Medical
BioSphere
®
Instructions for use
English
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Instructions d'utilisation
Français (French)
.............................................6
Instrucciones de utilización
Español (Spanish)
...........................................9
730070003/A ID 102412
0459 - 2004
2
3
ENGLISH
INTENDED USE
HepaSphere™ Microspheres are indicated for use in embolization of
b
lood vessels for therapeutic or preoperative purposes in the following
procedures:
• Embolization of hepatocellular carcinoma
•
Embolization of metastases to the liver
DESCRIPTION
HepaSphereMicrospheres are part of a family of embolic agents based
on proprietary technologies. They are designed for controlled, targeted
embolization. HepaSphere Microspheresare biocompatible, hydrophilic,
n
on-resorbable, expandable, and conformable microspheres.
HepaSphere Microspheres swell upon exposure to aqueous solutions.
They are available in a range of sizes.
DEVICE PACKAGING
HepaSphereMicrospheres are containedin asterile, 10 ml Cyclic Olefin
Copolymers(COC) vial, witha crimped cap, packagedin a sealed pouch.
Contents:25 mg or 50 mg of dry HepaSphere Microspheres per vial to
be reconstitutedin NaCl 0.9% aqueous solution before use (or aqueous
solution of equivalent ionic concentration).
CONTRAINDICATIONS
• Patients intolerant to vascular occlusion procedures
• Vascular anatomy or blood f low precluding correct cathe ter
placement or embolic injection
• Presence or suspicion of vasospasm
• Presence or likely onset of haemorrhage
• Presence of severe atheromatous disease
• Feeding arteries too small to accept the selected HepaSphere
Microspheres
• Presence of collateral vessel pathways potentially endangering
normal territories during embolization
• High flow arteriovenous shunts or fistulae with luminal diameter
greater than the selected size of HepaSphere Microspheres
• Vascular resistance peripheral to the feeding arteries precluding
passage of HepaSphere Microspheres into the lesion
• Presence of arteries supplying the lesion not large enough to accept
HepaSphere Microspheres
• Do not use in pulmonary vasculature, coronary and central nervous
system vasculature
• Known sensitivity to poly vinyl alcohol-co-sodium acrylate
WARNINGS
• HepaSphere Microspheres size must be chosen after consideration of
the arteriovenous angiographic appearance.HepaSphere Microspheres
size should be selected to prevent passage from any artery to vein.
• Some of the HepaSphere Microspheres may be slightly outside of the
range, so the physician should be sure to carefully select the size of
HepaSphereMicrospheres according to the size of the target vessels at
the desired level of occlusion in the vasculature and after consideration
of the arteriovenous angiographic appearance.
• Because of the significant complications of misembolization,extreme
c
aution should be used for any procedures involving the extracranial
c
irculation encompassing the head and neck, and the physician should
carefully weigh the potential benefits of using embolization against the
risks andpotential complications of the procedure. These complications
can include blindness, hearing loss, loss of smell, paralysis, and death.
• Serious radiation induced skin injury may occur to the patient due to
long periods of fluoroscopic exposure, large patient, angled x-ray
projections and multiple image recording runs or radiographs. Refer to
your facility’s clinical protocol to ensure the proper radiation dose is
a
pplied for each specific type of procedure performed.
• Onset of radiation injury to the patient may be delayed. Patients
should be counselledon potential radiation effects,what to look for and
w
ho to contact if symptoms occur.
• HepaSphere Microspheres MUST NOT be reconstituted in sterile
water for injection. Reconstitution in sterile water results in extensive
swelling that renders the injection of HepaSphere Microspheres very
difficult or may prevent injection.
• Do not reconstituteHepaSphere Microspheres with Lipiodol / Ethiodol.
• Pay careful attention for signs of mistargeted embolization. During
injection carefully monitor patient vital signs to include SAO2 (e.g.
hypoxia, CNS changes). Consid er terminating the procedu re,
investigating for possible shunting, or increasing Microspheres size if
any signs of mistargeting occur or patient symptoms develop.
