Storage, Handling, And Disposal; Rigid Cystoscope Lens; Rezūm Delivery Device; Rezūm Generator - Boston Scientific REZUM Mode D'emploi

6. Report all incidences of manual needle retraction to Boston Scientific Customer
Service. Clean device and return to Boston Scientific.
Warning: Do not remove device from the patient if the needle is not fully retracted. In
case of incomplete needle retraction, manually retract needle before removing the
device from the patient. Do not attempt to reassemble device for reuse after manual
needle retraction.

STORAGE, HANDLING, AND DISPOSAL

Rigid Cystoscope Lens

Refer to the rigid cystoscope lens packaging insert instructions for use for care,
cleaning and handling.
Rezūm™ Delivery Device
The Delivery Device is shipped sterile. If the package sterile barrier is broken or missing,
do not use the product.
The Delivery Device must not be reused or re-sterilized. It is for single use only.
The Delivery Device is packaged for easy transfer to the sterile field. The Delivery
Device should be handled with care at all times. The storage area should have good
ventilation, store in a cool, dry, dark place.
After use, discard the Delivery Device in accordance with local environmental
regulations for biohazards material.
Caution: The Delivery Device is intended for single-use only. Do not reuse, reprocess
or resterilize the device. Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or create a risk of contamination of the device,
which could result in patient injury or illness.
Rezūm Generator
1. Unplug the power cord and store the cord with the Generator.
2. Clean the Generator as per the instructions found in the Rezūm Operator's Manual.
3. Close the display screen to protect it from damage.
4. Store the Rezūm Generator in a safe, clean and dry location.
5. To transport the Rezūm Generator, use handle to carry.

Disposal of the Product, Accessories and Packing Materials

Dispose of all products, accessories and packaging materials in accordance with
hospital, administrative and/or local government policy.

PIVOTAL CLINICAL STUDY SUMMARY

Efficacy

The Rezūm II Study was a multicenter, randomized, controlled, double-blinded study
comparing the improvement in BPH symptoms at baseline and at 3 months post-
procedure, as measured by IPSS, for subjects in the Treatment Arm as compared
to subjects in the Control Arm. The Treatment Arm consisted of subjects receiving
injections of water vapor into targeted zones of the prostate. The Control Arm consisted
of subjects receiving a rigid cystoscopy with simulated active treatment sounds. The
Treatment Arm demonstrated clinically, and statistically, significant mean improvement
as compared to the Control Arm. The difference between the two arms was highly
significant and the pre-specified, 3-month primary endpoint was met (p < 0.0001).
The graphs below summarize the Treatment Arm outcomes through 4 years for IPSS,
Qmax, and Quality of Life.

Graph 1. Mean IPSS Over Time.

*Changes relative to baseline are significant, p < 0.001.

Graph 2. Mean Qmax Over Time.

*Changes relative to baseline are significant, p < 0.001.

Graph 3. Mean QoL Over Time.

*Changes relative to baseline are significant, p < 0.001.

REPORTED ADVERSE EVENTS

A summary of the adverse events reported and adjudicated in the Rezūm II Pivotal study
at treatment out through report date of February 9, 2019 is presented in the table below.
After unblinding at 3 months, the primary study endpoint, control subjects who elected to
proceed were requalified by inclusion criteria and eligible to participate in a crossover
study to receive thermal therapy. There were no unanticipated adverse device effects
or reports of de novo erectile dysfunction, rectal wall injury, or fistula. Fifty-seven
percent of the Treatment and Crossover subjects did not report any procedure or device
related AEs. Eighty percent of the adverse events reported occurred within the first 30
days post-procedure and were typically of short duration.
There was a total of 6 procedure and/or device related Serious Adverse Events (SAE)
reported in a total of 4 Treatment and Crossover subjects. One subject experienced
extended urinary retention due to untreated intravesical lobe protrusion. A second
subject had an allergic reaction to Xanax and was admitted to the hospital for nausea
and vomiting. A third subject experienced bladder neck contracture and bladder calculi,
which resolved within 30 days. A fourth subject was diagnosed with urosepsis following
cystoscopy, which resolved with medication.
As of February 9, 2019, 89% of the adverse events have resolved. The remaining ongoing
events listed will be assessed at the patients' next clinical study follow up visits. Events
will be updated annually out to five years.
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Black (K) ∆E ≤5.0