30

0.20

0.10

0.00

STRETCH RESISTANCE

STRE

TCH

FO

RCE

REQ

UIR

ED T

O B

REA

K SU

TURE

(lbf)

0.60

0.50

0.40

0.30

0.20

0.10

JUNCTION STRENGTH

STRE

TCH

FO

RCE

REQ

UIR

ED T

O B

REA

K JU

NCT

ION

(lb

f)

Target 360Standard


GDC 360Standard


20% Stronger Junction4.5x

More Stretch

Resistant

Target CoilSR Suture

(n=5)

GDC® Coil SR Suture

(n=5)

cxm mm

RIGOROUS TESTING

ThE 360 DIFFERENCE

During the Target Detachable Coil development project, more than 20,000 units were built and tested to meet precise specifications for product quality.

CONCENtrIC FIllING

UNIFOrm DIStrIBUtION

NECk COvErAGE

FRAME FILL FINISHGlass model results may not necessarily be indicative of clinical performance.All photographs taken by and on file at Boston Scientific.

Bench test data. Bench test results may not necessarily be indicative of clinical performance.

Testing completed by Boston Scientific Corp. Data on file and available upon request.


FINIShING SOFTNESS

START TO FINISh

PROCESS

D E S I G N

QU

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TENZING™

TECHNOLOGY

20,000 COIlS


pAGE 6 pAGE 7

Confidence You Can Deliver

ThE CUTTING EDGE IN ELECTROLyTIC DETAChMENT

InZone™DetachmentSystem

Fast detachments and real-time feedback are just a click away with an advanced interface that keeps you up to speed.

backwards CompatibilityThe InZone Detachment System is capable of detaching all Boston Scientific Neurovascular coils

Single-button ActivationOne click is all it takes to begin coil detachment

Sterile Field OperationPhysician has full control with this single-use device

All photographs taken by and on file at Boston Scientific.

SySTEM READy INDICATOR

CURRENT FLOw INDICATOR

DETAChMENT bUTTON

CyCLE COMpLETE INDICATOR

GROUNDING INDICATOR

LOw bATTERy INDICATOR

Fast DetachmentsWith the InZone Detachment System, Target Coils can detach in a matter of seconds

Quick SetupNo cables, needles, or battery changes are required when used with TargetTM Detachable Coils

Ready. Set. Detached.

Direct FeedbackVisual and audio signals facilitate the detachment process through changes in position, color, and tone

PROCESSD E S I G N

QU

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TENZING™

TECHNOLOGY

Steady green light and single beep Systemreadyfordetachment

Steady green light Currentflowing,detachmentinprogress

Steady green light and three beeps Checkunderfluoro

Flashing amber light Systembatteryislow

Flashing amber light and single beep Needtogroundthesystem (Legacy Boston Scientific coils only)


pAGE 8 IbC

Confidence From Start To Finish

Selection Guide

Target Helical Ultra CoilsTargetTM 360 Standard Coils

SecondaryDiameter

(mm)

LengthinIntroducer

(cm)

ProductNumber

3mm6cm 546306

8cm 546308

4mm8cm 546408*

10cm 546410*

5mm 15cm 546515

6mm 15cm 546615

7mm15cm 546715

20cm 546720

8mm 20cm 546820

9mm20cm 546920

30cm 546930

10mm 30cm 546103

11mm 30cm 546113

12mm 30cm 546123

13mm 30cm 546133

14mm 30cm 546143

15mm 40cm 546154

SecondaryDiameter

(mm)

LengthinIntroducer

(cm)

ProductNumber

2mm

1cm 543201

2cm 543202

3cm 543203

4cm 543204

6cm 543206

2.5mm

3cm 543253

4cm 543254

6cm 543256

3mm

4cm 543304

6cm 543306

8cm 543308

4mm6cm 543406

8cm 543408

Target 360 Soft Coils

SecondaryDiameter

(mm)

LengthinIntroducer

(cm)

ProductNumber

2mm 4cm 547204

3mm6cm 547306

8cm 547308*

4mm

6cm 547406

8cm 547408

10cm 547410*

5mm10cm 547510*

15cm 547515*

6mm10cm 547610

15cm 547615*

7mm15cm 547715

20cm 547720*

8mm 20cm 547820

9mm20cm 547920

30cm 547930*

10mm 30cm 547103*

11mm 30cm 547113*

12mm 30cm 547123*

13mm 30cm 547133*

14mm 30cm 547143*

SecondaryDiameter

(mm)

