Merit Medical HepaSphere Microspheres(With Doxorubicin) IFU-Int'l - Manual (Page 3)

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ENGLISH
INTENDED USE
HepaSphere™ Microspheres are indicated for use in embolization of
blood vessels with or without delivery of doxorubicin HCl for therapeutic
or preoperative purposes in the following procedures:
• Embolization of hepatocellular carcinoma
• Embolization of metastases to the liver.
DESCRIPTION
HepaSphere Microspheres are part of a family of embolic agents based
on proprietary technologies. They are designed for controlled, targeted
embolization. The HepaSphere Microspheres can be loaded with
doxorubicin HCl and are able to release the drug locally at the
embolization site. HepaSphere Microspheres are biocompatible,
hydrophilic,
non-resorbable, expandable, and conformable
microspheres. HepaSphere Microspheres swell upon exposure to
aqueous solutions. They are available in a range of sizes.
DEVICE PACKAGING
HepaSphere Microspheres are contained in a sterile, 10 ml Cyclic Olefin
Copolymers (COC) vial, with a crimped cap, packaged in a sealed pouch.
Contents: 25 mg or 50 mg of dry HepaSphere Microspheres per vial to
be reconstituted before use.
CONTRAINDICATIONS
• Patients intolerant to vascular occlusion procedures
• Vascular anatomy or blood flow precluding correct catheter 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
HepaSphere Microspheres 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
caution should be used for any procedures involving the extracranial
circulation encompassing the head and neck, and the physician should
carefully weigh the potential benefits of using embolization against the
risks and potential 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
applied for each specific type of procedure performed.
• Onset of radiation injury to the patient may be delayed. Patients
should be counselled on potential radiation effects, what to look for and
who 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 reconstitute HepaSphere Microspheres with Lipiodol / Ethiodol.
• Pay careful attention for signs of mistargeted embolization. During
injection carefully monitor patient vital signs to include SaO
2
(e.g.
hypoxia, CNS changes). Consider terminating the procedure,
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 sized 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 embolization 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 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.
Dry (µm)
50-100
30-60
100-150
150-200
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