Efficacy; Surgical Reintervention Rate; Uterine And Fibroid Volume - Hologic Acessa ProVu User Manual

Acessa ProVu System User's Guide
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Adverse Events Classified as Possibly, Probably, or Definitely related to the Device – Pelvic Abscess, serosal colon injury,
lower abdominal pain superficial uterine serosal burn and post-procedural hemorrhage were each reported as single
adverse events for a total device-related adverse event rate of 3.6%.
Adverse Events Classified as Possibly, Probably, or Definitely related to the Procedure - Lower abdominal pain, dysuria
and dysmenorrhea were each reported in 3 of the 137 subjects (2.2%). Procedural pain, procedural vomiting, dizziness
and hypoesthesia were each reported in 2 of the 137 subjects (1.5%)Cystitis, pelvic abscess, wound infection, oral
hypoesthesia, vomiting, pain, post-operative anemia, uterine serosal burn, serosal colon injury, post procedural
hemorrhage, post-procedure shivering, incisional rash, contusion, incisional site hemorrhage, wound hematoma,
spontaneous abortion, hematuria, premenstrual syndrome, atelectasis, seroma, and endometritis were each reported
as single adverse events (0.7%)..
Adverse Events Classified as Serious -Seventeen of the adverse events occurring in fifteen subjects were considered
serious; atelectasis (1 subject, 0.7%), chest pain (2 subjects, 1.5%), viral infection with otitis externa (1 subject, 0.7%),
pyelonephritis (1 subject, 0.7%), uterine hemorrhage resulting in anemia and requiring blood transfusion (1 subject,
0.7%), Achilles tendon rupture and intervertebral disc repair (1 subject, 0.7%), laceration in serosa of colon (1 subject,
0.7%), spontaneous abortion (1 subject, 0.7%) pelvic abscess (1 subject, 0.7%), hemiparesis (1 subject, 0.7%), dyspnea
(1 subject, 0.7%), motor vehicle accident, (1 subject, 0.7%), anemia, resulting in blood transfusion following Cesarean
delivery, (1 subject, 0.7%), shortness of breath and pulmonary embolism, (1 subject, 0.7%) postoperative anemia
following a reintervention (hysterectomy), and cerebrovascular accident (1 subject, 0.7%). Of these serious adverse
events, only the pelvic abscess and the serosal colon injury were considered to be both device and procedure
related. Additionally, the atelectasis was considered definitely related to the procedure and the spontaneous abortion
and anemia were possibly related to the procedure.
13.8.

Efficacy

Menstrual Blood Flow as Assessed by Alkaline Hematin (AH): In the evaluable subjects (n=124), the mean reduction in
menstrual blood flow at 12 months post treatment was 103.6 ml. One hundred four of the 124 (83.9%) evaluable
subjects experienced a reduction in bleeding at 12 months post treatment. Nineteen of the 124 subjects (15.3%)
experienced an increase in bleeding at 12 months post baseline. When including the subjects lost to follow up as
treatment failures, 40.2% (95% CI 31.6% - 48.7%) met the protocol criterion for bleeding relief (defined as ≥50%
reduction in menstrual bleeding at 12 months post-treatment) though this did not meet the pre-specified study
hypothesis that the lower bound of the 95% CI would be ≥45%.
13.9.

Surgical Reintervention Rate

There was 1 subject (1/127, 0.8%) in the primary full analysis set (PFAS) who had a surgical reintervention (UAE) for
bleeding after she withdrew from the study but prior to 12 months of follow up. The study did not include a
prospectively developed hypothesis test for the 24 or 36-month surgical reintervention rate. The 24-month status
has been documented on all of the 124 subjects in the PFAS who entered their second year of follow up. Three
subjects were lost to follow up in the second year (3/124, 2.4%) and six of the remaining subjects (6/121, 5.0%)
reported a surgical reintervention for fibroid-related bleeding between 12 and 24 months (4 hysterectomies and 2
hysteroscopic myomectomies). One subject reported an endometrial ablation at 16 months for heavy bleeding with
no evidence of fibroids and one additional subject became pregnant. One hundred thirteen subjects in the PFAS
entered their third year of follow up. Four subjects underwent a hysterectomy (4/113, 3.5%) and two were lost to
follow up prior to the 36 month visit. An additional three subjects (3/107, 2.8%) had hysterectomies after undergoing
their 36 month visit. In total, 14 subjects have undergone surgical reintervention for fibroid-related bleeding for a
cumulative reintervention rate of 11.0%*
*based on Kaplan-Meier statistical procedure

Uterine and Fibroid Volume

13.10.
RFA treatment resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment
and post treatment contrast-enhanced MRI, at 3 and 12 months post treatment. At 12 months post treatment, the
mean reduction in uterine volume (n=128) was 25.1% and the mean reduction in fibroid volume (n=119) was 44.3%.
CO 20-131 Revision: C
PL-01-0040
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