LengthinIntroducer

(cm)

ProductNumber

2mm3cm 542203

4cm 542204

2.5mm 4cm 542254

3mm

4cm 542304

6cm 542306

8cm 542308

4mm

6cm 542406

8cm 542408

10cm 542410

5mm 10cm 542510

Target 360 Ultra Coils NEW

* Indicates longer coil lengths than their GDC® Detachable Coil counterparts.

Description ProductNumber

InZone™ Detachment System

451009-4

IZDS™

Connecting Cable451102-5

Target Detachable Coil Accessories

target™ Detachable Coil

See package insert for complete indications, contraindications, warnings and instructions for use.

INDICAtIONS FOr USE:Target Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Target Coils are indicated for endovascular embolization of:• Intracranial aneurysms.

• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

• Arterial and venous embolizations in the peripheral vasculature.

CONtrAINDICAtIONS:None known.

pOtENtIAl ADvErSE EvENtS:Potential complications include, but are not limited to: Aneurysm perforation and rupture, arrhythmia, death, edema, embolus, headache, hemorrhage, infection, ischemia, neurological/intracranial sequelae, post-embolization syndrome (fever, increased white blood cell count, discomfort), TIA/stroke, vasospasm, vessel occlusion or closure, vessel perforation, dissection, trauma or damage, vessel rupture, vessel thrombosis and other procedural complications including but not limited to anesthetic and contrast media risks, hypotension, hypertension and access site complications. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Please notify your Boston Scientific representative immediately if a device malfunctions or patient complication or injury is experienced or suspected associated with the use of this device. Please make every attempt to retain any suspect device, its associated components and their packaging for return to Boston Scientific.

wArNINGS:• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use

if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.

• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

• This device should only be used by physicians who have received appropriate training in interventional neuroradiology or interventional radiology and preclinical training on the use of this device as established by Boston Scientific.

• Patients with hypersensitivity to 316LVM stainless steel may suffer an allergic reaction to this implant.

• MR temperature testing was not conducted in peripheral vasculature, arteriovenous malformations or fistulae models.

• The safety and performance characteristics of the Target Detachable Coil System (Target Coils, InZone™ Detachment Systems, delivery systems and accessories) have not been demonstrated with other manufacturer’s devices (whether coils, coil delivery devices, coil detachment systems, catheters, guidewires and/or other accessories). Due to the potential incompatibility of non Boston Scientific devices with the Target Coil System, the use of other manufacturer’s device(s) with the Target Coil System is not recommended.

• To reduce risk of coil migration, the diameter of the first and second coil should never be less than the width of the ostium.

• In order to achieve optimal performance of the Target Detachable Coil System and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters and c) the 2-tip microcatheter and Boston Scientific guidewire and delivery wire. Continuous flush also reduces the potential for thrombus formation on, and crystallization of

infusate around, the detachment zone of the Target Detachable Coil.

• Do not use the product after the “Use By” date specified on the package.

• Reuse of the flush port/dispenser coil or use with any coil other than the original coil may result in contamination of or damage to, the coil.

• Damaged delivery wires may cause detachment failures, vessel injury or unpredictable distal tip response during coil deployment. If a delivery wire is damaged at any point during the procedure, do not attempt to straighten or otherwise repair it. Do not proceed with deployment or detachment. Remove the entire coil and replace with undamaged product.

• Utilization of damaged coils may affect coil delivery to, and stability inside, the vessel or aneurysm, possibly resulting in coil migration and/or stretching.

• The fluoro-saver marker is designed for use with a Rotating Hemostatic Valve (RHV). If used without an RHV, the distal end of the coil may be beyond the alignment marker when the fluoro-saver marker reaches the microcatheter hub.

• If the fluoro-saver marker is not visible, do not advance the coil without fluoroscopy.

• Do not rotate delivery wire during or after delivery of the coil. Rotating the Target Coil delivery wire may result in a stretched coil or premature detachment of the coil from the delivery wire, which could result in coil migration.

