Merit Medical Embosphere Microspheres Prefilled Syringe IFU-US - Manual (Page 5)

• 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 (AVM), 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.
• 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 > 1000 cc, 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.
UFE 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.
Patient information brochures are available and distributed by
Merit Medical, Inc.
• UFE candidates should have an understanding of the potential
benefits, risks, and adverse events associated with UFE. In
particular patients should understand that there is a chance
their fibroid-related symptoms will not improve following UFE.
UFE CLINICAL STUDY SUMMARY:
Study Design
A prospective multi-center trial was conducted to study 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. A concurrent, non-
randomized group of 50 patients undergoing hysterectomy was
also included for comparison of safety to the UFE group. Eleven
investigational sites participated in the study: seven of which
performed UFEs and six of which performed hysterectomies.
The study was designed to determine whether UFE using
Embosphere Microspheres could reduce symptoms associated
with the 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)
• Improvement in bulk symptoms (pelvic pain, pelvic discomfort/
bloating, and urinary dysfunction) as measured using a patient
symptom questionnaire
• Improvement in quality of life as measured using the SF-12
Health Status Questionnaire
Secondary endpoints included:
• Other measures of changes in menstrual bleeding
• Reduction of uterus and fibroid size
• Hospitalization time
• Time to return to normal activities
• Evaluations of patient satisfaction with the procedure
Adverse events and complications were also evaluated with
respect to type, rate, and severity.
Eligibility criteria included age between 30 and 50 years, inclusive,
infertile or no plans to become pregnant, one or more symptomatic
uterine fibroids, uterine volume 250 cc or fibroid volume 4 cc, and
baseline PBLAC ≥ 150. Women were excluded from the study if
they were pregnant, had a history of pelvic inflammatory disease,
submucosal fibroid(s) with more than 50% growth into the uterine
cavity, pedunculated serosal fibroid(s) as the dominant fibroid(s),
significant collateral feeding by vessels other than uterine artery,
adenomyosis as the dominant cause of symptoms, endometrial
or pre-malignant hyperplasia, any malignancy of the pelvic
region, any active infection of the pelvic region, known allergy to
IV contrast or gelatin, bleeding diathesis, immunocompromised,
post-menopausal or baseline FSH > 40 mIU/mL, or treatment with
GnRH agonist within the previous 3 months.
Pre-treatment evaluations included routine gynecological exam
and testing, standard laboratory testing, ultrasound or MRI,
menstrual bleeding record (UFE group), and self-assessment
questionnaires relating to overall health (SF-12), menstrual
bleeding, and fibroid symptoms. Patients were evaluated at 1-3
weeks, 3 months, 6 months and 12 months. PBLAC scores were
obtained at 3 and 6 months.
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