A preliminary health technology assessment of a guidance system for interventional radiology.

Disruptive innovation in biomedical devices have to be carefully assessed in order to be included in the clinical practice, especially when these new systems interact with the human body. In this scenario the guidance devices for interventional radiology represent an area of great interest. In this paper a CT-navigation system, SIRIO, used for percutaneous interventions such as biopsy, thermal ablation, percutaneous interventional, is tested and assessed. The technical features of the system in terms of efficacy and safety and the comparison with the traditional CT-guided biopsy are analyzed. According to the clinical evidences, biopsies carried out with SIRIO show an important reduction of number of CT scans, procedure's time and radiation dose absorbed by the patients. The analysis of the technology costs, the social impact related to the benefits to clinicians and patients are also reported. Although SIRIO does not have an appropriate reimbursement procedure, short- and long-term benefits introduced by this device are discussed.