• Verify there is no coil loop protrusion into the parent vessel after coil placement and prior to coil detachment. Coil loop protrusion after coil placement may result in thromboembolic events if the coil is detached.

• Verify there is no movement of the coil after coil placement and prior to coil detachment. Movement of the coil after coil placement may indicate that the coil could migrate once it is detached.

• Failure to properly close the RHV compression fitting over the delivery wire before attaching the InZone Detachment System could result in coil movement, aneurysm rupture or vessel perforation.

• Verify repeatedly that the distal shaft of the catheter is not under stress before detaching the Target Detachable Coil. Axial compression or tension forces could be stored in the 2-tip microcatheter causing the tip to move during coil delivery. Microcatheter tip movement could cause the aneurysm or vessel to rupture.

• Advancing the delivery wire beyond the microcatheter tip once the coil has been detached involves risk of aneurysm or vessel perforation.

• 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.

CAUtIONS:• Federal Law (USA) restricts this device to sale by or on the order of a physician.

• Besides the number of InZone Detachment System units needed to complete the case, there must be an extra InZone Detachment System unit as back up.

• Removing the delivery wire without grasping the introducer sheath may result in the delivery wire and detachable coil sliding out of the introducer sheath.

• Failure to remove the introducer sheath after inserting the delivery wire into the RHV of the microcatheter will interrupt normal infusion of flush solution and allow back flow of blood into the microcatheter.

• Some low level overhead light near or adjacent to the patient is required to visualize the fluoro-saver marker; monitor light alone will not allow sufficient visualization of the fluoro-saver marker.

• Advance and retract the Target Detachable Coil carefully and smoothly without excessive force. If unusual friction is noticed, slowly withdraw the Target Coil and examine for damage. If damage is present, remove and use a new Target Coil. If friction or resistance is still noted, carefully remove the Target Coil and microcatheter and examine the microcatheter for damage.

• If it is necessary to reposition the Target Coil, verify under fluoroscopy that the coil moves with a one-to-one motion. If the coil does not move with a one-to-one motion or movement is difficult, the coil may have stretched and could possibly migrate or break. Gently remove both the coil and microcatheter and replace with new devices.

• Increased detachment times may occur when:

- Other embolic agents are present. - Delivery wire and microcatheter markers are not properly aligned. - Thrombus is present on the coil detachment zone.

• Do not use detachment systems other than the InZone Detachment System.

Page 1© medicalvision

16. Sep.2009 Date:Project:Client:

Target Helical several

L06_Target Helical with Primary Wire OD, Primary Coil OD and Secondary OD

blue sphere left from red line

Length in Introducer (cm)

SecondaryDiameter (mm)

100%

Length in Introducer (cm)

Secondary Diameter (mm)

2D DistalLoop (mm)

75%

100%


Delivering what’s next.™

NeurovascularBostonScientificCorporation47900BaysideParkwayFremont,CA94538-6515www.bostonscientific.com/neuro

To order product or for moreinformation, contact customerservice at1.888.272.1001

©2010BostonScientificCorporation

oritsaffiliates.Allrightsreserved.

90542785-01

90542785.AB

InZone™ Detachment System

See package insert for complete indications, contraindications, warnings and instructions for use.

INDICAtIONS FOr USE:The InZone Detachment System is intended for use with all versions of Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

CONtrAINDICAtIONS:None known.

pOtENtIAl ADvErSE EvENtS:No adverse events are associated with the use of the InZone Detachment System as a stand alone device. Refer to Boston Scientific Detachable Coil Directions for Use for adverse events associated with the use of Boston Scientific detachable coils. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Please notify your Boston Scientific representative immediately if a device malfunctions or patient complication or injury is experienced or suspected associated with the use of this device. Please make every attempt to retain any suspect device, its associated components and their packaging for return to Boston Scientific.

wArNINGS:• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use

if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.

• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• This device should only be used by physicians who have received appropriate training in interventional neuroradiology or interventional radiology and preclinical training on the use of this device as established by Boston Scientific.

• The InZone Detachment System can only be used with Boston Scientific detachable coils (Target™ Detachable Coil, GDC® Detachable Coil and Matrix2® Detachable Coil) and the IZDS™ Connecting Cable. DO NOT SUBSTITUTE any components or devices from other manufacturers or injury to the patient or user could result.

