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Acessa
ProVu System User's Guide
®
EQ-5D Health State Score
13.12.
The EQ-5D score ranges from 0 to 100. An increase in the score post treatment indicates less disease burden.
100
80
60
40
20
0
13.13.
Overall Treatment Effect (OTE) Survey
The results of the OTE surveys showed that 94% of the subjects responded that they were very satisfied, moderately
satisfied, or somewhat satisfied with the treatment. At 12-months post treatment, 98% of the subjects reported that
they would probably or definitely recommend the procedure to their friends with the same health problem. When
asked about effectiveness of the treatment, at least 94% of the subjects responded that the treatment had been
somewhat, moderately, and very effective in eliminating their symptoms.
Would Recommend Procedure to a Friend
Felt Treatment was Effective in Eliminating Symptoms
13.14.
Data regarding return to work and return to normal activities
A total of 88 subjects reported that they were working. Subjects returned to work in a median of 5 days and all subjects
reported that they returned to normal in a median of 9 days. Ninety-six percent of the subjects in the Acessa Health
study were treated on an outpatient basis.
13.15.
Data regarding pregnancy
Subjects recruited in the pivotal trial were to have completed their childbearing and were counseled to practice
contraception. Despite this requirement, three subjects became pregnant within one year following the RF treatment
and one subject became pregnant in the second year of follow up. One pregnancy resulted in a spontaneous abortion
in the first trimester, one progressed normally resulting in a vaginal delivery, and two subjects had a C-section at 37
weeks due to hypertension (n=1) or gestational diabetes with hypertension (n=1). The latter C-section resulted in
anemia which required several post-operative blood transfusions (see Safety Section 12.6.1). Patients should be
counseled that there are limited data regarding pregnancy following RF ablation of fibroids.
13.16.
Data regarding calcified fibroids
Seven subjects (5.1%) had one or more calcified fibroids that were treated during the RF ablation procedure. Calcified
fibroids did not appear to impact the physician's ability to insert the tip of the Handpiece but the data are minimal
regarding calcified fibroids at this time.
13.17.
Therapeutic medications at 24 and 36 months post-treatment
One subject (1/124, 0.8%) reported taking Depo-Provera for vaginal bleeding at Month 24. Three subjects (3/124, 2.4%)
reported taking progesterone or GnRH agonist for vaginal bleeding prior to surgical reintervention within 12-24 months
post treatment. Between the 24 and 36 months visits, one subject (1/112, 0.9%) reported taking oral contraceptives,
one subject (1/112, 0.9%) reported taking Depo-Provera prior to her reintervention, and one subject (1/112, 0.9%)
reported taking oral progesterone.
CO 20-131 Revision: C
EQ-5D Scores at Baseline and at 3, 6, 12, 24, and 36 Months Post Treatment
85
71
Baseline
Month 3
(n=126)
(n=122)
OTE Survey at 12 Months Post Treatment
Expressed Treatment Satisfaction
86
85
Month 6
Month 12
(n=124)
(n=123)
0%
20%
40%
% of Subjects
PL-01-0040
86
84
Month 24
Month 36
(n=111)
(n=106)
94%
98%
94%
60%
80%
100%
27
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