N.I.C.E. is a Medical Device for medical professionals, specifically cardiologists and cardiac electrophysiologists.
N.I.C.E. is a medical software package used to collect, archive, and display clinical information and health documentation referring to electrophysiologists procedures destined patients.
N.I.C.E. is a class B medical device, a software package which processes medical images, cardiac electroanatomical information, and patient data.
N.I.C.E. has two possible configurations:
N.I.C.E. has no parts or materials that will be in contact with tissues or body fluids.
N.I.C.E. has no known contraindications.
N.I.C.E., given DICOM CT images of torso and heart, and given a digital standard 12-lead electrocardiogram, provides visual 3D information about the heart anatomy and the morphology of coronary veins through an automatic segmentation procedure of cardiac structures. Additionally, it generates an epi- and endocardial electrical activation map, which provides an opportunity to visualize the latest activation zone and reach the target zone for successful Cardiac Resynchronization Therapy (CRT) procedures.
N.I.C.E. approach is to provide all the relevant information about the patients’ heart and coronary sinus anatomy and the propagation of the electric stimulus, using routine and non-invasive clinical data (computer tomography and 12-channel ECG) as input. In this way, the electrophysiologist will be able to make informed decisions on the ideal LV lead placement for each patient ahead of any kind of conventional invasive intervention, or even plan alternative implantation beforehand.
N.I.C.E. gives the possibility to the physician to make a pre-procedural evaluation, with no interaction with the patient and is designed to be used by qualified medical professionals and the users are solely responsible for making all final patient management decisions.
