Urolift UL400 User Manual
PRODUCT DESCRIPTION
The UroLift® System (UL400) is comprised of two main components:
UroLift Delivery Device and UroLift Implant.
RX ONLY.
CAUTION: Federal Law restricts this device to sale by or on the
UroLift® System UL400
Instructions for Use
Box Contents:
Catalog No. REF UL400-4 (4 Trays)
Tray Contents:
• 1 UroLift® System
• 1 UroLift® Handle Release Tool
Manufactured By:
NeoTract,® Inc.
4473 Willow Rd, Suite 100
Pleasanton, CA USA 94588
Tel: (925) 401-0700 • (877) 408-9628
Fax: (925) 401-0699
Email: customerservice@neotract.com
L00111-01 Rev B 01/2018 NeoTract® Instructions for Use, UroLift® System Page 1 of 4
order of a physician.
Device Dimensions
DIMENSION VALUE
Needle Diameter
Maximum Deployed
Needle Depth
Suture Component Diameter
STERILE. The UroLift® System has been sterilized using gamma
sterilization. For single-use only and must not be resterilized.
The UroLift System is inoperable after single use.
Not made with natural rubber latex.
WARNING: Do not use if package is opened or damaged. A non-sterile
device may result in patient infection.
STORAGE CONDITIONS:
Store device at room temperature.
INDICATIONS FOR USE
The UroLift System is indicated for the treatment of symptoms due to
urinary outow obstruction secondary to benign prostatic hyperplasia
(BPH), including lateral and median lobe hyperplasia, in men 45 years
of age or older.
CONTRAINDICATIONS
The UroLift System should not be used if the patient has:
• Prostate volume of >80 cc
• A urinary tract infection
• Urethra conditions that may prevent insertion of delivery system
into bladder
• Urinary incontinence due to incompetent sphincter
• Current gross hematuria
19 Gauge
(0.042 in.)
33 mm
(1.299 in.)
0.38 mm
(0.015 in.)
Figure 1
UroLift® Delivery Device
The UroLift Delivery Device (Figure 1) is designed to access the
prostatic urethra and deliver one UroLift Implant through the lobes
of the prostate.
Using the Delivery Device, the UroLift Implant is delivered in
4 basic steps:
• Needle Safety Lock (1) is released.
• Needle Trigger (2) is depressed, deploying the needle and
Capsular Tab to the capsular side of the prostate. The needle
extends 33 mm from the tip of the device.
• Retraction Lever (3) is retracted, resulting in delivery of the
Capsular Tab with suture under tension.
• Urethral Release (4) is pressed, deploying the Urethral End-Piece
and cutting excess suture.
The UroLift Delivery Device is then withdrawn. This process is intended
to increase the luminal prostatic urethral opening thereby relieving
lower urinary tract symptoms associated with BPH. On average, 4 to
6 UroLift Implants are typically placed per patient. The maximum
number recommended to be placed per patient is 10 UroLift Implants.
The UroLift Implant (Figure 2) consists of a Capsular Tab connected
by PET (Polyethylene Terephthalate) monolament suture to the
Urethral End-Piece.
Figure 2
UroLift® Implant
Treatment with the UroLift System does not preclude follow up
treatment with the UroLift System, transuretheral resection of the
prostate (TURP) or laser vaporization of the prostate. Retreatment
via other therapies has not been studied.
ACTIONS
The materials used in the UroLift Implant are well established for use
in medical device implants and elicit minimal acute inammatory
reaction in tissue. The UroLift Implant is not absorbed, nor is any
signicant change in tensile strength known to occur in vivo.
WARNINGS AND PRECAUTIONS
1. Read all instructions prior to using the UroLift System.
2. Do not use if patient has known allergy to nickel, titanium, or
stainless steel.
3. The UroLift System is intended for Single Patient Use Only – DO
NOT RESTERILIZE. Resterilization may result in device malfunction
including incomplete needle deployment or failed suture delivery
requiring further physician intervention. The UroLift System is
provided sterile. Sterility will be maintained only if package is
unopened and undamaged. The user should inspect packaging
integrity prior to use. If damage is detected or sterile packaging
compromised, user should not use the product and should return
it to NeoTract,® Inc.
4. Users should be familiar with performing sterile transurethral
surgical procedures and cystoscopic techniques. Patient should be
placed in balanced lithotomy position.
