Bielefeld Balloon Catheter

Product Description

Bielefeld Balloon Catheter

A new therapy concept for the treatment of chronic tube dysfunction.

Obstructive tube dysfunction often involves a chronic functional defect in which the regular aeration and ventilation as well as the self-cleaning capability of the middle ear are limited. The consequences of this malfunction include the development of chronic otitis media which, in the worst case, may lead to the destruction of the middle ear structures, resulting in subsequent hearing loss.

In a practical clinical study, Professor Holger Sudhoff has proved that the Eustachian tube can be treated by means of a modified PTA catheter which is introduced into the tube with the aid of a special microendoscope specifically developed for this purpose. The microendoscope is constructed in such a way that the catheter may be advanced into the tube in a carefully controlled manner without injuring any critical structures. This minimally invasive procedure is extremely gentle on the patient.

A preoperative tubomanometry (TMM) is performed on the patients for a detailed assessment of tube function and in order to decide whether dilatation should be performed.

The treatment principle is similar to that of balloon dilation in vascular stenosis and has recently also been established in the treatment of chronic obstructive sinusitis. Studies on balloon sinuplasty have shown it to be a safe and reliable treatment procedure.

This study had to be divided into an experimental and a subsequent clinical stage so that a precise assessment of the feasibility and effects of tube dilation could be assessed.

Please be aware that so far there has not been suffi cient experience in the treatment of patients under 20 years of age.