Steroid-Eluting Pace/Sense and Defibrillation Silicon Lead with Lubricious Coating Extendable/Retractable Helix
0184/0185/0186/0187 0180/0181
MRI



0184/0185/0186/0187 ENDOTAK

ENDOTAK
ICD Y
0184/0185/0186/0187 ENDOTAK

ENDOTAK
ICD Y
MRI (MR
Conditional System Information)
MRI


MRI
MRI
4
MRI
0184/0185/0186/0187 ENDOTAK
D
0184/0185/0186/0187 ENDOTAK
D
3. www.bostonscientific-elabeling.com
American College of
MR Practices5 Zone III
MRI
Zone III IV


Roentgenology 188:1447-74, 2007.
Guide)

RELIANCE SG
RELIANCE SG
MRI
MRI
MRI


Precautions................................................................. 4 Potential Adverse Events...................... 5
Warranty...................................................................... 5
LEAD FEATURES.........................................................................6
Handling the Lead.................................... 13
IMPLANTATION.........................................................................................14 Inserting the Stylet................................... 14 Handling the Fixation Helix............... 14 Inserting the Lead.............................................. 15 Positioning the Lead................................... 18 Lead Fixation..................................................... 19 Checking for Lead Stability.......... 21 Repositioning the Lead........................... 21
Evaluating Lead Position............................ 21 Minimizing Pacemaker Interaction........................................ 22 Taking Baseline Measurements........................... 22
Electrical Performance.......................................... 23 Evaluating with the Device..................... 23 ECD Evaluating with the ECD....................... 24
Conversion Testing........................................ 24 Securing the Lead............................................. 26 Percutaneous Implant Technique.............. 26 Venous Cut-Down Technique........................... 26
(Abdominal Implants)Model 0187................. 28 Tunneling the Lead to the Abdominal Pocket....................... 28 Connection to the Device.................................. 29
POST-IMPLANT EVALUATION......................................29 Explantation...................................................................... 30
SPECIFICATIONSNominal...............................................................31

ENDOTAK RELIANCE G/SG DEVICE DESCRIPTION
1
VENTAK® ECDENDOTAK SQ ARRAY ENDOTAK SQ ARRAYICD Y ICD Y
Indications for Use ENDOTAK RELIANCE GModel 0184/0185/0186/0187 ENDOTAK RELIANCE SG Model 0180/0181 ICD/CRT-D
Contraindications



1. GOREW. L. Gore and Associates 2. DF-1 ISO 11318:1993 3. IS-1 ISO 5841-3:1992
ENDOTAK RELIANCE G/SG DEVICE DESCRIPTION
2
Warnings
ICD/CRT-D Lead Compatibility ENDOTAK ICD/ CRT-D
MRI MRI Exposure
(Diathermy Exposure)

ICD/CRT-D 19
ENDOTAK RELIANCE G/SG DEVICE DESCRIPTION
3
Conversion Testing ENDOTAK 24
ENDOTAK RELIANCE G/SG DEVICE DESCRIPTION
4
Other







ENDOTAK RELIANCE G/SG DEVICE DESCRIPTION
5
Warranty

Air embolism Allergic reaction Bleeding Cardiac perforation/tamponade Chronic nerve damage Death Elevated thresholds Erosion/extrusion Excessive fibrotic tissue growth Formation of hematomas or cysts Inappropriate therapy/shocks Incomplete connection with pulse generator Infection Keloid formation Lead abrasion Lead displacement/dislodgment Lead fracture, insulation break
Lead tip deformation and/or breakage Local tissue reaction Low amplitude VF signals Myocardial injury Myocardial irritabillity Oversensing/ undersensing Pheumothorax Post-shock rhythm disturbances Random component failures Shunting current or insulating myocardium during defibrillation with internal or external paddles Threshold elevation Thrombosis/thromboemboli Venous occlusion Venous perforation
ENDOTAK RELIANCE G/SG LEAD FEATURES
6
LEAD FEATURES ENDOTAK RELIANCE G ENDOTAK RELIANCE SG :
1.0 mg
Cathode
X X X
Anode Cathode AnodeENDOTAK RELIANCE G Anode Cathode ENDOTAK RELIANCE
GORE™ ePTFE ePTFE
ENDOTAK RELIANCE G 2 ENDOTAK RELIANCE SG 1 PTFE
ENDOTAK RELIANCE
ENDOTAK RELIANCE G/SG LEAD FEATURES
7

