Acessa
®
ProVu System User’s Guide
PL-01-0040
CO 20-131 Revision: C
21
12.3.
Results from Ex-Vivo Bovine Liver Studies
The system uses a power control mode for ablating target zones less than 1.5 cm in diameter. The electrode array is
not deployed when using power control mode and the ablation time is 1 minute or less. The following table shows
the average ablation zone and the recommended times at 0.0 deployment using an ex-vivo bovine liver at 15 W
power.
TISSUE: Liver
CONTROL MODE: Power
POWER: 15 W
ABLATION SIZE (cm)
DEPLOYMENT (cm)
TIME
POWER
MAJOR DIAMETER
MINOR DIAMETER
1.0 ± 0.11
0.8 ± 0.09
0.0
15 sec
15W
1.5 ± 0.06
1.2 ± 0.14
0.0
1 min
15W
12.4.
Representative Ablation Sizes in Ex-vivo Bovine Liver with Settings in Temperature Control
The system uses a temperature control mode for ablating target zones greater than 1.5 cm in diameter, and with the
electrode array deployed. The following table shows the average ablation zone and the recommended times and
deployments, using an ex-vivo bovine liver with a target temperature of 95°C.
TISSUE: Liver
CONTROL MODE: Temperature
TEMPERATURE: 95°C
ABLATION SIZE (cm)
DEPLOYMENT (cm)
TIME
TARGET
TEMPERATURE
MAJOR DIAMETER
MINOR DIAMETER
1.9 ± 0.06
1.7 ± 0.12
0.5
30 sec
95°C
2.1 ± 0.15
1.9 ± 0.15
1.0
1 min
95°C
2.7 ± 0.05
2.3 ± 0.11
1.5
2 min
95°C
3.3 ± 0.11
2.7 ± 0.25
2.0
3 min
95°C
3.9 ± 0.11
3.0 ± 0.21
2.5
4 min
95°C
4.2 ± 0.32
3.4 ± 0.23
3.0
5 min 30 sec
95°C
4.8 ± 0.32
3.7 ± 0.64
3.5
7 min
95°C
5.2 ± 0.04
4.3 ± 0.50
4.0
7 min 30 sec
95°C
5.6 ± 0.38
4.4 ± 0.38
4.5
8 min
95°C
6.0 ± 0.35
5.0 ± 0.69
5.0
12 min
95°C
13.
Clinical Studies – Fibroids
Prospective, non-randomized, longitudinal Phase II studies using the Acessa System were conducted at two separate centers to
establish early safety and effectiveness data. A total of 69 premenopausal females (average age 42.1 ±5.5 years); the average
reproductive status was gravida 2.8 ± 2.0 and para 2.1 ± 1.6. At the time of screening, 81% of the subjects reported having
regular menstrual cycles, and 77% reported having heavy-to-very heavy bleeding volume. Nearly 85% of the subjects reported
bleeding between periods. Fibroid symptoms of menorrhagia and dysmenorrhea were found in 98% and 38% of the subjects,
respectively. A total of 285 fibroids were ablated (median = 3) with one patient having 20 fibroids treated.
Results:
The mean uterine volume at baseline was 204.4 cm
3
. At 6 months and 12 months post-treatment, the mean uterine
volume was significantly reduced to 155.0 cm
3
(p= 0.012) and 151.4 cm3 (p = 0.009), respectively. The percent of subjects
demonstrating reduced uterine volume in contrast to baseline was 82.2%, 80.0%, and 79.3% at the 3-, 6-, and 12-month visits,
respectively. At baseline, 77% of subjects reported heavy to very heavy bleeding prior to the treatment. After 12 months post-
treatment, 3.5% (p<0.0001) reported heavy to very heavy bleeding based on the patient reported survey. The UFS-QOL
questionnaire was administered at baseline and at all follow-up visits. The mean percent improvement in Symptom Severity
Scores from baseline to post-treatment was 59.6% at 3 months, 65.0% at 6 months, and 79.0%, at 12 months. The mean
percent change in HRQL Scores from baseline to 3 months post-procedure was 41.6%, from baseline to 6 months post-
procedure was 39.7%, and from baseline to 12 months post-procedure was 42.9%. Overall, sixty-five subjects (94.2%) reported
improved Symptom Severity Scores and sixty-one subjects (88.4%) reported improved HRQL Scores. In terms of safety, there
was only one (1.4%) serious adverse event (i.e., abdominal wall hematoma), which was determined to be related to the
procedure. It was treated by laparotomy and vessel ligation.
The device pivotal (Phase III) study included the treatment of 137 women with symptomatic fibroids including menorrhagia. A
total of 11 centers in the United States (9 centers) and Latin America (2 centers) and 13 investigators participated in the study:
