ENT risk and safety information for health care professionals
Audion® ET dilation system device
The Audion ET dilation system Indications for Use: 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.
A physician using Audion for Eustachian tube dilation must either have: (i) experience with a Eustachian tube balloon dilation device or (ii) undergone cadaver training on the use of a balloon dilation device for Eustachian tube dilation. If a physician who intends to use Audion for Eustachian tube dilation does not meet at least one of these criteria, please contact your Stryker representative to arrange training.
The most common side effects associated with the use of Audion for Eustachian Tube dilation include: pain, tissue inflammation, damage to the Eustachian Tube and continued or worsening symptoms. Potential severe risks include: subcutaneous emphysema and carotid artery damage.
Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
ClariFix® cryotherapy device
ClariFix Indications for Use: The ClariFix device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
Most common side effects associated with the ClariFix treatment are temporary increased congestion and transient pain or discomfort, including headache. Potential severe risks include bleeding, septal perforation, dry eye, optical changes or orbital damage.
Nosebleeds may be increased in patients with a clotting disorder, uncontrolled high blood pressure, or those who use anticoagulants or blood thinners.
Please see the Instructions for Use for a complete list of warnings, precautions and adverse events.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Cliq suction pump
Cliq suction pump Indications for Use: The Cliq AS-1001D Suction Pump’s intended use is to remove bodily fluids from a patient’s airway or respiratory system. Using this device for any purpose other than the stated intended use may result in injury to the patient or operator.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Cyclone® sinonasal suction and irrigation system
Cyclone sinonasal suction and irrigation system Indications for Use: To provide a means to irrigate and suction within sinonasal spaces.
The most common side effect associated with the use of Cyclone sinonasal suction and irrigation system is tissue inflammation or trauma. Potential severe risks include orbital complications and cerebrospinal fluid leak.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events.
Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician
Entellus Medical shaver system
Entellus Medical shaver system Indications for Use: The Entellus Medical shaver system has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
ESSx microdebrider
ESSx microdebrider Indications for Use: For use with the Stryker Consolidated Operating Room Equipment (CORE) system software revision 6.1 or higher. The handpiece is designed for use in endoscopic or open plastic, reconstructive, and aesthetic surgery of the head and neck.
FocESS® image solutions
FocESS HD wireless camera Indications for Use: The FocESS HD wireless camera is indicated for use in endoscopic procedures to allow visualization of the nasal and sinus cavities when used with an appropriately indicated endoscope.
The FocESS HD wireless camera is intended for use in a physician’s office during endoscopic sinus examinations and procedures. The wireless camera is not intended for used in a sterile field.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
FocESS® sinuscopes
FocESS sinuscope Indications for Use: The FocESS sinuscope if intended to provide the physician with a means for endoscopic diagnostic and therapeutic sinus surgical procedures. The sinuscope is indicated for use in, but not limited to, such procedures as examination of sinus passages and cavities, and removal of abnormal growths such as polyps and facio-plastic surgery.
FoCESS sinuscope sterilization tray Indications for Use: The FocESS sinuscope sterilization tray is used to organize and protect the FocESS sinuscopes that are sterilized by a healthcare provider. The FocESS sinuscope sterilization tray is intended to allow sterilization of the enclosed medical devices during these sterilization cycles: pre-vacuum steam, STERRAD 100S Standard, STERRAD 100NX Standard, ethylene oxide, STERRAD NX Standard, STERRAD 100NX Express. The tray is intended to be used in conjunction with a legally marketed wrap. The tray is not intended on its own to maintain sterility.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
HemoPore® hemostatic bioresorbable nasal packing
HemoPore fragmentable nasal dressing Indications for Use: HemoPore is intended for use in patients undergoing nasal/sinus surgery as a temporary wound dressing. HemoPore functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation. It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema. HemoPore is indicated for use as a nasal packing to treat epistaxis.
The dressing is a biodegradable, polyurethane foam that fragments within several days. The nasal dressing drains from the nasal cavity via natural mucus flow and/or irrigation.
HemoPore fragmentable nasal dressing contraindications: HemoPore should not be used on patients who have known or suspected allergies to shellfish.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
LATERA® absorbable nasal implant system
LATERA system Indications for Use: The LATERA absorbable nasal implant system is indicated for supporting upper and lower lateral nasal cartilage.
LATERA is contraindicated in patients with an active infection at the implant site and patients who have or are suspected of having allergy to PLA or absorbable materials.
