Enterprise Software for a Cyroablation Console

Based on joint research on cardiac arrhythmias by the University hospital Innsbruck and the UMIT in Hall/Tyrol the start-up enterprise Fischer & Hintringer GesbR - AFreeze was founded. Based on the patent US 6,979,331 B2 and the application EP 1356779 an ablation catheter for the treatment of the most frequent rhythm disorder atrial fibrillation (AF) is developed which should enable a more effective therapie at reduced costs. As a particular property of this catheter long linear lesions are created by freezing. The development of the catheter is funded by the AWS Gmbh and CAST GmbH. For the operation of the catheter a medical device - the cryoconsole - is needed. This console controlls freezing, stores data aquired during treatment and has to ensure that no harm is caused to the patient in the case of a fault condition. The development of an enterprise software which controls all functions of the console is the issue of this project. By the employment of Mr. Leonhard Wieser as a Doktor of Biomedical Informatics AFreeze wants to establish compentece for the development of medical software in the long run. In his Ph.D. thesis Mr. Wieser was working on the investigation of the maintaining mechanisms of AF by computer modeling. This qualification and experience is invaluable for the development starting from basic science and leading in three phases (in-vitro test, animal model and clinical study) to the market entry. In the project the opitmization of the cooling power (effective therapy) and functional safety of the medical devices are central issues. Thus, all functions within the first three months of the project all required functions of the console have to be listed in the specification. The implemented functions will be tested in the in-vitro test, the animal model and the clinical study. With respect to the certification of the catheter and the console the results will be collected according to the guidelines of technical documentation for medical devices. The scientific publication of the study results is planned.