Devices or systems proposed have to be, as
far as possible, unique and exclusive with clear
characteristics of originality and specificity of application..
Furthermore they should also represent the “State of the Art”
and Technological Innovation within the Diagnostic and Therapeutic
field of Cardiovascular market.
Basic requirements must be indispensability in daily clinical practice in addition to a clear essentiality and fundamental necessity of the proposed treatment.
The use of devices should be simple and their understanding should be quick and immediate. It should not be necessary any interventions of specialized personnel during the different phases of use except from standard ones required by the initial basic training related to the working features of the device itself.
Scientific relevance in support of clinical benefits will have to be proved by evidence of publications, studies or appropriate documentation to validate the effectiveness, the indispensability and any exclusive use.
A positive and relevant impact of the treatment cost in reference to the expected clinical benefits will also be a key factor for the appropriate placement of devices on the Italian market.