AIRvance System

AIRvance System – Tongue Suspension Procedure

Description

The AIRvance™ Tongue Suspension procedure is designed for anterior tongue base suspension by fixation of soft tissue of the tonue base to the mandible using a bone screw with integrated suture. The AIRvance Tongue and Hyoid Suspension consists of:

• The G2 AIRvance Bone Screw - A miniature, self-tapping screw attached to No. 1 polypropylene suture. The bone screw has a diameter of 2.9 mm and is 5.5 mm in length
• The AIRvance Bone Screw Inserter - A battery-operated, disposable device which deploys the screw
• The AIRvance Suture Passer - This device facilitates the passing of the suture through the tongue.
• The AIRvance Tongue Retractor - This device facilitates retraction of the tongue while passing and retrieving sutures through the tongue base.

Indications

The AIRvance Bone Screw System is intended for anterior tongue base suspension by the fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. The AIRvance Bone Screw System is also suitable for the performance of a hyoid suspension procedure which can be used in combination with other procedures for the treatment of obstructive sleep apnea (OSA). It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.

Warnings

1. Do not use if package is open or damaged.
2. The optimal advancement of the posterior tongue base should be between 0.5-1.0 cm. Over advancement may lead to tongue edema and post procedure pain.
3. Do not reuse.
4. Verification that the knot is completely buried in the muscle must be performed.

Contraindications

Contraindications associated with the AIRvance Tongue Suspension procedure include:

1. Primary palatal level of obstruction (Friedman Stage 1)
2. Marked macroglossia and severe tongue grooving based on oropharyngeal endoscopy
3. Abnormalities of the mandibular bone, severe periodontitis or poor oral hygiene.
4. History of myocardial infarction, stroke, congestive heart failure or central sleep apnea.
5. Blood coagulation disorders.
6. General anesthesia contraindications.
7. Prior head and neck radiation therapy.
8. Root canal dentistry for midline mandibular incisors

Precautions

1. The AIRvance Tongue Suspension should be performed by trained physicians only.
2. The sterile packaging of the AIRvance Bone Screw Kit and/or Screw should be inspected for visible damage prior to use. Do not use if damage is evident or suspected.
3. The AIRvance Bone Screw System has not been evaluated for safety and compatibility in the MR environment. The AIRvance Bone Screw System has not been tested for heating or migration in the MR environment.

Note: Ensure that the screw is seated firmly in the inserter ratchet head prior to placing in incision and driving the screw into the mandible. If not firmly seated, move switch to “Ready” and pull on suture tail until screw seats in inserter ratchet head then return to “Safe” and continue with normal implantation steps.

Complications

Complications associated with AIRvance Tongue Suspension include those associated with other tongue base suspension and advancement methods. These risks include: infection, tongue edema, osteomyelitis, and neurovascular damage due to penetration of the suture passer through the lateral tongue base. Wharton’s duct and sublingual salivary gland damage (intraoral approach), damage to the teeth roots due to incorrect screw placement, relapse or over-correction of the tongue due to incorrect tightening of the sutures, muffled speech and suture breakage.

Sterility

The AIRvance Tongue Suspension Kit and/or G2 AIRvance BoneScrew is supplied sterile (EtO) for single patient use only.

AIRvance System – Hyoid Suspension Procedure

Description

The AIRvance™ Tongue and Hyoid Suspension procedure is designed for hyoid myotomy and suspension to the mandible, utilizing two bone screws with integrated suture. The AIRvance Hyoid Myotomy and Suspension procedure requires two (2) G2 AIRvance Bone Screws and hyoid needle.

Indications

The AIRvance Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. The AIRvance Bone Screw System is also suitable for the performance of a hyoid suspension procedure which can be used in combination with other procedures for the treatment of obstructive sleep apnea (OSA) and/or snoring.

Warnings

1. Do not use if package is open or damaged.
2. Do not reuse.

Contraindications

1. Post radiation to the head and neck.
2. Abnormalities of the mandibular bone, severe periodontitis.
3. History of myocardial infarction, stroke, congestive heart failure or central sleep apnea, i.e., severe anesthetic risk.
4. Blood coagulation disorders.
5. Site of obstruction other than tongue base or hypopharynx.
6. Compromised immune system.
7. Prior mandible fractures.

Precautions

1. The AIRvance Tongue and Hyoid Suspension should be used by trained physicians only.
2. The sterile packaging of the AIRvance Tongue and Hyoid Suspension should be inspected for visible damage prior to use. Do not use if damage is evident or suspected.
3. The physician is advised against using extreme traction when repositioning the hyoid to prevent the possibility of suture breakage.
4. The AIRvance Bone Screw System has not been evaluated for safety and compatibility in the MR environment. The AIRvance Bone Screw System has not been tested for heating or migration in the MR environment.

Note: Ensure that the screw is seated firmly in the inserter ratchet head prior to placing in incision and driving the screw into the mandible. If not firmly seated, move switch to “Ready” and pull on suture tail until screw seats in inserter ratchet head then return to “Safe” and continue with normal implantation steps.

Complications

Complications associated with the AIRvance Hyoid Suspension procedure include those associated with other hyoid suspension procedures to either the mandible or thyroid cartilage. These risks include: infection, osteomyelitis, swallowing difficulty due to over-advancement of the hyoid bone and associated muscle, bone and suture breakage.

Sterility

Both the AIRvance Tongue and Hyoid Suspension and the G2 AIRvance Bone Screw are supplied sterile (EtO) for single patient use only.

*As of August 2011, the Repose^® brand was changed to the AIRvance.™