5. Training is required prior to using the UroLift System. Physician
and Sta Training Program entails a) a didactic session; b) clinical
video review; and c) hands-on device use. The program focuses
on patient selection, procedure preparation, device operation, and
implantation technique. Please contact NeoTract Customer Service
at (925) 401-0700 for UroLift System training information.
6. Store device at room temperature. Avoid exposure to prolonged
elevated temperatures.
7. After use, the device may be a potential biohazard and should
be handled accordingly. Dispose of device in accordance with
accepted medical practice and applicable local and federal laws
and regulations.
Note: Other relevant warnings and precautions are included with the
associated section or process step for emphasis as described below.
OPERATING INSTRUCTIONS
Read all instructions prior to using the UroLift System.
ANCILLARY EQUIPMENT
1. 2.9 mm 0° telescope (i.e. NeoTract REF UL-SCOPE or equivalent)
2. 20F sheath (i.e. NeoTract REF UL-SHEATH or equivalent)
3. Visual Obturator (i.e. NeoTract REF UL-VO or equivalent)
4. Cystoscopy camera, light box/cable and monitor
5. Standard uid irrigation system including new, sterile uid tubing
6. Standard endoscopic grasper kit
†
It is recommended to have a grasper kit (or an equivalent standard
urology instrument for foreign body retrieval) in the event that it is
desired or necessary to retrieve or remove part of the UroLift Implant
during the procedure.
All equipment compatibility should be veried prior to use.
The ancillary equipment, including the telescope, sheath, visual
obturator, bridge and graspers must be sterilizable per the respective
manufacturer’s instructions and should be sterilized prior to use.
†
OPERATING INSTRUCTIONS
HANDLING COMPONENTS
Care must be taken to avoid mishandling components. Users should
be cautious when handling components to avoid inadvertent
punctures. When surgical instruments and accessories from
different manufacturers are employed together, first ascertain
their compatibility prior to commencing with the procedure.
1. PREPARATION
1.1. Read and thoroughly understand all instructions.
1.2. Conrm that packaging components are unopened
and undamaged.
WARNING: Do not use if package is damaged or opened.
1.3. Inspect all components for any damage that may have occurred
during shipment or other handling.
CAUTION: Do not use if device is damaged.
1.4. While holding the handle end (heavy end) of tray, peel back the
cover to access the sterile contents.
1.5. Remove lid of tray using sterile technique.
WARNING: Failure to maintain the sterility of the UroLift® System
and ancillary equipment could lead to infection.
1.6. Remove device from packaging using sterile technique by lifting
device from tray by grasping handle.
CAUTION: Do not lift device by the steel shaft.
1.7. Inspect device tip and conrm that needle is not visible.
Inspect Needle Safety Lock and conrm that it is in the locked
(forward) position.
CAUTION: Do not use if the Needle is exposed or Safety Lock is in
the unlocked (rear) position.
2. DEVICE POSITIONING: LATERAL LOBES
CAUTION: Avoid placing pressure on the camera head to position
the UroLift Delivery Device. Image should be round on the video
monitor. A dark crescent or a portion of image missing is evidence
of excessive load on the camera head. Excess pressure could
compromise device performance or damage telescope.
2.1. Assemble the 2.9 mm 0° telescope (NeoTract REF UL-SCOPE or
equivalent), visual obturator, and 20F sheath.
2.2. Insert the telescope assembly in the urethra and visualize the
urethra and bladder by advancing it through the urethra and into
the bladder.
2.3. Remove the telescope and bridge/visual obturator, leaving the
sheath in the bladder.
2.4. To install the telescope, insert 2.9 mm 0° telescope (NeoTract REF
UL-SCOPE or equivalent) into device with the telescope lightpost
at 12 o’clock. Keep forward pressure on the telescope, hold
telescope lightpost at 12 o’clock and secure the scope lock by
rotating clockwise until nger tight. Do not overtighten.
CAUTION: Overtightening the scope lock may result in damage to
the UroLift Delivery Device.
2.5. Insert the UroLift Delivery Device (with 2.9 mm telescope
installed) into the sheath and lock the sheath lock.
2.6. When treating the prostate lateral lobes, to avoid external
prostatic structures (e.g. neurovascular bundle), UroLift Implants
should be implanted in the anterior aspect of the prostate, in
between the 2-3 and 9-10 o’clock positions (Figure 3).