• Consider upsizing the Microspheres if angiographic evidence of
embolization does not quickly appear evident during injection of the
Microspheres.
Warnings about use of small microspheres
• Careful consideration should be given whenever use is contemplated
of embolic agents that are smaller in diameter than the resolution
capability of your imaging equipment. The presence of arteriovenous
anastomoses, branch vessels leading away from the target area or
emergent vessels not evident prior to embolization can lead to
mistargeted embolization and severe complications.
• Microspheres smaller than 100 microns will generally migrate distal
to anastomotic feeders and therefore are more likely to terminate
circulation to distal tissue. Greater potential of ischemic injury results
from use of smaller microspheres and consideration must be given to
the consequence of this injury prior to embolization. The potential
consequences include swelling, necrosis, paralysis, abscess and/or
stronger post-embolization syndrome.
• Post embolization swelling may result in ischemia to tissue adjacent
to target area. Care must be given to avoid ischemia of intolerant, non
targeted tissue such as nervous tissue.
PRECAUTIONS
HepaSphere Microspheres must only be used by physicians trained in
vascular emboliz ation procedures. The size and quantity of
microspheres must be carefully selected according to the lesion to be
treated and the potential presence of shunts. Only the physician can
decide the most appropriate time to stop the injection of HepaSphere
Microspheres.
Do not use if the vial,cap, or pouch appear damaged.
For single patient use only - Contents supplied sterile - Never reuse,
reprocess, or resterilize the contents of a vial that has been opened.
Reusing, reprocessing or resterilizing 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. Reusing, reprocessing or
resterilizing may also createa risk of contamination of the deviceand or
cause patientinfection or crossinfection including,but not limited to,the
Dry (µm)
50-100
30-60
100-150
150-200
4
t
ransmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the
patient.All proceduresmust be performed accordingto accepted aseptic
t
echnique.
HepaSphere Microspheres MUST NOT be used in their original
d
ry state.
T
hey must be reconstituted before use. HepaSphere
Microspheres swell in aqueous solution. The magnitude of swelling
depends on the ionic concentration of the solution. The microspheres
swell to approximately four times their diameter in 0.9% NaCl aqueous
solution and non-ionic contrast media, as compared to their initial dry
diameter. HepaSphere Microspheres are compressible and can be
i
njected easily through microcatheters. However, injection of the
HepaSphereMicrospheres before they are fully expandedcould result in
f
ailure to reach the inte nded embolization target and po ssible
embolization of a larger tissue area.
Patients with known allergies to non-ionic contrast media may require
corticosteroids prior to embolization.
Additional evaluations or precautions may be necessary in managing
periprocedural care for patients with the following conditions:
• Bleeding diathesis or hypercoagulative state
• Immunocompromise
POTENTIAL COMPLICATIONS
Vascularembolization is a high-risk procedure.Complicationsmay occur
at any time during or after the procedure, and may include, but are not
limited to, the following:
• Paralysis resulting from untargeted embolization or ischemic injury
from adjacent tissue oedema
• Undesirable reflux or passage of HepaSphere Microspheres into
normal arteries adjacent to the targeted lesion or through the lesion into
other arteries or arterial beds, such as the internal carotid artery,
pulmonary, or coronary circulation
• Pulmonary embolism due to arteriovenous shunting
• Ischemia at an undesired location, including ischemicstroke, ischemic
infarction (including myocardial infarction),and tissue necrosis
• Capillary bed occlusion and tissue damage
• Vasospasm
• Recanalisation
• Blindness, hearing loss,and loss of smell
• Foreign body reactions necessitating medical intervention
• Infection necessitatingmedical intervention
• Complications relatedto catheterization (e.g.haematoma at the site of
entry, clot formation at the tip of the catheter and subsequent
dislodgement, and nerve and/or circulatory injuries which may result in
leg injury)
• Allergic reaction to medications (e.g. analgesics)
• Allergic reaction to non-ionic contrast media or embolic material
• Vessel or lesion rupture and haemorrhage
• Death
• Additional information is found in the Warnings section
SWELLING BEHAVIOR
HepaSphere Microspheres swell during reconstitution with NaCl 0.9%
aqueous solution and non-ionic contrast media.When hydrated in 100%
NaCl 0.9% aqueoussolution or non-ionic contrastmedium, or 50% nonionic contrast and 50% NaCl 0.9% aqueous solution, HepaSphere
Microspheres swell approximately 4 times their original dry diameter in
approximately 10 minutes. For example,HepaSphere Microspheres with
a diameter of approximately 50-100 microns in their dry state will
expand to approximately 200-400 microns during reconstitution as
recommended below. Because of the inherent variability of the swelling
process, some of the HepaSphere Microspheres will be slightly outside
of this range after reconstitution, so the physician should be sure to
carefully select the size of HepaSphere Microspheres according to the
s
ize of the target vessels at the desired level of occlusion in the
vasculature and the nature of the aqueous solution.
