NeoTract UroLift System UL400 Instructions For Use

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.
4155 Hopyard Road
Pleasanton, CA 94588 USA
Tel: 877.408.9628, +1 925.401.0700
Fax: +1 925.401.0699
Email: uroliftcustomer@teleflex.com
L00136-01 Rev A 03/2019
Device Dimensions
DIMENSION VALUE
19 Gauge
Needle Diameter
(0.042 in.)
Maximum Deployed 33 mm
Needle Depth (1.299 in.)
0.38 mm
Suture Component Diameter
(0.015 in.)
S
TERILE. 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 outflow 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
NeoTract® Instructions for Use, UroLift® System
PRODUCT DESCRIPTION
The UroLift System (UL400) is comprised of two main components:
UroLift Delivery Device and UroLift Implant.
Figure 1
UroLift® Delivery Device
The Delivery Device (Figure 1) is designed to access the prostatic
urethra and deliver one implant through the lobes of the prostate.
Using the Delivery Device, the 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 depressed, 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The Delivery Device is then withdrawn.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 implants are typically placed per patient. The maximum number
recommended to be placed per patient is 10 implants.
The implant (Figure 2) consists of a Capsular Tab connected by
monofilament 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.
The materials used in the implant are well established for use in
medical device implants and elicit minimal acute inflammatory
reaction in tissue. The suture is made from PET (Polyethylene
Terephthalate), the Capsular Tab is made from nitinol (nickel titanium
alloy), and the Urethral End Piece is made from stainless steel. The
implant is not absorbed, nor is any significant change in tensile
strength known to occur in vivo.
WARNINGS AND PRECAUTIONS
•
Read all instructions prior to using the UroLift System.
•
Do not use if patient has known allergy to nickel, titanium, or
stainless steel.
•
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 implant 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.
•
Users should be familiar with performing sterile transurethral
surgical procedures and cystoscopic techniques. Patient should be
placed in balanced lithotomy position.
•
Training is required prior to using the UroLift System. Physician
and Staff 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.
•
Store device at room temperature. Avoid exposure to prolonged
elevated temperatures.
•
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
•
2.9 mm 0° telescope (i.e. NeoTract REF UL-SCOPE or equivalent)
•
20F sheath (i.e. NeoTract REF UL-SHEATH or equivalent)
•
Visual Obturator (i.e. NeoTract REF UL-VO or equivalent)
•
Cystoscopy camera, light box/cable and monitor
•
Standard fluid irrigation system including new, sterile fluid tubing
•
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 implant during
the procedure.
All equipment compatibility should be verified prior to use.
The ancillary equipment, including the telescope, sheath, visual
obturator, and grasper kit must be sterilizable per the respective
manufacturer's instructions and should be sterilized prior to use.
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