Answer: Biofilm (Bacteris and candida) overgrowth will occur in almost all patients. This will eventually cause material degradation, leakage through the prosthesis, or other incompetence of the valve. Radiotherapy, salivary content gastroesophageal reflux and dietary habits may influence how rapidly biofilm forms. It is therefore not possible to predict device lifetime.Laboratory testing shows that in the absence of bacteria and yeasts the device will maintain its integrity for 12 months of simulated use. Usage beyond this limit is under the sole discretion of prescriber.
Indications for replacement includes leakage through or (partial) blockage of the valve, degradation of the material, or medical indications such as problems with the puncture tract.
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