Instructions For Use - Entellus Medical XprESS Pro Gebrauchsanweisung

INSTRUCTIONS FOR USE

ALL INSTRUCTIONS, PRECAUTIONS AND WARNINGS SHOULD BE CAREFULLY READ AND
UNDERSTOOD BEFORE USE. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.
Caution – Federal (USA) law restricts this device to sale by or on the order of a physician.
Indication for Use
To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses
and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow
tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in
patients 18 years and older using a transnasal approach.
Description
The XprESS ENT Dilation System is intended to remodel or recreate the sinus outflow tract and dilate the
Eustachian tube by transnasal balloon dilation. The XprESS device combines features of a curved suction tip and
an ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable
a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. Since the
distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and Eustachian
tubes within the same patient.
Figure 1 – XprESS ENT Dilation Device
The XprESS device curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal
barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may
be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from
exiting the suction vent during irrigation. The XprESS ENT Dilation System is provided sterile and for single use only.
The XprESS ENT Dilation System includes the XprESS device, Inflation Syringe, Bending Tool, and an Extension
Line. The XprESS LoProfile and Ultra ENT Dilation Systems also include the PathAssist LED Light Fiber. The
XprESS Pro ENT Dilation System also includes a Tuohy Adapter.
XprESS is available in the following suction tip sizes and balloon sizes. All suction tips and balloon lengths are
appropriate for treating all sinuses and Eustachian tubes; selection is based on physician preference.
XprESS Pro XprESS LoProfile
LoProfile Suction Tip
Standard Suction Tip
(1.75mm ball tip, 0.7mm ID,
(2mm ball tip, 1mm ID, 1.5mm OD)
Balloon Diameter × Length (mm) Balloon Diameter × Length (mm) Balloon Diameter × Length (mm)
NA
NA
6 × 8
6 × 18
7 × 18
The XprESS ENT Dilation System has been tested to withstand multiple inflations and device tip manipulations
in a surgical case.
Contraindications
•
None known
Warnings
•
Never advance or withdraw the XprESS device against any resistance. Do not use excessive force or torque
to advance the XprESS device or balloon/slide assembly when positioned in any paranasal or nasopharynx
space. Such actions could lead to tissue trauma, bleeding, or device damage.
•
Do not use breached or damaged packages, since the sterility and functionality of the device may be compromised.
•
The XprESS ENT Dilation System is provided sterile and intended for single use only. Do not resterilize
and/or reuse, as it may result in compromised device performance and risk improper sterilization and
cross-contamination.
•
Do not use the XprESS device in patients with known allergies to barium sulfate.
•
Do not use XprESS to dilate Eustachian tubes in patients with a history of patulous Eustachian tubes.
•
Due to the variability of anatomy, review appropriate radiographic imaging (eg, a CT scan) prior to treatment. Do
not use the XprESS device to treat a hypoplastic/atelectatic maxillary sinus, atelectatic ethmoid infundibulum,
or patients with evidence of internal carotid artery dehiscence.
•
Due to the variability of sinus development in pediatric patients, review CT scan to assess each sinus's
development and appropriateness for balloon dilation. Pneumatizaton may occur as early as 1-2 years of age
and continues to develop throughout childhood. Do not use XprESS in a sinus that is not adequately developed.
•
Do not insert the XprESS device beyond the tubal isthmus of the Eustachian tube, as this may increase the
risk of bony fracture and injury to the internal carotid artery.
•
Do not advance the LED Light Fiber beyond the distal tip of XprESS when XprESS is placed in the Eustachian
tube, as this may lead to tissue trauma.
•
Do not exceed the maximum recommended balloon inflation pressure of 12 atm. Over-inflation of the balloon
can result in serious adverse events.
•
Do not use ionic or non-ionic fluoroscopic contrast solution to inflate the balloon in patients with known allergies
to contrast media.
•
If suction through the XprESS device lumen is used during the procedure, temporarily discontinue suction
(remove finger from suction vent, disconnect suction hose from device, or clamp suction hose) at the time of
balloon inflation. Suction can resume subsequent to balloon deflation. Using the XprESS device in suction
mode while balloon is inflated may result in barometric trauma to tissue, which may lead to increased bleeding
or damage to the tympanic membrane.
•
Do not irrigate within the Eustachian tube, as this may damage the tympanic membrane.
•
As in any upper airway procedure or sinus surgery, do not have patient use CPAP until the physician has
confirmed that the tissue is adequately healed. CPAP use prior to soft tissue healing may result in facial and/
or neck swelling due to subcutaneous emphysema.
•
Do not clean the XprESS device with anti-microbial agents as the compatibility of the XprESS device with
these agents has not been tested.
•
The XprESS device has been tested only with the Fiagon Navigation System. Do not attach the XprESS device
to other image guidance systems, as use with other systems may result in inaccurate device positioning. Refer
to System Operation 1.b for instructions on how to connect XprESS to the Fiagon system.
XprESS Ultra
Ultra Suction Tip
(1.5mm ball tip, 0.5mm ID,
1.2mm OD) 1.0mm OD)
5 × 8 5 × 8
5 × 20 5 × 20
6 × 8 6 × 8
6 × 20 6 × 20
7 × 20 NA
•
The XprESS device has been tested only with the Entellus Inflation Syringe. Do not use other inflation devices
with the XprESS device, as doing so may result in serious patient injury.
