Perform The Rezūm Vapor Treatment - Boston Scientific REZUM Mode D'emploi

Note: Pre-treatment vapor cycle must be completed prior to inserting Delivery Device
into the patient.
Perform the Rezūm™ Vapor Treatment
1. Confirm the Generator display is showing the Therapy Screen.
2. Coat the shaft of the Delivery Device with water-soluble lubricating or anesthetizing gel.
3. Attach light cord and video camera to the scope lens.
4. Using finger, activate the saline flush by applying gentle pressure to the Flush
Activation Button.
5. Carefully insert the Delivery Device into the urethra through the meatus.
Warning: Excessive pressure while using Flush Activation Button may cause
unintended deployment of the needle.
Warning: Ensure needle is fully retracted by viewing needle position through scope
lens. If needle is not retracted prior to insertion of the Delivery Device, damage to
urethra may occur.
Warning: No modification of this equipment is allowed. Do not attempt to service or
maintain the generator while in use with a patient.
6. While examining prostatic urethra, locate the apex of the prostate and the bladder.
A TRUS and/or cystoscopy prior to the procedure can help obtain prostate
measurements to determine the appropriate number of treatments.
7. Estimate the prostatic treatment length (i.e. from bladder neck to verumontanum).
This length is considered the vapor treatment zone (Figure 13).
Figure 13. Prostatic Treatment Length.
8. Based on the length of the vapor treatment zone, determine the number of treatments
per lobe (Table 2). A treatment consists of a single 9-second delivery of vapor.
Table 2. Guidelines for determining the number of treatments (lateral lobe).
Distance from Bladder Neck
to Veru
< 2.0 cm
2.0 – 3.0 cm
> 3.0 cm
9. If a median lobe is present and judged to be in need of treatment, deliver one
treatment if median lobe is < 2 cm and two or more treatments if median lobe is
> 2 cm. If central zone hyperplasia contributes to an elevated bladder neck with
a prostatic urethral ≥ 35 degrees, as evidenced by sagittal TRUS, deliver one
treatment for an enlarged central zone < 2 cm and two treatments for an enlarged
central zone > 2 cm.
Caution: Treatments in excess of those recommended in the guidelines may lead to
prolonged irritative symptoms and/or catheterization.
Note: A maximum number of 15 full treatments can be delivered with each Delivery Device.
Bladder Neck
Verumontanum
Estimated Number of Treatments
per Lobe
1-2
2-3
3-4
Figure 14. Illustrative example of 6 Vapor Treatments.
Warning: Proper placement of the needle is essential. Do not direct the needle
downward toward the rectum.
10. Start the procedure by positioning the tip of the device just inside the bladder.
Rotate the Delivery Device 90 degrees (horizontal) and bring device shaft just off
floor of urethra.
11. While maintaining the 90 degree rotation, pull Delivery Device back into the urethra
and position 1 cm back from the bladder neck. If treatment occurs within 1 cm of
the bladder neck, short-term irritative symptoms may be experienced by the patient.
Place the distal tip of the Delivery Device shaft against the lateral urethral wall.
Note: Optimal placement for the vapor treatment is in the crest of the lateral lobe.
Ensure the shaft of the device is not close to the anterior surface, as this may lead to a
sub-optimal treatment.
Note: On occasion, patient prostatic anatomy may restrict the Delivery Device tip from
reaching the bladder neck. This may be due to an elevated bladder neck from central
zone hyperplasia or a median lobe. On these occasions, do not force the device
through tissue. Ensure the Delivery Device tip is proximal to the verumontanum and
treat the bulk of the lateral lobe proximal to the verumontanum. Advance the Delivery
Device in 1 cm increments toward the bladder neck to deliver subsequent vapor
treatments. This may relax the tissue to allow the Delivery Device to reach the bladder
neck. If the Delivery Device still cannot reach the bladder neck, treat the area that is
proximal to the verumontanum.
12. Stabilize the Delivery Device before deploying the needle and remain completely
still throughout the treatment.
13. While holding the Flush Activation Button, continue to pull in the Needle
Deployment Button until the needle is deployed.
14. Visually verify the needle is fully inserted into the prostate by inspecting to see that
the black depth marker just proximal to the emitter holes is not visible (no black
should be seen).
Warning: Do not start treatment if the black depth marker on the needle is still visible
after needle deployment. If the marker is still visible, push the needle deeper into the
prostate until no black is visible through the lens. If unable to position correctly, deliver
vapor for ~4 seconds to devascularize the site, then retract needle by pressing upward
on the Needle retraction Button. Reposition Delivery Device approximately 1 cm from
the partially treated site and repeat needle deployment steps.
15. Using finger, pull in Vapor Activation Button and hold to activate the vapor until
treatment cycle is complete.
Caution: Once needle is deployed, hold the Delivery Device steady. Movement of the
Delivery Device may stretch tissue and cause vapor to leak into the urethra, causing
urethral irritation. Extreme movement may also cause pressure on the needle resulting
in difficulty with needle retraction. Needle must be returned to the original insertion
position to facilitate retraction.
Note: When the vapor treatment begins, the Rezūm System automatically tracks the
time until the programmed treatment is complete and then automatically shuts off the
vapor. Vapor can be stopped prior to treatment completion if Vapor Activation Button
is released.
Caution: Do not release Vapor Activation Button during vapor treatment cycle. If
Vapor Activation Button is released before the cycle is complete, vapor release will
automatically stop, which may lead to partial and incomplete treatment.
16. The display screen will show each individual treatment time and count the number
of full treatments that were completed.
17. Release Vapor Activation button and push upward on the Needle Retraction Button
to retract the needle.
7
Black (K) ∆E ≤5.0