Intended Use; Contraindications - BioSphere Medical HepaSphere Instructions D'utilisation

ENGLISH

INTENDED USE

HepaSphere™ Microspheres are indicated for use in embolization
of blood vessels 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. 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 in 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 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 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.
• Because of the significant complications of misembolization,
Dry (µm)
50-100
100-150
150-200
extreme caution should be used for any procedures above the 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
(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.
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. Contamination of the device
may lead to injury, illness or death of the patient. All procedures
must be performed according to accepted aseptic technique.
HepaSphere Microspheres MUST NOT be used in their original
dry state. They 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 injected easily through
microcatheters. However, injection of the HepaSphere
Microspheres before they are fully expanded could result in failure
to reach the intended embolization target and possible embolization
of a larger tissue area.
Patients with known allergies to non-ionic contrast media may
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