Boston S
cientific (Master Brand DFU
Template 8.2677in x 1
1.6929in
A4, 9223851
9A), eDFU
, MB, R
ez
ū
m, en, 50849555-0
1A
Black (K) ∆E ≤5.0
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
Treatment (N=135)
Control (N=61)
90.4% (122/135)
19.7% (12/61)
Duration of catheterization, days
Mean ± Std (N)
Median [Min - Max]
3.4 ± 3.2 (123)
2.9 (0.0 - 30.9)
0.9 ± 0.8 (12)
0.9 (0.0 - 2.0)
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 Rez
ū
m™ treatment.
Graph 4. Subsequent Retreatments (Cumulative).
Supplier’s Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Unique Identifier:
Rez
ū
m
M006D2201-003
G2200-003
GTIN 08714729992547
GTIN 0855357006003
Responsible Party – U.S. Contact
Information
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
508-382-9555
www.bostonscientific.com
FCC Compliance Statement:
This device complies with Part 18 of the FCC Rules
For further information, see FCC web site for a complete description of all requirements.
WARRANTY
Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design
and manufacture of this instrument.
This warranty is in lieu of and excludes all other warranties
not expressly set forth herein, whether express or implied by operation of law or otherwise,
including, but not limited to, any implied warranties of merchantability or fitness for a particular
purpose.
Handling, storage, cleaning and sterilization of this instrument as well as other factors
relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond BSC’s
control directly affect the instrument and the results obtained from its use. BSC’s obligation under
this warranty is limited to the repair or replacement of this instrument and BSC shall not be liable
for any incidental or consequential loss, damage or expense directly or indirectly arising from the
use of this instrument. BSC neither assumes, nor authorizes any other person to assume for it, any
other or additional liability or responsibility in connection with this instrument.
BSC assumes no
liability with respect to instruments reused, reprocessed or resterilized and makes no warranties,
express or implied, including but not limited to merchantability or fitness for a particular purpose,
with respect to such instruments.
Storz is a registered trademark of Karl Storz GmbH & Co.
Richard-Wolf is a registered trademark of Richard Wolf GmbH.
Tyvek is a registered trademark of DuPont.