ENDOTAK RELIANCE G DF-1 2 IS-11ENDOTAK RELIANCE SGDF-11 IS-1 1
SVC 11

ENDOTAK RELIANCE 18 cm 1
ENDOTAK RELIANCE G 0184 0185 0186 0187 59 cm 64 cm 70 cm 90 cm
ENDOTAK RELIANCE SG 0180 0181 59 cm 64 cm
1. ENDOTAK RELIANCE
18 cm
8
ICD/CRT-D ENDO- TAK RELIANCE GENDOTAK RELIANCE SG ENDOTAK RELIANCE G/SG DFT ENDOTAK SQ ARRAY ENDOTAK RELIANCE G/SG ENDOTAK ENDOTAK SQ ARRAY
ENDOTAK RELIANCE EP

ICD ICD ENDOTAK RELIANCE ICD Minimizing Pacemaker Interaction22


ENDOTAK RELIANCE G/SG LEAD EVALUATION
9
Sterilization EO
Storage


20ºC 25ºC50ºC
Surgical Preparation ECG X
TVITransvalvular Insertion Tool: Vein Pick Lead CapsDF-1; 2IS-1; 1 DF-1 ENDOTAK RELIANCE SG 1 1
a. 0.014 in (0.36 mm) b. 0.016 in (0.41 mm)
ENDOTAK RELIANCE G/SG LEAD EVALUATION
10




ENDOTAK RELIANCE G/SG LEAD EVALUATION
11


Stylets Firm Soft 1Inserting the Stylet14
1.
2.
3.
12
TVI Transvalvular Insertion Tool TVI ENDOTAK RELIANCE G ENDOTAK RELIANCE SG TVI e-PTFE 5

TVI TVI TVI
2. TVI
3. TVI TVI TVI
Vein Pick
4.
5. TVI
13

Lead Caps 7 ICD Y
Handling the Lead



IS-1 DF-1
14
IMPLANTATION
10 12 cc 8



Lead Fixation 19 SPECIFICATIONS31
8.
15






16

5

1. 9StCp
2. StCp Ax
3. V
4. Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator leads, and failure of central venous catheters adjacent to the sternoclavicular joint. PACE. 1993;16:445-457.
5. Magney JE, et al. A new approach to percutaneous subclavian venipuncture to avoid lead fracture or central venous catheter occlusion. PACE. 1993;16:2133-2141.
ENDOTAK RELIANCE G/SG IMPLANTATION
17
5.
9.
18
10.


19

ICD/CRT-D
ICD
Lead Fixation ENDOTAK RELIANCE G ENDOTAK RELIANCE SG

1. 13
2.
12. ENDOTAK RELIANCE SG

20
SPECIFICATIONS31 X

3.
14.
21

Checking for Lead Stability 8 10 cm X

Evaluating Lead Position ECD X

ENDOTAK RELIANCE G/SG IMPLANTATION
22
ICD Tachy Mode Monitor + Therapy
EP
Taking Baseline Measurements PSA
PSA 2
6. Epstein AE, et al. Combined automatic implantable cardioverter-defibrillator and pacemaker systems: implantation techniques and follow-up. JACC. 1989;13:121-131.
7. Calkins H, et al. Clinical interactions between pacemakers and automatic implantable cardioverter-defibrillators. JACC. 1990;16:666-673.
R
23
R

Electrical Performance ECD
ECD
ECD ECDOFF ECD ECDECD
Evaluating with the Device Connection to the Device29
2. a
b. c.
ENDOTAK RELIANCE G/SG IMPLANTATION
24
ECD Evaluating with the ECD ECD
PRM ICD/CRT-D

ECD 40 J ECD ECD
(1) (2)(3)
Conversion Testing ECDVFVT ECD ECD
VF
ENDOTAK RELIANCE G/SG IMPLANTATION
25
1 2 cm
T TTWOS
VF DFTVF 1

ENDOTAK RELIANCE G ENDOTAK RELIANCE SG ENDOTAK SQ ARRAY ENDOTAK SQ ARRAY ENDOTAK RELIANCE G ENDOTAK RELIANCE SG ENDOTAK SQ ARRAY
ENDOTAK SQ ARRAY ENDOTAK SQ ARRAY
ENDOTAK
DFT CER DFT CER
VF
ECD ECD ECD OFF
ENDOTAK RELIANCE G/SG IMPLANTATION
26
2.
3.
Venous Cut-Down Technique 1. 16
15.

27
3.


16.
28

Tunneling the Lead to the Abdominal Pocket

ECD

29


pacing/sensing defibrillating DFT

POST-IMPLANT EVALUATION
R

30
ENDOTAK RELIANCE G/SG SPECIFICATIONSNominal
31

a
0180, 0181- 11 0184, 0185, 0186- 11 0187- 15

(1) IS-1 (1) DF-1
(1) IS-1 (2) DF-1
b


ENDOTAK RELIANCE G/SG SPECIFICATIONSNominal
32

0187- 2.5 Ω
(DBS)PTFE

a.X b. 10.5F (3.5 mm)
ENDOTAK RELIANCE G/SG (SYMBOLS ON PACKAGING)
33
REF
9