Boston Scientific Contour Mode D'emploi page 8

Myolysis
Dilatation & Curettage
Ovarian Cystectomy
Endometrial Ablation or Fulguration
Tubal Ligation
Salpingo-Oophorectomy
Other
length of Menstrual bleeding (days)
Mean
Std Dev
Dominant Symptom
Abnormal Bleeding
Bulk/Pressure
Pelvic Pain
Infertility
Other
Duration of Dominant Symptom (Months)
Mean
Std Dev
Median
Minimum
Maximum
number of fibroids Present
None
One
Two
Three
Four
Five
Six-Ten
> Ten
Missing
location of first Dominant fibroid
Intramural
UfE cohort Myomectomy Cohort
(n=149) (n=60)
2 (1.3%) 0 (0.0%)
44 (29.5%) 14 (23.3%)
6 (4.0%) 2 (3.3%)
6 (4.0%) 1 (1.7%)
28 (18.8%) 1 (1.7%)
1 (0.7%) 2 (3.3%)
30 (20.1%) 17 (28.3%)
7.0 6.2
2.67 2.47
77 (51.7%) 20 (33.3%)
38 (25.5%) 16 (26.7%)
29 (19.5%) 18 (30.0%)
0 (0.0%) 2 (3.3%)
5 (3.4%) 4 (6.7%)
27.7 36.5
37.64 43.73
12.0 24.0
0.03 0.07
204 252
2 (1.3%)* 1 (1.7%)**
9 (6.0%) 5 (8.3%)
10 (6.7%) 4 (6.7%)
10 (6.7%) 8 (13.3%)
10 (6.7%) 7 (11.7%)
6 (4.0%) 2 (3.3%)
27 (18.1%) 14 (23.3%)
75 (50.3%) 13 (21.7%)
0 (0.0%) 6 (10.0%)
88 (59.1%) 26 (43.3%)
Submucosal
Submucosal Pedunculated
Subserosal
Subserosal Pedunculated
Other
Cannot Determine
Missing
Size of Dominant fibroid (cm )
3
N
Mean
Std Dev
Median
Minimum
Maximum
Note: *One subject had an ultrasound at baseline that showed evidence of the presence of fibroids, prior to her
enrollment and UFE procedure. Another subject had a MRI at baseline that showed evidence of the presence
of fibroids, prior to her enrollment and UFE procedure. Subsequent to enrollment and treatment, the Core Lab
was unable to measure uterine fibroids for two subjects after reviewing each subject's baseline MRI. The Core
Lab noted no measurable fibroids and the presence of adenomyosis. **The Core Lab was unable to measure
uterine fibroids for one myomectomy subject because the subject's baseline MRI was considered corrupt and
could not be reviewed.
Study results
One hundred forty nine (149) UFE subjects and 60 myomectomy subjects were
considered intent-to-treat (ITT) and included in the FDA submission.
Procedure, Discharge, and recovery Information
In the majority (96.6%) of the UFE procedures, the investigators used a right common
femoral artery approach, while 3.4 % used a bilateral common femoral artery approach.
The majority (63.1%) of the Contour™ Embolization Particles used during the study was
355-500 microns, while 24.1% was 500-710 microns, and 12.7% was 250-355 microns. Many
of the UFE procedures used more than one size of Contour Embolization Particles.
A majority of the UFE subjects (96.0%) were under conscious sedation during the
procedure, 38.9% were under local anesthesia, 11.4% received epidural anesthesia,
0.7% received general anesthesia, and 6.0% used another form of anesthesia. The
majority (98.3%) of the myomectomy subjects were under general anesthesia during the
procedure, 1.7% were under local anesthesia, and 3.3% received epidural anesthesia.
In some of the UFE and myomectomy procedures, more than one form of anesthesia
was administered.
The mean total procedure time for the UFE subjects was 83.9 minutes (SD 47.44,
range 13 to 240 minutes) which was less than the mean total procedure time in the
myomectomy cohort of 141.6 minutes (SD 69.64, range 45 to 402 minutes).
8
UfE cohort Myomectomy Cohort
(n=149) (n=60)
1 (0.7%) 3 (5.0%)
17 (11.4%) 2 (3.3%)
8 (5.4%) 8 (13.3%)
31 (20.8%) 13 (21.7%)
0 (0.0%) 1 (1.7%)
2 (1.3%) 0 (0.0%)
2 (1.3%) 7 (11.7%)
147 53
182.12 226.92
208.978 196.394
114.72 185.75
0.63 6.45
1116.91 869.95
Th
w
32
P
B
of
su
th
(5
a
w
10
po
(0
de
O
Ta
S
C
C
≥
n
<
T
(
L
W
P
P
S
c
S
81
ba
th
in
S
O
si
m
ho
ac