WARNING: Failure to deploy the implant as described above
could lead to nerve damage, bleeding, pain, infection, damage
to the gastrointestinal tract or stula formation.
1:0011:00
10:00
9:00
2:00
3:00
Figure 3
Prostatic schematic –
placement of
UroLift® Implants
2.7. Pre-determine treatment site by orienting the Delivery Device
tip in a lateral direction, typically about 2-3 o’clock or 9-10
o’clock, (Figure 3) in the bladder then slowly moving the device
distally to visualize the prostatic fossa from the bladder neck to
the verumontanum.
Delivery Device tip should be approximately 1.5 cm distal from
the bladder neck for delivery of the most proximal implant.
As with cystoscopy, keep device parallel to prostatic fossa and
avoid excessive instrument movement throughout positioning
and deployment.
Note: The needle deployment direction is in line with the
Delivery Device handle.
CAUTION: Deploying too close (<1 cm) to the bladder neck
may result in implants that are exposed to the bladder vesicle.
Improperly placed implants could lead to encrustation and may
need to be removed.
2.8. Position the UroLift Delivery Device such that the Deployment
Target (Figure 4) is against the target prostatic lobe in the
lateral direction.
Deployment
Target
Cystoscopic view of Delivery Device
2-3 o’clock position in this image.
Figure 4
tip showing Deployment Target,
needle will Extend/Deploy in the
2.9. To achieve desired amount of urethral opening, angle Delivery
Device laterally (pivot about external urinary sphincter),
applying slight pressure to the Delivery Device tip via
Delivery Device handle.
WARNING: Do not use the cystoscopy camera head to apply
pressure to the prostate tissue as this could compromise UroLift
System performance.
WARNING: To avoid inadvertent needle advancement, do not
place nger on Needle Trigger when positioning Delivery Device
once Needle Safety Lock is unlocked.
3. IMPLANT DEPLOYMENT
While holding the UroLift Delivery Device distal tip stable against
the target tissue:
3.1. Unlock the Needle Safety Lock (Step 1, Figure 5).
3.2. Lightly depress the Needle Trigger to deploy the needle (Step 2,
Figure 5), then release the Needle Trigger. The UroLift System
needle extends 33 mm, which is sucient to reliably access
the prostatic capsule based on cadaver and clinical studies. The
Capsular Tab is delivered from the tip of the extended needle and
is tensioned back towards the prostatic capsule until it seats on
the capsular surface.
CAUTION: Do not pull on the Retraction Lever during the Needle
Trigger pull.
Figure 5
UroLift® Delivery Device
3.3. After a brief pause, depress the Retraction Lever (Step 3, Figure 5)
fully to retract needle and deploy Capsular Tab. Squeeze the
Retraction Lever again to ensure completion of retract stroke.
3.4. Depress the Retraction Lever completely until it locks into the
handle. Once the Retraction Lever is locked into the handle, the
Needle is in the retracted (not exposed) position and is contained
within the Delivery Device.
CAUTION: Failure to pull the Retraction Lever completely may
result in needle redeployment, Urethral End-Piece misdeployment,
loose Urethral End-Piece, or incomplete suture cut.
CAUTION: Avoid contact with the Urethral Release button
when pulling the Retraction Lever. Contact with the Urethral
Release button while pulling the Retraction Lever may result
in inadvertent deployment of the Urethral End-piece and
unintentionally cutting the suture.
3.5. Release the Retraction Lever and release the compression
applied to the Prostatic lobe.
Suture tension is now maintained by the Delivery Device. The
suture will be against the edge of the keyhole that is closest in
the cystoscope view (Figure 6).
Figure 6
Image of Delivery Device
tip showing suture against
closest edge of keyhole.
3.6. If the suture is not against the closest edge of the keyhole, slowly
move the device proximally toward the bladder to get the suture
against the closest edge of the keyhole. Often the suture becomes
visibly brighter in color, showing reection of the cystoscopy light.
CAUTION: Failure to position suture against closest edge
of keyhole (Figure 7) may result in Urethral End-Piece
misdeployment or incomplete suture cut.
Figure 7
Image of Delivery Device tip
showing suture not against
closest edge of keyhole .
L00111-01 Rev B 01/2018 NeoTract® Instructions for Use, UroLift® System Page 2 of 4
Loading...