Precautions
○ Store the XprESS device components in a cool and dry place. Never use a device that is beyond its expiration date.
○ Handle the XprESS device with care. Prior to use, and during the procedure, inspect the packaging and
components for bends, kinks, or other damage. Discontinue the use of the XprESS device if it may have
been damaged.
○ Select a balloon diameter that will result in expansion of the tissue post dilation. Do not select a balloon diameter
that is larger than the bony margins of the outflow tract as this may damage the balloon.
○ Pay special attention when advancing or withdrawing the balloon and slide assembly. If resistance is encountered,
use endoscopy or direct visualization to help guide device out of the paranasal or nasopharynx space and then
attempt to alleviate the resistance. If the cause of resistance cannot be determined, do not use the XprESS device.
○ Use direct endoscope visualization with or without PathAssist LED Light Fiber or Light Fiber to ensure accurate
placement of the balloon prior to dilation. If balloon location cannot be verified, image guidance or fluoroscopy
can be used. If balloon location still cannot be verified, the balloon should not be inflated.
○ Consider using self-limiting radiation exposure equipment when employing fluoroscopy to confirm device
placement. Ensure the equipment is calibrated and maintained according to the equipment manufacturer's
user manual.
○ Use techniques for reducing fluoroscopic exposure when using fluoroscopy. Examples are applying pulsed
beam settings, increasing target-to-panel distance, using posterior-anterior projection, and using appropriate
lead shield protection. Total fluoroscopy time should be limited to 30 minutes.
○ When fluoroscopy is used, especially in children, minimize radiation dose to the lens of the eye and other
proliferating tissues due to the potential for cataract formation or injury to the surrounding tissue.
○ Do not advance or withdraw a guidewire through the XprESS Pro or LoProfile suction/irrigation lumen against
resistance. This could lead to device damage.
○ Be aware that guidewires (including Fiagon GuideWires) do not track through the XprESS Pro or LoProfile when
they are bent in the recommended maxillary configuration or through the XprESS Ultra in any configuration. Other
methods can be used to obtain confirmation of the treatment area, such as use of the PathAssist Light Fiber,
direct visualization of the XprESS device with an aid of an endoscope, or fluoroscopic imaging of the XprESS tip.
○ Use standard larger suction tubes for removal of thick secretions or other materials. XprESS Pro has a 1 mm
ID comparable to that of a 5F suction tube. XprESS LoProfile has a 0.7 mm ID comparable to that of a 4F
suction tube. XprESS Ultra has a 0.5 mm ID comparable to that of a 2.5F suction tube. All are capable of
removing blood and thin mucous.
○ Fully deflate the balloon and retract the balloon slide assembly before withdrawing the XprESS device from
the paranasal or nasopharynx space.
○ Use only liquid contrast or saline solution for inflation. Do not inflate with air.
○ Consider using a new balloon if cross-contamination between sinuses or Eustachian tubes is a concern.
Adverse Effects
Possible adverse effects include, but are not limited to, the following:
• Complication from anesthesia • Cavernous sinus syndrome
• Damage to the lamina papyracea • Damage to the lacrimal sac
affecting tearing
• Damage of the orbital wall or
other structures of the eye • Pneumocephalus
• Cerebrospinal fluid leak • Bruising and swelling
• Loss of vision or diplopia • Tissue inflammation
(double vision)
• Fever and infection
• Pain • Continued or
• Bleeding worsening symptoms
Supplies
The following supplies are not provided with the XprESS ENT Dilation System and should be available and
prepped prior to use of the device.
− Appropriate endoscopes and compatible camera system
− ≥50 mL of sterile saline solution, sterile fluoroscopic contrast solution, or sterile water
− Needles and syringes as required for injections
− 20-30 mL syringe and Extension Line (if irrigation is to be performed)
− Suction system
− Other supplies or medication as established by laboratory protocol
− If the use of a sterile guidewire is desired (compatible with the XprESS Pro), the recommended guidewire
should be sterile and ≤0.035 inches in diameter with a minimum length of 50 cm. Example of a guidewire that
meets these requirements is the Entellus Medical Sinus Guidewire.
− If desired, Entellus Medical PathAssist™ LED Light Fiber, Light Fiber™, or Light Seeker
Optional Equipment
− Fiagon Navigation System and GuideWires (GuideWire and GuideWire 0.6 are compatible with XprESS Pro;
GuideWire 0.6 is compatible with XprESS LoProfile)
− Fluoroscopy may be used in conjunction with the endoscope if desired.
− Refer to appropriate Instructions for Use and safety procedures when preparing and using equipment.
Instructions for Use
System Preparation
1. Prepare the Inflation Syringe and Extension Line
a. Remove the Inflation Syringe and Extension Line from its
sterile package.
Note the 3 referenced Inflation Syringe plunger positions:
3
• Revision surgery
• Tinnitus
• Damage to the Eustachian tube
• Patulous Eustachian tube
• Permanent hearing loss
• Carotid artery damage
• Tympanic membrane damage
Figure 2 - Plunger all the way in
Figure 3 - First Click position
Figure 4 - Second Click position
(all the way out)