Patient Counseling Information - Merit Medical Embosphere Mode D'emploi

dislodgment, and nerve and/or circulatory injuries, which may result
in leg injury)
• Allergic reaction to medications (e.g., analgesics)
• Allergic reaction to contrast media or embolic material
• Pain and/or rash, possibly delayed from the time of embolization
• Death
• Blindness, hearing loss, loss of smell, and/or paralysis
• Additional information is found in the Warnings section
UFE Specific Potential Complications
• The most frequently anticipated post procedure complications are
abdominal pain, discomfort, fever and/or nausea, collectively known
as "Post-embolization Syndrome. " Some patients may also experience
constipation. This is generally managed with prescription or over-the-
counter medications.
• Premature ovarian failure (i.e., menopause)
• Amenorrhea
• Infection of the pelvic region
• Uterine/ovarian necrosis
• Phlebitis
• Deep vein thrombosis with or without pulmonary embolism
• Vaginal discharge
• Tissue passage, fibroid sloughing, or fibroid expulsion post UFE
• Post-UFE intervention to remove necrotic fibroid tissue
• Vagal reaction
• Transient hypertensive episode
• Hysterectomy
PAE Specific Potential Complications
• Non-targeted embolization of the rectum, bladder, scrotum, penis,
or other areas
• The most frequent post-procedure complication includes "Post-
PAE Syndrome," which includes nausea, vomiting, fever, pelvic pain,
burning sensation, dysuria, and frequent or urgent urination
• Skin burn (radiation exposure) from prolonged fluoroscopy time
• Blood in urine, semen, or stool
• Bladder spasm
• Urinary tract infection
• Urinary retention
• Constipation
Neurological Specific Potential Complications
• Ischemic stroke or ischemic infarction
• Neurological deficits, including cranial nerve palsies
STORAGE AND STERILITY
• Embosphere Microspheres must be stored in a cool, dry and dark
place in their original syringe and packaging.
• Use by the date indicated on the syringe label.
• Do not freeze.
• Do not resterilize.
INSTRUCTIONS FOR USE
Inspect packaging prior to use to ensure seal integrity for maintenance
of sterility.
• Carefully evaluate the vascular network associated with the lesion
using high resolution imaging prior to beginning the embolization
procedure.
• Embosphere Microspheres are available in a range of sizes. Because
of the potential for misembolization and the inherent variability in
sphere sizes, 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.
• When embolizing arteriovenous malformations (AVMs), choose an
Embosphere Microsphere size that will occlude the nidus without
passing through the AVM.
• When embolizing uterine fibroids, choose an Embosphere
Microsphere size of 500 microns or greater.
• For prostatic artery embolization, it is recommended to use
Embosphere Microspheres 300-500 microns.
• Choose a delivery catheter based on the size of the target vessel and
the microsphere size being used. Embosphere Microspheres can
tolerate temporary compression of up to 33% in order to facilitate
passage through the delivery catheter.
• Introduce the delivery catheter into the target vessel according to
standard techniques. Position the catheter tip as close as possible to
the treatment site to avoid inadvertent occlusion of normal vessels.
• Embosphere Microspheres are not radiopaque. It is recommended
that the embolization be monitored using fluoroscopic visualization
by adding the appropriate amount of contrast medium to the
physiologic suspension fluid.
To Deliver Embosphere Microspheres
• Match the total volume in the syringe with the same volume of
undiluted contrast, which will result in a 50% microsphere/saline
and 50% contrast solution. Remove all air from the syringe. To evenly
suspend the Embosphere Microsphere/contrast solution, gently
invert the 20 mL syringe several times. Attach the 20 mL syringe to one
port of the luer-lock 3-way stopcock. Attach a 1 mL or 3 mL injection
syringe to another port on the stopcock and, if desired, a delivery
catheter may be attached to the remaining port on the stopcock. Wait
several minutes to allow the Embosphere Microspheres to suspend in
the solution. Draw the Embosphere Microspheres/contrast solution
into the injection syringe slowly and gently to minimize the potential
of introducing air into the system. Purge all air from the system prior
to injection. Inject the Embosphere Microspheres/contrast solution
under fluoroscopic visualization with the injection syringe using
a slow pulsatile injection while observing the contrast flow rate. If
there is no effect on the flow rate, repeat the delivery process with
additional injections of the Embosphere Microspheres/contrast
solution. Consider using larger sized Embosphere Microspheres if the
initial injections do not alter the contrast flow rate. If the Embosphere
Microspheres/contrast solution requires re-suspension, gently invert
the 20 mL syringe several times. Exercise conservative judgment in
determining the embolization endpoint.
• Femoral puncture can result in arterial spasm. This may predispose
to femoral thrombosis (e.g., leg injury). Femoral patency should be
re-assessed prior to final catheter removal.
• Upon completion of the treatment, remove the catheter while
maintaining gentle suction so as not to dislodge Embosphere
Microspheres still within the catheter lumen.
• Apply pressure to the puncture site until hemostasis is complete.
• Discard any open, unused Embosphere Microspheres.
Additional UFE Specific Instructions
• At the discretion of the physician, pneumatic compression devices
may be used for patients currently taking hormone therapy, uterine
volume >1000cc, and patients that are overweight to lower the risk of
deep vein thrombosis.
• Embolization should be stopped when the vasculature surrounding
the fibroid can no longer be visualized but before complete stasis in
the uterine artery. There is an increased chance of retro-migration of
Embosphere Microsphere into unintended blood vessels as uterine
artery flow diminishes.
Additional PAE Specific Instructions
• A Foley catheter, with its balloon inflated with a mixture of contrast
and saline, may be placed prior to PAE for use as a landmark during the
embolization procedure.
• PAE can be performed by either radial or femoral access.

PATIENT COUNSELING INFORMATION

• Patients should have a clear understanding prior to embolization of
who will provide their post procedure care and whom to contact in
case of an emergency after embolization.
• Embolization patients should have an understanding of the potential
benefits, risks, and adverse events associated with embolization. In
particular, patients should understand that there is a chance their
symptoms will not improve following embolization.
UFE CLINICAL STUDY SUMMARY
Study Design
A prospective multi-center trial was conducted to study uterine fibroid
embolization (UFE) using Embosphere Microspheres for treatment of
symptomatic uterine fibroids. A total of 132 women who desired to keep
their uterus and avoid surgery were treated by UFE in the study; 30 in an
initial feasibility study and 102 in the pivotal study. Those patients included
in the pivotal study were followed for 3 years, with clinical measures of
outcome obtained at 3, 6, 12, 24 and 36 months after treatment. Seven
investigational sites participated in the study.
The study was designed to determine whether UFE using Embosphere
Microspheres could reduce symptoms associated with symptomatic
fibroids, such as abnormal bleeding, pain, discomfort, and urinary
problems.
Primary Study Endpoints Included
• Reduction in menstrual bleeding from baseline to 6 months post-UFE
as measured using a Pictorial Bleeding Assessment Chart (PBLAC)
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