Caparelli C, Carpino G, Brunetti G, Larizza P, Guglielmelli E
Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:450-3. doi: 10.1109/EMBC.2015.7318396.
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.
生物医学设备中的颠覆性创新在纳入临床实践前必须经过仔细评估，尤其是当这些新系统与人体相互作用时。在这种情况下，介入放射学的引导设备是一个备受关注的领域。本文对一种用于活检、热消融、经皮介入等经皮干预的CT导航系统SIRIO进行了测试和评估。分析了该系统在有效性和安全性方面的技术特征，并与传统CT引导活检进行了比较。根据临床证据，使用SIRIO进行的活检显示CT扫描次数、手术时间和患者吸收的辐射剂量都有显著减少。还报告了技术成本分析以及与对临床医生和患者的益处相关的社会影响。尽管SIRIO没有适当的报销程序，但仍讨论了该设备带来的短期和长期益处。