Improper patient selection, surgical site preparation, or implantation may potentially cause device failure and/or adverse reactions which could require implant removal. Adverse reactions to surgically implanted materials may occur. These include:
- Inflammatory foreign body reaction, foreign body sensation, pain or discomfort, infection, minor cosmetic changes, and extrusion
- Excessive activity, trauma, or loading may lead to bending, breaking, loosening, and/or migration of the implant.
- Implants placed near the skin surface may be palpable or cause skin irritation.
- Temporary hemotoma from cannula insertion.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® Blakesley forceps
MiniFESS forceps Indications for Use: The MiniFESS forceps are reusable, stainless steel instruments used to grasp, manipulate, compress or extract tissue in the nasal or sinus cavity.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® Blakesley thru-cut forceps
MiniFESS forceps Indications for Use: The MiniFESS forceps are reusable, stainless steel instruments used to grasp, manipulate, compress or extract tissue in the nasal or sinus cavity.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® portable red LED light source
Portable red LED light source Indication for Use: The Portable red LED light source is indicated for use in endoscopic procedures to locate, illuminate within and transilluminate across nasal and sinus structures when used with the MiniFESS Light Seeker.
The Portable red LED light source is intended for use in a physician’s office during endoscopic procedures. The Portable red LED light source is not intended for use in the sterile field.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® maxillary seekers
MiniFESS maxillary seeker Indications for Use: The MiniFESS maxillary seeker is a reusable, stainless steel instrument used to probe within the sinuses using a trans-nasal approach.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® sickle knife
MiniFESS sickle knife Indications for Use: The MiniFESS sickle knife is a reusable, stainless steel instrument used to cut tissue in the nasal or sinus cavity.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® sphenoid seeker/freer
MiniFESS sphenoid seeker/freer Indications for Use: The MiniFESS sphenoid seeker/freer is a reusable, stainless steel instrument used to probe and create space within the sinuses using a trans-nasal approach.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® light seeker
MiniFESS Light Seeker Indications for Use: The Light Seeker is intended to locate, illuminate within and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® sterilization tray
MiniFESS sterilization tray Indications for Use: The MiniFESS sterilization tray is used to organize and protect the MiniFESS instruments that are sterilized by a healthcare provider. The MiniFESS sterilization tray is intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle.
The tray is intended to be used in conjunction with a legally marketed wrap. The tray is not intended on its own to maintain sterility.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® Takahashi forceps
MiniFESS forceps Indications for Use: The MiniFESS forceps are reusable, stainless steel instruments used to grasp, manipulate, compress or extract tissue in the nasal or sinus cavity.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® turbinate forceps
MiniFESS forceps Indications for Use: The MiniFESS forceps are reusable, stainless steel instruments used to grasp, manipulate, compress or extract tissue in the nasal or sinus cavity.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
MiniFESS® Surgical Instruments
MiniFESS surgical instruments Indications for Use: The MiniFESS surgical instruments are reusable, stainless steel devices used to grasp, manipulate, extract or cut tissue in the nasal or sinus cavity.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events as well as cleaning, sterilizing and care for surgical instruments.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Fragmentable dressings
NasoPore® FD Nasal Dressing Indications for Use: NasoPore FD Nasal dressing is intended for use in patients undergoing nasal/sinus surgery as a temporary wound dressing. It controls minimal bleeding by tamponade effect and blood absorption.
NasoPore FD is intended to act as an adjunct to aid in the natural healing process by providing tissue support, minimizing edema and prevention of adhesion formation between mucosal surfaces.
Warning: Nasopore FD is intended for single-use only. DO NOT re-sterilize and/or reuse, as this can potentially result in compromised device performance and increased risk of inappropriate re-sterilization or cross contamination. Use the device prior to the “use by” specified on the package. This product is manufactured in a facility that also processes modified materials originating from crustaceans.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
NasoPore Indications for Use: Nasopore Nasal dressing is intended for use in patients undergoing nasal/sinus surgery as a temporary wound dressing. It controls minimal bleeding by tamponade effect and blood absorption.
Nasopore is intended to act as an adjunct to aid in the natural healing process by providing tissue support, minimizing edema and prevention of adhesion formation between mucosal surfaces.
Warning: NasoPore is intended for single-use only. DO NOT re-sterilize and/or reuse, as this can potentially result in compromised device performance and increased risk of inappropriate re-sterilization or cross contamination. Use the device prior to the “use by” specified on the package.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
OtoPore® Indications for Use: Ootopore is intended for single-use as a means of a temporary wound dressing in the outer ear after ear surgery.
