How Supplied; Clinical Studies - Boston Scientific Contour Mode D'emploi

8. For all indications: Carefully inject Contour™ Embolization Particles under
fluoroscopic visualization, observing contrast flow rate. Appreciate a reduction
in flow acceptance, and decrease infusion accordingly. Exercise conservative
judgment in determining embolization endpoint. Terminate infusion before
complete vessel occlusion has occurred.
The UFE specific end point is generally described as complete stasis or near stasis,
with the main uterine artery remaining patent, but with negligible residual flow. This
endpoint generally corresponds to an angiographic image of a patent uterine artery
with all its distal branches occluded. As with any embolic particle, in order to avoid
a false endpoint with early recanalization, the embolization endpoint should be
confirmed by leaving the catheter in the uterine artery for approximately 5 minutes
after the apparent conclusion of the procedure. The endpoint should then be
confirmed with an injection of contrast and observation with fluoroscopy. Additional
particles can then be administered to reach the stated endpoint if flow restoration
due to redistribution is identified on this contrast injection.
Caution: "Clumping" of Contour Embolization Particles or catheter obstruction
may be a function of contrast dilution volume; ensure that enough contrast
is utilized such that Contour Embolization Particles are free floating and not
observed as aggregates.
9. Should catheter obstruction occur, remove the catheter from the patient. Do not
use forceful injection, guidewires or other instruments to dislodge the blockage.
Do not continue using a catheter which has been obstructed as damage to the
device may have occurred.
10. Upon completion of the procedure, remove catheter from the patient with gentle
suction to ensure any remaining particles are maintained within the catheter
lumen as it is withdrawn.

HOw SUPPlIED

Boston Scientific products are sterile in unopened, undamaged packaging. Packaging
is designed to maintain sterility unless the primary product pouch has been opened
or damaged. Do not use if package is opened or damaged. Do not use if labeling is
incomplete or illegible. Store in a cool, dry, dark place.

ClInICal STUDIES

THE Contour Embolization Particles Clinical Study Summary
UfE Clinical Study Summary
Study Design
A prospective, multi-center trial was conducted to study uterine fibroid embolization
(UFE) using Contour Embolization Particles for the treatment of symptomatic uterine
fibroids. A total of 209 women were administered anesthesia and were defined as the
intent-to-treat population (ITT), 149 in the UFE arm and 60 in the myomectomy control
arm. Of the 149 UFE subjects, 2 subjects were never treated with embolic, making
the number of subjects treated for their symptomatic uterine fibroids 147 for Contour
Embolization Particles and 60 women were treated for their symptomatic uterine fibroids
in a concurrent, non-randomized control arm with either abdominal or laparoscopic
myomectomy. 16 sites participated in the study; 11 of which performed UFEs and 10 of
which performed myomectomy.
The study was designed to evaluate the safety and effectiveness of Contour Embolization
Particles when used in the uterine fibroid embolization procedure for the management
of symptomatic uterine fibroids.
Primary Study Endpoint
The primary endpoint evaluated in this study was the improvement of fibroid related
symptoms from baseline to 6-months post-procedure using the Overall Fibroid Symptom
component of a validated Uterine Fibroid Quality of Life (UFQoL) Questionnaire.
Subjects in the UFE cohort acted as their own control and were considered a success
at 6-months post-procedure if they had an increased score from baseline to 6-months
post-procedure of ≥ 5 points on the Overall Fibroid Symptom component of the UFQoL
which includes assessment of:
• Heavy bleeding
• Abdominal swelling
• Pelvic pain
• Backaches
• Bowel problems
• Frequent urination
• Pain with urination
• Poor appetite
• Hot flashes
• Vaginal dryness
• Painful period
Secondary endpoints included:
• Overall adverse event rates for both the myomectomy and UFE cohorts
• Success for Overall Fibroid Symptom scores between myomectomy and UFE
cohorts at 6-months post-procedure
• Quality of Life measures for UFE and myomectomy cohorts at 3 and 6-months
post-procedure
• Time to return to normal activities between UFE and myomectomy cohorts
• Change in dominant fibroid size at 6-months post-procedure as compared to
pre-procedure (UFE cohort)
• Relationship between change in dominant fibroid size and fibroid specific quality
of life measures (UFE cohort)
Subject eligibility criteria for the study included:
Inclusion Criteria
• Diagnosis of symptomatic uterine myoma
• Record of a normal pap smear within the last 12 months
• Menstrual cycles within every 22 to 35 days (pre-menopausal)
• Age ≥ 30
• If subject was currently not taking hormonal contraceptives, subject had been off
hormonal contraceptive for a minimum of 3 months prior to study enrollment and
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