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2009-10-12  
Provox XtraFlange is launched

New professional accessory in the Provox System

Atos Medical expands the Provox System and introduces Provox XtraFlange.
Provox XtraFlange is a silicone washer, intended to reduce periprosthetic leakage in patients using indwelling Provox voice prostheses.
Periprosthetic leakage (leakage around) is a known problem for users of any type of voice prosthesis. This type of leakage is detected in 11-13% of voice prosthesis replacements.

Provox XtraFlange might for example be indicated for periprosthetic leakage caused by:

  • downsizing prosthesis diameter,
  • gastroesophageal reflux,
  • fistula created by scalpel,
  • other tissue related conditions.

How it works
The thin (0.4 mm) silicone washer is mounted while the prosthesis is in situ. It stays in place until the voice prosthesis needs to be changed. After the prosthesis is replaced, a new washer can be mounted if neccessary.
The thin material of the washer adheres to the tracheal mucosa and prevents leakage by means of surface tension. The washer is not glued to the prosthesis, which allows the prosthesis and the washer to move independently.
Always confirm that the voice prosthesis, in combination with the XtraFlange, is adequately retained in the puncture.

Benefits

  • Reduces the need to remove the voice prosthesis to treat periprosthetic leakage
  • Simple application
  • Quick
  • Atraumatic
  • Allows the prosthesis and washer to move independently
  • Instant confirmation of proper placement

Features

  • 3 different sizes (17Fr, 20Fr and 22.5Fr)
  • Sterile
  • Safety medallion (removed after application)

Note: Provox XtraFlange is not available in USA, pending 510(k) clearance.