Deutsch English Alaxo  
         

     
  AlaxoLito Nasal Stent
SLEEP APNEA/SNORING
AlaxoStent
PATIENT EXPERIENCE
SERVICE
DISTRIBUTORS
ABOUT US
Imprint
Disclaimer
Data protection
 
       

The AlaxoStent

     

The AlaxoStent is a medical device for treatment of obstructive sleep apnea (OSA) and snoring that the patient can insert into his nose and throat at night and remove in the morning.

Complementing conventional therapy of OSA the AlaxoStent offers a new non-surgical and therapeutically efficient treatment which provides numerous advantages in handling and increased convenience to the patients. The stent is a smooth tubular braid made from a so-called shape memory metal (nitinol). The nitinol braid [1] is compressed in a thin tube [2] (see Fig. 1) before introduction into one nostril. This tube is slowly introduced through one nasal passage to the throat (see video below).

AlaxoStent

Fig. 1: The two major AlaxoStent components: [1] nitinol braid, [2] introduction tube


When released from this tube, the nitinol braid self-expands and attaches to the wall of the throat. Thereby, the stent prevents collapse of the airway by mechanically splinting the throat.

The AlaxoStent has been multiply examined for its medical efficacy. The first clinical study in the sleep laboratoy of the ENT University Hospital of Erlangen, Germany (by Dr. Michael Hartl, MD) confirmed its therapeutic efficiency and acceptance by patients.

The AlaxoStent reduced the number of obstructive apneas as efficiently as CPAP therapy. Hypopneas were significantly or completely reduced, too.

 

without therapy

with
AlaxoStent

with
CPAP

AHI

31/h

19/h

8.2/h

obstructive apneas

43.0

2.2

2.5

minimal oxygen saturation

79%

84%

89%

Table 1: Results from the first clinical study (average values)

160+ propofol sleep video endoscopies (PSE) – which allow precise localization of the airway collapses in the throat in an artificial sleep – also have visualized the high effectivity of the AlaxoStent.

The published PSE study by Dr. János Juhász (Hospital Mainburg, Germany) demonstrates a very strong and elongated concentric collapse during sleep under propofol. The soft palate and the complete throat musculature fully collapse during sleep. The AlaxoStent effects a continuous air passage which enables unobstructed breathing and thereby abolishes the sleep apnea (see Fig. 2, poster by Dr. Juhász [Sleep Laboratory Hospital Mainburg, Germany] and propofol sleep endoscopy video at the bottom of this page).

AlaxoStent

Fig. 2: Splinting of the nasopharynx, soft palate and uvula by the AlaxoStent; view from the nasopharyngeal space down to the uvula and throat in propofol sleep video endoscopy (Dr. János Juhász, Mainburg, Germany)

The AHI of this patient was reduced from 74/h to 5/h


 

The product has been developed upon the initiative of a German OSA patient. Therefore, it notably complies with the needs and desires of the users.

The patient can move freely with the stent applied and it is visually inconspicuous. Further, the patient and his partner are not incommodated by the noise of the CPAP pump during the night.

Last but not least the patient maintains to breathe naturally and not artificially as with CPAP therapy which is a substantial advantage.

Snoring usually is completely abolished.

No pump and no electric current are required and the stent is quite small. Therefore, it offers particular advantages when travelling. According to experience there are no problems at airport security control.

The AlaxoStent must be prescribed by a physician with sufficient knowledge in treatment of OSA. The doctor instructs the patient in the correct use of the AlaxoStent and has to examine if the AlaxoStent is a suitable therapy for the patient. First self-application of the AlaxoStent by the patient shall be carried out in the presence of the physician.

The emotional hurdle of introducing the stent through a nasal passage into the throat is comparable with application of a contact lens to the eye. After education by the doctor and a short training period the patient according to experience can self-apply the stent safely and quickly.

In case of strong gag reflex sensitivity the AlaxoStent may not be the appropriate therapy.

The AlaxoStent is CE marked and approved for treatment of patients of age 18 and higher.


The AlaxoStent is positioned at the soft palate (see Fig. 3) and prevents collapse of the soft tissue in the velopharynx.

Grafik AlaxoStent

Fig. 3: Scheme for positioning of the AlaxoStent

In each case the attending physician has to examine (e.g. by polysomnography) which positioning is the right one for prevention of the patient-specific airway obstructions.

For controlling the therapeutic efficacy also propofol sleep video-endoscopy or digital volume tomography (DVT) may contribute highly valuable diagnostic and therapeutic information.


AlaxoStent

Abb. 4: Visualization of the AlaxoStent by DVT (Prof. Dr. Hans-Jürgen Wilhelm, ENT Center, Frankfurt, Germany)





The AlaxoStent information flyer can be downloaded here.

The AlaxoStent Instructions for Use can be downloaded here.


 


Information video for the AlaxoStent:

Download Video