• Advancing the coil delivery wire beyond the microcatheter tip once the coil has detached may increase the risk of aneurysm or vessel rupture.

• Sliding the detachment system with too much force or failing to tighten the microcatheter RHV prior to detachment may cause the delivery wire to kink or result in displacement of the coil and/or microcatheter tip in the vessel, which could lead to failed detachment, suboptimal coil position post-detachment, vessel perforation, aneurysm perforation, pseudoaneurysm and aneurysm rupture. Do not advance the InZone Detachment System over the coil delivery wire against significant resistance.

• After use, the InZone Detachment System (excluding packaging) should be handled and processed as biohazardous material. After use, dispose of the InZone Detachment System unit in accordance with hospital, administrative and/or local government policy for the handling, processing and disposal of biohazardous materials. Dispose of packaging, delivery wires, introducer sheaths, IZDS Connecting Cable (UPN M00345110250, if applicable) and needle (if applicable) in accordance with hospital, administrative and/or local government policy.

CAUtIONS:• Federal Law (USA) restricts this device to sale by or on the order of a physician.

• Prior to beginning a procedure, confirm that there are enough detachment systems on the shelf to complete the anticipated number of detachments required. In addition, one extra InZone Detachment System is required as backup for all procedures. Verify that the InZone Detachment Systems to be used are within their indicated shelf life.

• One extra IZDS Connecting Cable (UPN M00345110250) and sterile 20- or 22-gauge uncoated stainless steel hypodermic needle are required as backup for all procedures using the InZone Detachment System to detach GDC or Matrix2 Detachable Coils. Verify that the cables and needles to be used are within their indicated shelf life.

• While it is essential to sufficiently tighten the microcatheter RHV around the coil delivery wire prior to using the InZone Detachment System, over-tightening the RHV could cause the delivery wire to kink.

• Batteries are pre-loaded into the InZone Detachment System. Do not attempt to replace batteries or open the enclosure.

• Increased detachment times may occur when:

• Other embolic agents are present.

• Delivery wire and microcatheter markers are not properly aligned.

• Thrombus is present on the coil detachment zone.

• The IZDS Connecting Cable has been resterilized. The IZDS Connecting Cable is supplied for one use only and should be discarded after each procedure (Only applicable when detaching GDC or Matrix2 Detachable Coils).

• If device is set down, take care to gently place it in a stable position so that it does not slide off of the delivery wire during detachment. If device is held, take care to gently hold it in a stable position so that it does not slide off of the delivery wire during detachment.

• In some ECG equipment, perturbations may be observed immediately before illumination of the DETACHMENT DETECTION indicator on the InZone Detachment System.

• Because coils are not always detached following completion of a cycle, ALWAYS verify under fluoroscopy that the coil has detached by slowly pulling back on the delivery wire while monitoring the fluoro image to make sure there is no movement of the coil. In the unlikely event the coil moves (indicating it is still attached to the delivery wire), check and adjust the flush system, check and adjust the grounding setup (only applicable when detaching GDC or Matrix2 Detachable Coils), realign the delivery wire with the microcatheter, tighten the RHV and repeat the detachment procedure.

• Needle must not be coated.

• If the patient experiences pain at the site of the needle, or if detachment times are increasing, replace the needle with a new needle at a new insertion site.

• The IZDS Connecting Cable is intended for single patient use only. Do not resterilize and/or reuse. Resterilization could corrode the connecting cable, resulting in increased detachment times.

• Disconnection or poor connection of any part of the grounding setup after the detachment system indicates SYSTEM READY may result in an inability to detach GDC or Matrix2 Detachable Coils.

• The safety and performance characteristics of the InZone Detachment System when used with another manufacturer’s devices (whether coils, coil delivery devices, catheters, guidewires and/or other accessories), have NOT been established. Due to the potential incompatibility of non-Boston Scientific components with the InZone Detachment System, the use of another manufacturer’s device(s) with the InZone Detachment System is not recommended.


Documents

Target Detachable Coils - AngioCalc · ta™ngibn Advan Advv Advdan Glass model results may not necessarily be indicative of clinical performance. All photographs taken by and on