C
ATHETER COMPATIBILITY
HepaSphere Microspheres can be injected with microcatheters with the
following specifications:
INSTRUCTIONS
HepaSphere Microspheres must be reconstitutedwith 100% NaCl 0.9%
aqueous solution or non-ionic contrast medium, or 50% non-ionic
contrast medium and 50% NaCl 0.9% aqueous solution.
• Carefully select the size of HepaSphereMicrospheres accordingto the
size of the target vessels at the desired level of occlusion in the
vasculature and the nature of the aqueous solution. See the description
of “SWELLING BEHAVIOR”.
• HepaSphere Microspheres may be present outside the vial. Therefore,
the vial must be aseptically handled away from the main sterile field.
• Ensure the compatibility of the HepaSphere Microspheres with the
intended size of catheter to be used. See the table above.
• Inspect the packaging to confirmthat it is intact. Remove the vial from
the pouch. The external surface of the vial is sterile.
PREPARATION FOR EMBOLIZATION
The approximate reconstitution time is 10 min.
• Fill a 10ml syringe with 100% NaCl 0.9% aqueous solution or nonionic contrast medium (or 50% NaCl 0.9% aqueous solution and 50%
contrast).Connect the syringe to a needleof 20 gauge diameter or larger.
• To ensure proper reconstitution of the HepaSphere Microspheres,
grasp thevial horizontallyin your fingertipsand roll the vial severaltimes.
This will transfer the dry contents of the vial to the sidewall.
Note:
Pull back onlythe flip-top cap; do not removethe crimp ring or the
stopper from the vial.
• Carefully insert the needle from the syringe through the stopperof the
vial. Continue rolling the vial in your fingertips and inject the full amount
(10ml)
of reconstitution medium into the vial, then place the vial
vertically and carefully remove the syringe with the needle attached.
Note:
The vial is hermetically closed. Proper aspiration and/or venting
techniques, as approved by the healthcare facility, may be used for
easier injection of reconstitutionmedium into vial. If aspiration of air from
the vial is performed prior to reconstitution, exercise caution not to
remove the spheres from the vial.
• To ensure a homogene ous reconstitutio n of the HepaSphere
Microspheres, gently invert the vial back and forth so that the liquid
contacts the stopper 5-10 times.
Note:
Vigorous shaking may introduce micro bubbles,which can cause
the microspheres to aggregate.
• Wait a minimum of 10 minutes
to allow the HepaSphereMicrospheres
to reconstitute and expand fully.
• Use a 30ml syringe and 20 gauge or larger needle to aspirate the
contents of the vial. Rotate the vial to a vertical position with the bottom
of the vial facing upward.Pull the needle back so that it is submerged in
the liquid but not occluded by the stopper. Gently aspirate the entire
contents of the vial into the syringe.
Dry (µm)
Approximate
R
econstituted
Size range (µm)
C
atheter Size ID
(in.)
30-60 120 - 240
≥ 0.021
50-100 200 - 400
≥
0.021
1
00-150400 - 600
≥ 0.024
150-200 600 - 800
≥ 0.027
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