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

ENGLISH
Embosphere® Microspheres in a Prefilled Syringe - For Embolization
CAUTION: Federal (U.S.A.) law restricts this device to
use by or on the order of a licensed physician.
INTENDED USE:
Embosphere Microspheres are indicated for use in embolization
of arteriovenous malformations, hypervascular tumors, and
symptomatic uterine fibroids.
CLINICAL APPLICATIONS FOR UTERINE FIBROIDS:
Uterine fibroid embolization (UFE) is an alternative treatment for
women requiring treatment for relief of symptoms attributed to
uterine fibroids, including heavy menstrual bleeding, pelvic pain
or pressure, and/or urinary dysfunction.
DEVICE DESCRIPTION:
Embosphere Microspheres are part of a family of embolic materials
based on Merit Medical’s proprietary microsphere technology.
These spheres are designed to offer controlled, targeted
embolization.
Embosphere Microspheres are biocompatible, hydrophilic, non-
resorbable, microspheres produced from an acrylic polymer and
impregnated with porcine gelatin. Embosphere Microspheres are
available in a range of calibrated sphere sizes.
DEVICE PACKAGING:
• Embosphere Microspheres are contained in a sterile, 20 cc pre-
filled syringe, packaged in a peel-away pouch.
• Each syringe contains approximately 1.0 mL or 2.0 mL
of Embosphere Microspheres in pyrogen-free, sterile,
physiological saline.
The following contraindications, warnings, precautions, and
instructions for use are organized to present information
applicable to all indications (i.e., hypervascular tumors,
arteriovenous malformations, and uterine fibroids) first, followed
by indication-specific information (i.e., UFE and neurological).
CONTRAINDICATIONS:
All indications
• 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 collateral vessel pathways potentially endangering
normal territories during embolization
• Presence of arteries supplying the lesion not large enough to
accept Embosphere Microspheres
• Vascular resistance peripheral to the feeding arteries precluding
passage of Embosphere Microspheres 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
UFE Specific Contraindications
• Pregnant women
• Suspected pelvic inflammatory disease or any other active
pelvic infection
• Any malignancy of the pelvic region
• Endometrial neoplasia or hyperplasia
• Presence of one or more submucosal fibroid(s) with more than
50% growth into the uterine cavity
• Presence of pedunculated serosal fibroid as the dominant
fibroid(s)
• Fibroids with significant collateral feeding by vessels other than
the uterine arteries
Neurological Specific Contraindications
• Presence of patent extra-to-intracranial anastomoses or shunts
• Presence of end arteries leading directly to cranial nerves
• In any vasculature where Embosphere Microspheres could
pass directly into the internal carotid artery, vertebral artery,
intracranial vasculature or the above listed vessels
WARNINGS:
All Indications
• Embosphere 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 Embosphere 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 Embosphere Microspheres
when embolizing arteriovenous malformations with large
shunts to avoid passage of the spheres into the pulmonary or
coronary circulation.
• Some of the Embosphere Microspheres may be slightly outside
of the range, so the physician should be sure to carefully
select the size of Embosphere 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. Embosphere 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.
• 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 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.
• Consider upsizing the microspheres if angiographic evidence of
embolization does not quickly appear evident during injection
of the microspheres.
UFE Specific Warnings
Warnings about UFE and Pregnancy
• The effects of UFE on the ability to become pregnant and carry
a fetus to term, and on the development of the fetus, have not
been determined. Therefore, this procedure should only be
performed on women who do not intend future pregnancy.
• Women who become pregnant following UFE may be at
increased risk for postpartum hemorrhage, preterm delivery,
cesarean delivery, and malpresentation.
• Devascularization of the uterine myometrium resulting from
UFE may theoretically put women who become pregnant
following UFE at increased risk of uterine rupture.
Other UFE Warnings
• When using Embosphere Microspheres for uterine fibroid
embolization, do not use microspheres smaller than 500
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