Merit Medical Embosphere Microspheres Sterile Vial IFU-US - Manual (Page 2)

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ENGLISH Embosphere
®
Microspheres in a Sterile Vial - 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 BioSphere 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, 5.0 mL
glass vial with a Screw-top cap, packaged in a peel-away tray,
available in 5 vials per package.
• Each vial contains either 1.0 mL or 2.0 mL of Embosphere
Microspheres in pyrogen-free, sterile, physiological saline. Total
volume of saline and Microspheres is 5 mL.
____________________________________________________
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 arteries supplying the lesion not large enough to
accept Embosphere Microspheres
• Presence of collateral vessel pathways potentially endangering
normal territories during embolization
• 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.