NewBreez® Prosthesis

Innovative solution to reduce disorders associated with laryngeal dysfunction

1_couverture

Dysphagia (impossibility or difficulty in swallowing) is a problem that is manifested in the older patients in the case of stroke, Alzheimer’s disease and Parkinson’s disease. Dysphagia is also affecting the younger with other neurological diseases, as multiple sclerosis. It is estimated that 7-10% of the population over fifty suffers from this disorder, this percentage increases to 15% over sixty years of age.

Swallowing is a complex process which in normal conditions is divided into four main phases:

• oral preparation; it is a phase that includes all the changes of consistency, viscosity, temperature and size of the food;

• oral stage; it begins when the tongue pushes the food (bolus) to the posterior side of the mouth (pharynx); it is voluntary movement;

• pharyngeal stage; during this phase the epiglottis is automatically closed to prevent food and liquid to penetrate into the upper airways and lungs; it is involuntary movement;

• oesophageal stage, due to which the coupling bolus is pushed from the oesophagus to the stomach; involuntary movement.

NewBreez® Intralaryngeal Prosthesis proves to be the optimal solution for all those patients who have dysphagia due to an impairment of the pharyngeal stage: due to a deficiency in the brain or nervous system the epiglottis is not able to prevent food and liquids from penetrating into the pulmonary tract; the accumulation of organic matter could lead to an inflammation of the lungs and airways.

NewBreez® is a disposable device, implantable at the cricoid level, which allows the passage of air but not of liquid or solid components: the patient with dysphagia will now be able to swallow and eat safety.

The prosthesis stud is made in silicon whereas the valve component is made of titanium, both of medical grades.

In order to better adapt to different anatomies of various patients the NewBreez® Intralaryngeal Prosthesis is available in three different diameters:

  • diameters at cricoid level = 12 mm
  • diameters at cricoid level = 14 mm
  • diameters at cricoid level = 16 mm

2_inspiration

NewBreez® introducer, designed exclusively for this type of procedure, is required for a correct positioning of the NewBreez® Intralaryngeal Prosthesis.

NewBreez® introducer is made of polyoxymethylene (POM) and polyethylene (PE), both suitable for medical use. It is available in one size that fits all sizes of installations.

Both NewBreez® Intralaryngeal Prosthesis and NewBreez® introducer are sterilized with ethylene oxide, in accordance with ISO 11135-1.

NewBreez® Intralaryngeal Prosthesis is produced by PROTiP Medical SAS. This device, distributed exclusively on national territory by MOSS S.p.A., has been introduced in our product portfolio from the beginning of 2014.


PROTiP Medical SAS
8, Place de l’Hôpital
67000 Strasbourg
France
www.protipmedical.com