Merit Medical EmboGold Microspheres Prefilled Syringe IFU-US - Manual (Page 3)

ENGLISH
CAUTION: Federal (U.S.A.) law restricts this device to use by
or on the order of a licensed physician.
INTENDED USE :
• Embolization of hypervascularized tumors.
• Embolization of arteriovenous malformations (AVM).
CLINICAL APPLICATIONS :
Scientific literature provides extensive documentation of
embolization procedures using a wide variety of agents in both the
neurological and peripheral circulatory systems, including the head,
neck, spine, liver, genitourinary tract, uterus, gastrointestinal
system, limbs, and lungs. A representative bibliography of this
literature is provided following these instructions for use.
DESCRIPTION :
EmboGold Microspheres are part of a family of new embolic
materials based on BioSphere Medical’s proprietary microsphere
technology. These colored spheres are designed to add easy
visualization during handling, while still offering the controlled,
targeted embolization characteristics of the first microsphere
product, Embosphere® Microspheres.
EmboGold Microspheres are biocompatible, hydrophilic, non-
resorbable, precisely calibrated microspheres produced from an
acrylic polymer and impregnated with porcine gelatin. EmboGold
Microspheres are available in a range of sizes.
DEVICE PACKAGING :
• Embolic contained in sterile, 20 mL syringe (pre-filled syringe),
packaged in a peel-away tray.
• Each syringe contains approximately 1.0 mL or 2.0 mL of
EmboGold Microspheres in pyrogen-free, sterile, physiological
saline.
CONTRAINDICATIONS :
• Patients intolerant to occlusion procedures
• Vascular anatomy or blood flow that precludes catheter
placement or embolic agent injection.
• Presence or likely onset of vasospasm.
• Presence or likely onset of hemorrhage.
• Presence of severe atheromatous disease.
• Presence of feeding arteries smaller than distal branches from
which they emerge.
• Presence of patent extra-to-intracranial anastomoses or shunts.
• Presence of collateral vessel pathways potentially endangering
normal territories during embolization.
• Presence of end arteries leading directly to cranial nerves.
• Presence of arteries supplying the lesion not large enough to
accept EmboGold Microspheres.
• Vascular resistance peripheral to the feeding arteries precluding
passage of EmboGold Microspheres into the lesion.
• Do not use EmboGold Microspheres in the following applications:
a. Embolization of 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).
b. In the pulmonary arterial vasculature.
c. Use in any vasculature where EmboGold Microspheres could
pass directly into the internal carotid artery, vertebral artery,
intracranial vasculature or the above-listed vessels.
• Patients who have an allergic response to gold.
WARNINGS:
• EmboGold Microspheres contain 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 stabilizers.
• Studies have shown that EmboGold Microspheres do not form
aggregates, and as a result, penetrate deeper into the vasculature
as compared to similarly sized PVA particles. Care must be taken
to choose larger sized EmboGold Microspheres when embolizing
arteriovenous malformations with large shunts to avoid passage
of the spheres into the pulmonary or coronary circulation.
• Some of the EmboGold Microspheres may be slightly outside of
the range, so the physician should be sure to carefully select the
size of EmboGold 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.
EmboGold Microspheres size should be selected to prevent
passage from artery to vein.
• 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.
• The color of the EmboGold Microspheres could be visible through
the skin if injected into arteries feeding superficial tissues.
• 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.
• EmboGold Microspheres are not cleared for use in uterine fibroid
embolization and are associated with delayed pain and/or rash
when used in these procedures.
• Pay careful attention for signs of mistargeted 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
microsphere size if any signs of mistargeting occur or patient
symptoms develop.
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EmboGold ® Microspheres in a Prefilled Syringe - For Embolization