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EmboCube™
Embolization Gelatin
I N S T R U C T I O N S F O R U S E
Caution: Federal (U.S.A.) law restricts this device to use by or on the
order of a licensed physician.
INTENDED USE
EmboCube Embolization Gelatin is indicated for use in embolization of:
•
Hypervascular tumors,
•
Blood vessels to occlude blood flow to control bleeding / hemorrhaging in
the peripheral vasculature.
DEVICE DESCRIPTION
EmboCube Embolization Gelatin consists of biocompatible, hydrophilic and dry
pre-cut cubes of resorbable porcine gelatin packaged in a 10-mL syringe with
a standard luer lock tip.
SPECIFICATIONS
EmboCube Embolization Gelatin is sold in two sizes (2.5 mm and 5.0 mm) and
three weight configurations with the specification for each size listed below:
Order
Weight
Cube
Number
Hydrated
Size
EC2525
25 mg
2.5 mm
EC2550
50 mg
2.5 mm
EC25100
100 mg
2.5 mm
EC5025
25 mg
5.0 mm
EC5050
50 mg
5.0 mm
EC50100
100 mg
5.0 mm
Based on an animal model, EmboCube Embolization Gelatin showed signs of
resorption at week 4.
CONTRAINDICATIONS
•
Patients intolerant to occlusion procedures
•
Vascular anatomy or blood flow that precludes catheter placement or
embolic agent injection
•
Presence of vasospasm
•
Presence of severe atheromatous disease
•
Presence of feeding arteries too small to accept the selected device
•
Presence of collateral vessel pathways potentially endangering normal
territories during embolization
•
Presence of arteries supplying the lesion not large enough to accept the
EmboCube Embolization Gelatin
•
Vascular resistance peripheral to the feeding arteries precluding passage of
the EmboCube Embolization Gelatin into the lesion
•
In large diameter arteriovenous shunts (i.e. where the blood does not pass
through an arterial/capillary/venous transition but directly from an artery
to a vein)
•
In the pulmonary vasculature
•
Coronary and intracerebral vascular use
•
Presence of patent extra-to-intracranial anastomoses or shunts
•
Presence of end arteries leading directly to cranial nerves
•
In any vasculature where EmboCube Embolization Gelatin could pass directly
into the internal carotid artery, vertebral artery, intracranial vasculature or
the above listed vessels
•
Patients with known allergy to gelatin
WARNINGS
•
EmboCube Embolization Gelatin contains gelatin of porcine origin, and
therefore, could cause an immune reaction in patients who are hypersensitive
to collagen or gelatin. Careful consideration should be given prior to using
this product in patients who are suspected to be allergic to injections
containing gelatin.
Recommended
Minimum
injection syringe
catheter ID
volume
0.024"
1 mL
(0.61 mm)
0.024"
1 mL
(0.61 mm)
0.024"
1 mL
(0.61 mm)
0.040"
3 mL
(1.02 mm)
0.040"
3 mL
(1.02 mm)
0.040"
3 mL
(1.02 mm)
English
•
The physician should be sure to carefully select the size of EmboCube
Embolization Gelatin 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. Size should be selected to prevent
passage from artery to vein.
•
Because of the significant complications of non-target embolization, 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 diameter, 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. Physicians should monitor
patients that may be at risk.
•
Onset of radiation-induced injury to the patient may be delayed. Patients
should be counseled on potential radiation side effects and whom they
should contact if they show symptoms.
•
Pay careful attention for signs of non-targeted embolization. During injection
carefully monitor patient vital signs to include SaO2 (e.g. hypoxia, CNS
changes). Consider terminating the procedure, investigating for possible
shunting, or increasing EmboCube Embolization Gelatin size if any signs of
non-target embolization occur or patient symptoms develop.
•
Consider upsizing the EmboCube Embolization Gelatin if angiographic
evidence of embolization does not quickly appear evident during injection
of the EmboCube Embolization Gelatin.
•
Post embolization swelling may result in ischemia to tissue adjacent to target
area. Care must be given to avoid ischemia intolerant, nontargeted tissue
such as nervous tissue.
Color
Code
•
EmboCube Embolization Gelatin should not be used in the neurovasculature.
PRECAUTIONS
Green
•
Patients with known allergy to contrast medium may require prophylactic
treatment prior to embolization.
Green
•
Additional evaluations or precautions may be necessary in managing
Green
periprocedural care for patients with conditions such as, but not limited to:
•
Bleeding diathesis or hypercoagulative state
Red
•
Immunocompromise
•
Do not use the EmboCube Embolization Gelatin if the syringe or packaging
Red
appear damaged.
•
For single patient use only – Contents supplied sterile - Never reuse, reprocess
Red
or resterilize the contents of a syringe. 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.
•
Do not connect the 10-mL syringe with EmboCube Embolization Gelatin
directly to a microcatheter for embolic delivery.
•
The syringe is intended for embolic use only. Do not use for any other
application.
•
Select the size and quantity of EmboCube Embolization Gelatin appropriate
for the pathology to be treated.
•
Embolization with EmboCube Embolization Gelatin should only be
performed by physicians who have received appropriate interventional
embolization training in the region to be treated.
POTENTIAL COMPLICATIONS
Vascular embolization is a high-risk procedure. Complications may occur at any
time during or after the procedure, and may include, but are not limited to, the
following:
•
Paralysis resulting from non-targeted embolization or ischemic injury from
adjacent tissue edema
•
Undesirable reflux or passage of EmboCube Embolization Gelatin 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 circulations
•
Pulmonary embolism due to arterial venous shunting
•
Ischemia at an undesirable location including ischemic stroke, ischemic
infarction (including myocardial infarction), and tissue necrosis
•
Capillary bed occlusion and tissue damage
•
Vessel or lesion rupture and hemorrhage
•
Recanalization
•
Foreign body reactions necessitating medical intervention
•
Infection necessitating medical intervention
3
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