Johnson & Johnson Codman ORBIT GALAXY Bedienungsanleitung Seite 2

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
ORBIT GALAXY™ Detachable Coil System
Fill ORBIT GALAXY Detachable Coil
Frame ORBIT GALAXY Detachable Coil
Description
The ORBIT GALAXY Detachable Coil System consists of a delivery system
(delivery tube and coil introducer) and a stretch resistant embolic coil. The delivery tube
is the body of the device and functions as a guidewire and a mini infusion catheter.
The coil introducer is designed to protect the coil in the packaging dispenser and
to provide support for introducing the coil into the infusion catheter. The coil is the
implantable segment of the device. See Figure 1. It integrates a stretch resistant polymer
monofilament through the inner diameter of the coil. The system is designed for use under
fluoroscopy with a .014" or .018" (0.35 mm or 0.46 mm) guidewire compatible infusion
catheter, 59.05 in (150 cm) long, dual marker band such as PROWLER
® ®
SELECT LP ES, PROWLER Plus, PROWLER
Compatibility with other infusion catheters has not been established.
®
The TRUFILL DCS Syringe II (sold separately) is required to properly purge and detach
the coil. See syringe instructions for use. The coil is detached from the delivery tube by
a proprietary hydraulic release mechanism.
The ORBIT GALAXY Detachable Coil System is packaged inside a protective dispenser tube.
The product is held in place by means of a hub-to-dispenser tube clip. The entire system
is packaged inside a sealed protective pouch. A luer valve is provided with the system if
the user prefers to remove the syringe from the hub of the delivery tube after purging and prior
to detaching the coil. The luer valve is attached to the packaging dispenser with a clip.
Indications
The Fill ORBIT GALAXY Detachable Coil and the Frame ORBIT GALAXY Detachable Coil
are indicated for embolizing intracranial aneurysms and other vascular malformations such
as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The Fill ORBIT GALAXY Detachable Coil and the Frame ORBIT GALAXY Detachable Coil
are also intended for arterial and venous embolization in the peripheral vasculature.
Contraindications
Use of the system is contraindicated when:
• superselective placement is not possible
• the arteries supplying the lesion are not large enough to accept embolic material
• patent extra-to-intracranial anastomoses are present
• end arteries lead directly to cranial nerves
• the A-V shunt is bigger than the size of the coil
• there is severe atheromatous disease
• in the presence or likely onset of vasospasm
Magnetic Resonance Imaging (MRI) Information
Non- clinical testing demonstrated that the detachable coil is MR Conditional. A patient with
this device can be scanned safely, immediately after implant, under the following conditions:
Static Magnetic Field
• static magnetic field of 3 Tesla or less
• maximum spatial gradient magnetic field of 720 Gauss/cm or less
206598-001-B.indd 2 206598-001-B.indd 2
® ®
14, PROWLER
® ® ®
SELECT Plus, and RAPIDTRANSIT .
MRI- Related Heating
In non-clinical testing, the coil produced a temperature rise of +1.8 degrees centigrade
during MRI performed for 15 minutes of scanning in a 3 Tesla MR system. Therefore, the
MRI-related heating experiments for the detachable coil at 3 Tesla using a transmit/receive
RF body coil at an MR system reported whole-body-averaged specific absorption rate
(SAR) of 2.9-W/kg indicated that the greatest amount of heating that occurred in association
with these specific conditions was equal to or less than +1.8 degrees centigrade.
MR image quality can be compromised if the area of interest is in the same area or
relatively close to the position of the detachable coil. Optimization of MR imaging
parameters is recommended.
WARNINGS
• Perform the procedure under the direction of personnel with interventional training
and thorough knowledge of coil embolization techniques. Appropriate facilities must
be available for managing potential complications of the procedure.
• Avoid introduction of contaminants as these can cause foreign body reactions or infection.
• Incomplete occlusion can give rise to hemorrhage, ischemia, infarction, development
of alternative vascular pathways, or recurrence of symptoms.
• Use only the TRUFILL DCS Syringe II with this device.
• The introduction of air emboli can occur during detachment if any of the following is not
performed properly:
saline purge of the syringe to remove all air prior to connecting to the delivery tube hub
o
saline purge of the delivery tube with visual confirmation at the hub
o
saline flush of the delivery tube hub prior to any system reconnections
o
• Do not use the distal tip of the infusion catheter to manipulate or reposition coils previously
detached in the patient's vasculature.
• Keep the system within the intravascular space. Long term effects on extravascular tissue
have not been established.
• Failure to open the second rotating hemostasis valve (RHV) sufficiently prior to slow and
careful removal of the delivery tube from the patient could result in damage to the distal
portion of the delivery tube.
Precautions
• Inspect the sterile package carefully. Do not use if:
the package or seal appears damaged,
o
contents appear damaged, or
o
the expiry date has passed.
o
• This device is for single use only. Do not reuse. Discard after one procedure.
• Use aseptic technique in all phases of handling this product.
• The detachable coils are delicate and must be handled carefully. Prior to use and when
possible during the procedure, inspect the system for bends or kinks. Do not use a coil
system showing signs of damage.
• Do not expose the system to organic solvents.
• Multiple embolization procedures can be required to achieve the desired occlusion of some
vessels or aneurysms.
• Store in a cool, dark, dry place.
• Angiography is necessary for pre-embolization evaluation, operative control, and post-
embolization follow up.
• Ensure proper detachable coil selection according to vascular territory and measurements
taken from a baseline angiogram.
Adverse Events
Complications specific to embolization procedures can occur at any time during or after the
procedure and can include, but are not limited to, the following:
• ischemia at an undesired location
• stroke or cerebral infarction
• coil migration into normal vessels adjacent to the lesion
• pulmonary embolism
• vessel dissection, perforation, rupture and hemorrhage
• neurological deficits
• injury to normal vessels or tissue
• infection
• allergic reaction
• vasospasm
• death
2
5/21/2010 4:57:10 PM 5/21/2010 4:57:10 PM