Warning: OtoPore is intended for single-use only. DO NOT re-sterilize and/or reuse, as this can potentially result in compromised device performance and increased risk of inappropriate re-sterilization or cross contamination. Use the device prior to the “use by” specified on the package.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Reinforced anesthesia needle
Reinforced anesthesia needle Indications for Use: For use in injecting local anesthetics into a patient to provide regional anesthesia.
The most common side effects associated with the use of the Reinforced Anesthesia Needle are complications from anesthetic solution and tissue inflammation, irritation, swelling or trauma. Potential severe risks include orbital damage.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events.
Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.
Stryker ENT navigation system
Stryker ENT navigation system Indications for Use: The Stryker ENT Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to the following ENT procedures:
- Transsphenoidal access procedures;
- Intranasal procedures;
- Sinus procedures, such as maxillary antrostomies, ethmoidectomies,
- sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;
- ENT related anterior skull-based procedures
Please see Instructions for Use (IFU) for a complete listing of warnings and precautions. For the intended use of the individual products included in the system, refer to their specific manuals.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
TGS® Guidewire
TGS Guidewire Indications for Use: The TGS Guidewire is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for use with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System during balloon sinus dilation procedures.
TGS guidewire Indications for Use: The TGS Guidewire is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT- or MR- based model of the anatomy.
Example procedures include, but are not limited to:
- Transsphenoidal access procedures
- Intranasal procedures
- Sinus procedures, such as maxillary antrostomies, ethmoidectomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies
- ENT-related anterior skull base procedures
Please see Instructions for Use (IFU) for a complete listing of warnings and precautions.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
XeroGel® nasal/epistaxis pack
XeroGel nasal/epistaxis pack Indications for Use: XeroGel dressing is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying packing to:
- separate tissue or structures compromised by surgical trauma
- separate and prevent adhesions between mucosal surfaces; including during mesothelialcell regeneration in the nasal cavity
- help control minimal bleeding following surgery or trauma
- help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation
- act as an adjunct to aid in the natural healing process
XeroGel dressing is indicated for use as a nasal packing to treat epistaxis.
XeroGel dressing Contraindications: This product is contraindicated for use in patients with a known or suspected hypersensitivity/allergy to shellfish.
The most common side effects associated with the use of XeroGel include infection and scarring/synechia. A potential rare and severe risk includes toxic shock syndrome.
Please see Instructions for Use (IFU) for a complete listing of warnings, precautions and adverse events.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
XprESS® ENT dilation system
The XprESS ENT dilation system Indications 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.
A physician using XprESS for Eustachian tube dilation must either have: (i) experience with a Eustachian tube balloon dilation device or (ii) undergone cadaver training on the use of a balloon dilation device for Eustachian tube dilation. If a physician who intends to use XprESS for Eustachian tube dilation does not meet at least one of these criteria, please contact your Stryker representative to arrange training.
The most common side effects associated with the use of XprESS for sinus dilation include: pain, bleeding, tissue inflammation and continued or worsening symptoms. Potential severe risks include orbital complications and cerebrospinal fluid leak. The most common side effects associated with the use of XprESS for Eustachian Tube dilation include: pain, tissue inflammation, damage to the Eustachian Tube and continued or worsening symptoms. Potential severe risks include: subcutaneous emphysema and carotid artery damage.
PathAssist® LED Light Fiber Indications for Use: To locate, illuminate within, and transilluminate across nasal and sinus structures.
The most common side effect associated with the use of the LED Light Fiber is tissue inflammation or trauma. Potential severe risks include orbital complications and cerebrospinal fluid leak.
Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. We do not dispense medical advice and recommend that surgeons be trained in the use of any particular product before using it in surgery.
The information presented is intended to demonstrate Stryker’s products. A surgeon must always refer to the package insert, product label and/or instructions for use, including the instructions for cleaning and sterilization (if applicable), before using any of Stryker’s products. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your representative if you have questions about the availability of Stryker’s products in your area.
Stryker or its affiliated entities own, use, or have applied for the following trademarks or service marks: Audion, ClariFix, Cyclone, FocESS, HemoPore, LATERA, MiniFESS, NasoPore, OtoPore, PathAssist, Stryker, TGS, XeroGel, XprESS. All other trademarks are trademarks of their respective owners or holders.
The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark or other intellectual property rights concerning that name or logo.
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