Contraindications - Merit Medical Embosphere Mode D'emploi

ENGLISH
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 the embolization of:
• Hypervascular tumors, including symptomatic uterine fibroids
• Arteriovenous malformations
• Prostatic arteries for symptomatic Benign Prostatic Hyperplasia (BPH)
in people with medication-refractory urinary obstructive symptoms
who are poor surgical candidates or refuse surgical therapy.
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.
CLINICAL APPLICATIONS FOR BENIGN PROSTATIC HYPERPLASIA
(BPH)
Prostatic artery embolization (PAE) is an alternative treatment for men
requiring treatment for relief of lower urinary tract symptoms (LUTS)
attributed to BPH, such as urinary frequency, inability to urinate,
incomplete emptying of bladder, difficulty starting urination, and straining
to urinate or weak urine stream.
MAGNETIC RESONANCE IMAGING
Embosphere Microspheres are made of tris-acryl polymer impregnated
with porcine gelatin and have no ferrous composition.
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, nonresorbable,
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 mL pre-filled
syringe, packaged in a peel-away tray, available in 5 syringes per
package.
• Each syringe contains approximately 1.0 mL or 2.0 mL of Embosphere
Microspheres in a 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, benign prostatic
hyperplasia and uterine fibroids) first, followed by indication-specific
information (i.e., UFE, PAE 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 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
Embosphere® Microspheres in a Prefilled Syringe - For Embolization
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
PAE Specific Contraindications
• Active urinary tract infection or prostatitis
• Prostate cancer
• Bladder cancer
• Chronic renal failure
• Bladder atonia, neurogenic bladder disorder, or other neurological
disorder impacting bladder function
• Bladder stones
• Urinary obstruction due to causes other than BPH, including urethral
stricture
• Excessive vessel tortuosity or severe atherosclerosis
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. The size
of Embosphere Microspheres 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.
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