Crossover Subjects Through 4 Year Follow-Up; Other Potential Adverse Events; Pain Management; Catheterization - Boston Scientific REZUM Mode D'emploi

Table 3. All Adjudicated Procedure and/or Device Related AEs for Treatment and

Crossover Subjects Through 4 Year Follow-up.

All Adjudicated Procedure and/or Device Related AEs for Treatment and Crossover
Subjects Through 4 Year Follow-up Percentage of Subjects
Adverse Event Procedure
or Device
Related
AEs
Dysuria 17%
Hematuria, Gross 12%
Hematospermia 6%
Urinary Frequency 6%
Decrease in Ejaculatory 5%
Volume
UTI, Suspected 5%
Urinary Retention 5%
Urinary Urgency 5%
Anejaculation 3%
Terminal Dribbling 3%
UTI, Culture Proven 3%
Epididymitis 2%
Erectile Dysfunction, 2%
Worsening
Gross Hematuria with 2%
Clots
Hematuria, Intermittent 2%
uncomplicated
Incomplete Voiding 2%
Pain/Discomfort with 2%
Ejaculation
Pain/Discomfort, Pelvic 2%
Pain/Discomfort, Penile 2%
Poor Stream 2%
Prostatitis 2%
Splayed Stream 2%
Urethral Stricture 2%
Gross Hematuria with 1%
retention
Hematuria, Micro 1%
Urinary Incontinence, 1%
Urge
Urinary Tract Infection 1%
(UTI)
Total 43%
The following events were reported in < 1% of subjects and were mild or moderate
in severity unless otherwise indicated: anxiety, bladder neck contracture (severe),
bladder stone formation (severe), catheter malfunction, decrease in orgasm pleasure,
delay in healing, fever, hesitancy, irritative voiding symptoms, nausea, pain/discomfort
(right testicle, abdomen, leg, other, perineum), prostate perforation, phlebitis of arm,
prostatic calculi, pyuria, retrograde ejaculation, urosepsis following cystoscopy
(severe), shingles on left lower thigh, urethral injury, urinary incontinence (mixed, stress
(resolved)), vomiting, hypotension.

Other Potential Adverse Events

The following adverse events have not been reported in these clinical trials: de novo erectile
dysfunction, pelvic abscess, rectal wall injury, and fistula. Delivering a form of thermal
therapy or misuse of the device has the potential for producing these adverse effects.

Pain Management

The clinical study did not require specific medications to be used and investigators were
instructed to use their clinical judgment in determining what medications, if any, to use on
a subject-by-subject basis. Of the 196 subjects treated in the study 135 (69%) received oral
sedation, 41 (21%) received a prostate block, and 20 (10%) received IV sedation.
Black (K) ∆E ≤5.0
Severity Resolved
AEs
Mild Moderate Severe
14% 4% 0% 97%
11% 1% 0% 100%
6% < 1% 0% 100%
5% 1% 0% 82%
4% < 1% 0% 33%
4% 1% 0% 100%
< 1% 4% < 1% 100%
3% 2% 0% 78%
2% < 1% 0% 0%
2% < 1% 0% 60%
1% 2% 0% 100%
< 1% 2% 0% 100%
2% < 1% 0% 0%
1% < 1% 0% 100%
1% < 1% 0% 100%
< 1% 1% 0% 100%
0% 2% 0% 100%
1% < 1% < 1% 100%
2% 0% 0% 100%
2% 0% 0% 100%
1% 1% 0% 100%
< 1% 1% 0% 100%
0% 2% 0% 100%
0% 1% 0% 100%
1% 0% 0% 100%
< 1% < 1% 0% 100%
1% 0% 0% 100%
36% 21% 2% 89%
Table 4. Types of Medication Used.
Types of Medication # of Subjects (N=196)
Oral Pain Medication 135
Prostate Block 41
IV Sedation 20

Catheterization

Catheterization occurred prior to discharge in 90% of subjects (122 subjects) in the
Treatment Arm and 20% of subjects (12 subjects) in the Control Arm. Of the 122 subjects in
the Treatment Arm who were catheterized immediately post-procedure, 68% (83 subjects)
were catheterized due to "physician discretion." The mean duration of immediate post-
procedure catheterization was 3.4 days for subjects in the Treatment Arm and 0.9 days for
subjects in the Control Arm. This difference in catheterization rates for the two arms of the
Study is to be expected due to the fact subjects in the Treatment Arm received thermal
vapor treatments resulting in anticipated inflammatory healing effect.
Table 5. Catheterization.
Subjects with catheterization
performed
Duration of catheterization, days
Mean ± Std (N)
Median [Min - Max]
Four subjects with a treated median lobe were re-catheterized due to retention for
an average of 5 days. An additional 3 subjects were re-catheterized due to multiple
cystoscopic examinations outside of the protocol during the early tissue healing phase
(first 90 days post-procedure).

Subsequent Treatments

Out of 188 subjects treated in the Treatment Arm, and Crossover group 9 subjects (5%)
sought alternative treatment options within 4 years post initial Rezūm™ treatment.

Graph 4. Subsequent Retreatments (Cumulative).

Supplier's Declaration of Conformity

47 CFR § 2.1077 Compliance Information
Unique Identifier:
Rezūm
Responsible Party – U.S. Boston Scientific Corporation
Contact Information 300 Boston Scientific Way
Marlborough, MA 01752
508-382-9555
www.bostonscientific.com
FCC Compliance This device complies with Part 18 of the FCC Rules
Statement:
For further information, see FCC web site for a complete
description of all requirements.
10
Percentage of Subjects
69%
21%
10%
Treatment (N=135) Control (N=61)
90.4% (122/135) 19.7% (12/61)
3.4 ± 3.2 (123) 0.9 ± 0.8 (12)
2.9 (0.0 - 30.9) 0.9 (0.0 - 2.0)
M006D2201-0031 GTIN 08714729996996
G2200-003 GTIN 0855357006003