ENT risk and safety information for patients

Audion® ET dilation system device

The Audion ET Dilation System is intended to dilate the cartilaginous portion of the Eustachian Tube in patients with symptoms of Eustachian tube dysfunction (ETD).

Any medical procedure carries certain risks. Discuss the possible complications and risks of the Audion ET dilation treatment with your doctor as they will vary based upon your medical condition. 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. Talk to your doctor for a full list of risk, warnings and safety information.

The information presented is for educational purposes only. Speak to your doctor to decide what course of treatment is right for you. 

Individual results vary and not all patients will experience symptom relief. 

It is important to follow your doctor’s instructions regarding pre- and post-procedural care.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 

ClariFix® cryotherapy device

ClariFix is intended for adults with chronic rhinitis.

Any medical procedure carries certain risks. Discuss the possible complications and risks of the ClariFix treatment with your doctor as they will vary based upon your medical condition. The most common side effects associated with the ClariFix treatment include 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 if you have a clotting disorder, uncontrolled high blood pressure, or use anticoagulants or blood thinners. Talk to your doctor for a full list of risk, warnings and safety information.

The information presented is for educational purposes only. Speak to your doctor to decide what course of treatment is right for you. 

Individual results vary and not all patients will experience symptom relief.

It is important to follow your doctor’s instructions regarding pre- and post-procedural care.

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 should not be used if you have a known or suspected allery to polylactic acid (PLA) or if you have an infection near the implant site.

Any medical procedure carries certain risks. Discuss the possible complications and risks of LATERA with your doctor as they will vary based upon your medical condition. The most common side effects associated with LATERA include pain or discomfort, bruising at the implant site, and minor cosmetic changes. Other risks related to the LATERA implant include infection, reaction to material, and surgical implant removal. LATERA implants placed near the skin surface may be noticeable by touch and/or cause skin irritation.

Excessive activity or trauma may cause the implant to bend, break, or migrate. Talk to your doctor for a full list of risk, warnings and safety information.

The information presented is for educational purposes only. Speak to your doctor to decide what course of treatment is right for you. 

Individual results vary and not all patients will experience symptom relief. 

It is important to follow your doctor’s instructions regarding pre- and post-procedural care.

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 is intended to use balloon dilation to remodel or recreate the sinus outflow tract in patients with chronic rhinosinusitis and dilate the cartilaginous portion of the Eustachian Tube in patients with symptoms of Eustachian tube dysfunction (ETD). 

Any medical procedure carries certain risks. Discuss the possible complications and risks of the XprESS dilation treatment with your doctor as they will vary based upon your medical condition. 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. Talk to your doctor for a full list of risk, warnings and safety information.

The information presented is for educational purposes only. Speak to your doctor to decide what course of treatment is right for you. 

Individual results vary and not all patients will experience symptom relief. 

It is important to follow your doctor’s instructions regarding pre- and post-procedural care.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.