Bard Stinger Gebrauchsinformationen Seite 5

Acute and Long-Term Effectiveness
Of the 247 patients treated with the Stinger* Ablation Catheter, acute
success was achieved in 230 patients (93%). There were a total of
17 acute failures of which 12 procedures were completed with a non-
protocol device, no energy was delivered in 4 procedures due to RF
generator malfunction, and the study device was not used in 1 patient
due to the patient's tortuous anatomy.
Success Results for Specific Arrhythmias
Acute Success
Long-Term Success at
3 Months 219/226**
Table entries show % (number success/number evaluated)
* Exact 95% confidence intervals (CI) based on the binominal distribution
** Four (4) patients not evaluated for long-term success due to 1 death and 3
lost to follow-up prior to 3 months.
Antiarrhythmic Medications: For this study, a medication was
considered antiarrhythmic if it was given specifically for treatment of
the patient's arrhythmia.
Antiarrhythmic Medications
All
Accessory Pathways
AVNRT
AV Node
>1 Type
7. PATIENT TREATMENT
7.1 Pre-Procedure and Post-Procedure
The patient should be prepped for the ablation according to the
standard practice at the clinical site, for example:
a) discontinue antiarrhythmic drugs at least 5 half-lives prior to the
ablation procedure,
b) anticoagulation therapy such as heparin, and
c) a baseline electrophysiological study documenting the presence
of the arrhythmia.
7.2 Choosing Temperature or Power Control Mode
Please refer to the Directions for Use of a compatible RF generator
for information in choosing between temperature or power control
modes.
7.3 Specific Patient Populations
The safety and effectiveness of the Stinger* Ablation Catheter has not
been studied in:
* Asymptomatic patients; and
* Patients who are pregnant.
8. PATIENT COUNSELING INFORMATION
Patients may require anticoagulation and/or antiplatelet therapy for an
indefinite period based on the patient's condition.
9. HOW SUPPLIED
The Stinger*/Stinger* M/Stinger* S/Stinger* SM Ablation Catheter is
provided sterile (EO). The device is a 7F catheter shaft with a usable
length of 85 +2/-5cm or 115 +2/-5cm, and the following features:
Curve Types:
Number of Electrodes:
Tip Electrode:
Connector Type:
Spacing:
Total* Accessory AVNRT
Pathway Node Type
93% 88% 95%
230/247 43/49 151/159
CI: 89%
96%
97% 93% 97%
38/41 146/150
CI: 95%
99%
% of Patients % of Patients
Prior to Ablation @ 3 Months
68% (156/230) 11% (25/226)
53% (23/43) 5%
68% (102/151) 7% (11/150)
88% (28/32) 39% (12/31)
75% (3/4) 0%
A, B, C, D, E, F & G
4
7Fx 4mm / 8Fx 5mm
10 Pin
2mm/5mm/2mm
Following is a diagram of the Stinger*/Stinger* M/Stinger* S/
Stinger* SM Ablation Catheter.
BI-DIRECTIONAL
DEFLECTING
9.1 Packaging
AV >1
The Stinger*/Stinger* M/Stinger* S/Stinger* SM Ablation Catheter is
supplied STERILE. The tip of the catheter is secured in a protective
tube to keep it straight. The catheter is positioned in a PVC tray with
91% 100%
a PVC lid holding it in the tray. The tray with lid is placed in a pouch
32/35 4/4
and sealed. The sealed pouch is placed in a folding carton. Both the
pouch and the folding carton are labeled sterile unless the package is
damaged or open.
100% 100%
9.2 Storage
31/31 4/4
The Stinger*/Stinger* M/Stinger* S/ Stinger* SM Ablation Catheter
must be stored in a cool, dry place. Storage temperature should be
between 0° and 45°C.
9.3 Shelf-Life
The Stinger*/Stinger* S/Stinger* M/Stinger* SM Ablation Catheter has
an expiration date of three (3) years.
10. DIRECTIONS FOR USE
10.1 Physician Training
Physicians must be familiar with the techniques and appropriately
trained for cardiac mapping and ablation procedures. All mapping
and ablation procedures must be performed in a fully-equipped
electrophysiology laboratory.
10.2 Compatible RF Generator and Accessories
The Stinger*/Stinger* M/Stinger* S/Stinger* SM Ablation Catheter
should be used only with a legally marketed RF generator which has
been shown to be safe and effective for cardiac ablation. The
(2/41)
Stinger*/Stinger* M/Stinger* S/Stinger* SM Ablation Catheter is to be
used with the appropriate Bard TempLink*/TempLink* M Extension
Cable.
Specifications for Compatible RF Generators:
(0/4)
Generator
Thermometry
Temperature Limit, Maximum
Modes:
(must operate in all 3 modes)
Maximum Output Power
RF Output Frequency
Impedance Cut-off
Refer to the manufacturer's manual for detailed generator operating
instructions for RF catheter ablation with a compatible generator.
Accessories
The Bard Electrophysiology TempLink* Extension Cable was
designed for use with the Stinger* /Stinger* S Ablation Catheter.
The Bard Electrophysiology TempLink* M Extension Cable was
designed for use with the Stinger* M/Stinger* SM Ablation Catheter.
10.3 Handling and Preparation
Prior to use, inspect the packaging. Do not use if open or damaged.
Using aseptic technique, remove the catheter from its package and
place it in a sterile working area. Inspect the catheter carefully for
electrode integrity and overall condition.
PK5014758 / Rev. 11 / Page 5
TIP
SHAFT
85 - 115 CM
Stinger*/TempLink* --
Stinger* S/TempLink *
With thermistor temperature sensor
Stinger*M/TempLink* M --
Stinger* SM/TempLink* M --
With thermocouple temperature
sensor
95°C
Temperature Control
Temperature Monitoring
Power Control
50 W (Stinger* M & Stinger* SM)
70 W (Stinger* & Stinger* S)
450kHz - 550kHz
High: 300 ohms
HANDLE
CONNECTOR
SLIDE
MECHANISM
Specification
Low: 50 Ohms