References - Boston Scientific Contour Mode D'emploi

Symptom recurrence, Complications, and Pregnancy Post-Market
nd Study subjects were evaluated for symptom recurrence, complication and pregnancy
re at 1, 2, and 3-years post-procedure. Table # 7 summarizes the results obtained from the
d/ clinician completed clinical assessment:
Table 7. Symptom recurrence Post-Market
re
he
nt
he
fe Recurrence/New Fibroid Symptoms
Yes
ts
No
Missing
Other Symptoms
Yes
No
Missing
New Treatments
Yes
ly
No/Missing
s,
Specific Treatment
gh
ia
Repeat UFE
Myomectomy
Hysteroscopy
Hysterectomy
Drug Treatment
Other
Contour™ Embolization Particles UfE arm
(n=149)
Year 1 Year 2 Year 3
(n=120) (n=102) (n=88)
15 (12.5%) 14 (13.7%) 13 (14.8%)
105 (87.5%) 88 (86.3%) 75 (85.2%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
Year 1 Year 2 Year 3
13 (10.8%) 16 (15.7%) 15 (17.0%)
107 (89.2%) 86 (84.3%) 73 (83.0%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
Year 1 Year 2 Year 3
2 (1.7%) 6 (5.9%) 3 (3.4%)
118 (98.3%) 96 (94.1%) 85 (96.6%)
Year 1 Year 2 Year 3
0 (0.0%) 1 (1.0%) 0 (0.0%)
0 (0.0%) 1 (1.0%) 1 (1.1%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
0 (0.0%) 2 (2.0%) 2 (2.3%)
2 (1.7%) 2 (2.0%) 0 (0.0%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
Table 8. Complications and Pregnancy Post-Market
Complications Related to UFE
Procedure
Yes
No
Missing
Pregnant
Yes
No
Unknown
Missing
Specific Outcome
Complicated
Uncomplicated
Therapeutic Abortion
Spontaneous Abortion
Note: *03U06-Metallic taste in mouth last month. 09U04-"Something is there" in right upper leg below
right groin area. 10U11-"Onset menopause symptoms". **Subject 03U33-pregnancy reported at the 3-year
follow-up visit.

rEfErEnCES

UfE Indications
1. Walker WJ and Pelage JP. Uterine Artery Embolization for Symptomatic Fibroids:
Clinical Results in 400 Women with Imaging Follow-up. BJOG 2002; 109:1262-1272.
2. Goodwin S, McLucas B, Lee M, et al. Uterine Artery Embolization for the
Treatment of Uterine Leiomyomata Midterm Results. JVIR 1999; 10:1159-1165.
3. Spies J, Spector A, Roth A, et al. Complications after Uterine Embolization for
Leiomyomas. Obstetrics & Gynecology 2002; 100(5): 873-880.
4. Pron G, Cohen M, Soucie J, Garvin G, Vanderburgh L, et al. The Ontario Uterine
Fibroid Embolization Trial. Part 1. Baseline patient characteristics, fibroid burden,
and impact of life. Fertility and Sterility 2003; 79(1): 112-119.
5. Pron G, Bennett J, Common A, Wall J, et al. The Ontario Uterine Fibroid
Embolization Trial. Part 2. Uterine fibroid reduction and symptom relief after
uterine artery embolization for fibroids. Fertility and Sterility 2003; 79(1): 120-127.
6. Siskin GP, Englander M, Stainken, et al. Embolic Agents Used for Uterine Artery
Embolization. AJR 2000; 175: 767 773.
7. Spies JB, Scialli AR, Jha LC, et al. Initial Results for Uterine Fibroid Embolization
for Symptomatic Leiomyomata. JVIR 1999; 10: 1149-1157.
11
Contour Embolization Particles UfE arm
(n=149)
Year 1 Year 2 Year 3
(n=120) (n=102) (n=88)
*3 (2.5%) 0 (0.0%) 0 (0.0%)
117 (97.5%) 102 (100.0%) 88 (100.0%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
Year 1 Year 2 Year 3
0 (0.0%) 0 (0.0%) **1 (1.1%)
119 (99.2%) 102 (100.0%) 87 (98.9%)
1 (0.8%) 0 (0.0%) 0 (0.0%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
Year 1 Year 2 Year 3
0 (0.0%) 0 (0.0%) 0 (0.0%)
0 (0.0%) 0 (0.0%) 1 (1.1%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
0 (0.0%) 0 (0.0%) 0 (0.0%)