Question about the THS System and Repose Procedure from Medtronic

Answers to Common Questions About the AIRvance THS System

What is the AIRvance THS System?

The AIRvance THS System includes an implanting device, tiny titanium screws, and sutures that are used to keep the tongue from falling back during sleep, which may result in obstructive sleep apnea. The AIRvance THS System is an effective therapy that can deliver sustained relief and improvement in quality of life from obstructive sleep apnea.

There are two procedures that are possible with the AIRvance THS System. The tongue suspension procedure uses a hammock-like suture to help keep the tongue from falling back into the airway while you sleep. The hyoid suspension procedure shifts the hyoid bone (which is at the base of the tongue) to move the space behind the tongue slightly forward. This increases the airway behind the tongue. Your doctor will decide if you only require the tongue suspension, or both the tongue and hyoid suspension.

Is the AIRvance THS System approved by the U.S. Food and Drug Administration (FDA)?

Yes. The Medtronic REPOSE THS System was cleared by the FDA in 1998 (under the name “Repose GAHM procedure”) following a clinical study with a two-year follow-up. As of August 2011 the Repose brand was changed to AIRvance.

How many AIRvance THS System procedures have been performed?

More than 15,000 AIRvance THS procedures have been performed worldwide.

Where is the AIRvance THS suture implanted?

Titanium screws and sutures are implanted on the lower inside portion of the chin. Sutures running from this fixed point support the tongue and hyoid bone, opening the airway and keeping the tongue from falling back.

How effective is the AIRvance THS System for sleep apnea relief?

The AIRvance THS system is effective at reducing your Apnea Index — by as much as 73%, according to a clinical study.1 A reduced Apnea Index means you are breathing more and getting more oxygen into your system. Patients who have had the procedure have reported significant improvements in daytime sleepiness.2

Can the AIRvance THS System be reversed?

Yes. While the AIRvance THS implant is designed to be permanent, a surgeon can easily cut the supporting sutures, effectively reversing the procedure. Typically, this can be done as an in-office procedure.

How does the AIRvance THS System compare with traditional MMA or GA surgery?

The AIRvance THS System is less invasive. The AIRvance THS procedure is an alternative to more invasive traditional surgery such as a maxillomandibular advancement (MMA), which moves the jaw top (maxilla) and bottom (mandible) forward or the genioglossus advancement (GA) procedure, which cuts out a window of bone on the lower side of your chin and then re-fixed to the jaw to move the tongue muscle forward.

The AIRvance THS procedure does not require complex bone removal or jaw repositioning, nor does it typically change your facial profile. Recovery time is short as a result.

Why does palate surgery (UPPP) alone generally fail?

For years doctors routinely performed a palate surgery call uvulopalatopharyngoplasty, or UPPP, and sometimes nasal surgery to treat obstructive sleep apnea. But studies following UPPP-only patients uniformly revealed a 40 to 50% cure rate for patients suffering from obstructive sleep apnea.3

The reason for this low success rate is the majority of obstructive sleep apnea patients suffer from multi-level obstruction (i.e., palate, tongue, upper airway, and nose). For the average person afflicted with obstructive sleep apnea, UPPP and nasal surgery alone is rarely enough to significantly reduce their risk or relieve their symptoms.4

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