The IONM is the use of electrophysiological methods to identify important neural structures
in the operative field, including eloquent areas (i.e. areas that if removed or damaged would
imply a loss of motor or language or sensory or vision abilities), in order to monitor their
functional integrity during the neurosurgical lesion resection. The benefit of performing
functional monitoring of the areas surrounding the lesion is to minimize neurological damages
during surgical lesions resection and thus to avoid and/or limit significant post-operative
impairments. During the therapeutic resection of brain tumors or epileptogenic lesions, the
use of the IONM is associated to other intraoperative techniques (e.g. brain mapping
techniques) that, together to combined efforts of a multidisciplinary team of neurosurgeons,
neuroradiologists, neuropsychologists, and neurophysiologists, contribute to the definition
of location, extension, and extent of functional involvement that a lesion causes in an
The principal electrophysiological methods to perform the IONM are the recording of brain's
electrical activities (Somatosensory Evoked Potentials, SEPs and ElectroCorticoGraphy, ECoG)
and electrical stimulation of motor regions (to elicit Motor Evoked Potentials, MEPs) using
cortical strips placed on surface of the brain.
Thus, the WCS is intended to be used intraoperatively on the brain surface, to perform SEPs
and ECoG recording and brain stimulation, aimed to elicit MEPs.
A clinical evaluation has been performed during the development phase of the WCS, to
investigate whether there is sufficient clinical evidence to demonstrate conformity of the
WCS to the MDD Essential Requirements covering safety, clinical performance and intended use
and to identify data that need to be generated for first market access. The relevant clinical
data collected on devices similar to the WCS are consistent with the current state of the
art, and demonstrate the safety, clinical performance and an overall acceptable risk/benefit
ratio of devices similar to the WCS when used according to the intended purpose in the target
treated population. However, since no devices currently on the market have been identified as
strictly equivalent to the WCS, these data cannot be used to support the safety, clinical
performance and intended use of the WCS. However, the results of the preclinical tests on
WCS, including a comprehensive study on sheep model, showed that the WCS is safe to use
as-is, and that its performances make the device suitable to be used in a clinical context
for the IONM.
Based on the results of the clinical evaluation and of the conducted pre-clinical tests, some
open points remain to be addressed at a clinical stage to confirm compliance of the WCS to
the MDD Essential Requirements and thus to undergo conformity assessment for WCS CE
certification. These open points are:
- - the safety of the WCS during a neurosurgical intervention conducted on humans, since
during the pre-clinical in vivo study on sheep model the intraoperative
neurophysiological monitoring was performed on the intact surface of the brain, exactly
as on humans, but without any ongoing neurosurgical intervention comparable to those
procedures conducted in participants with brain tumors or epilepsies.
- - the clinical performance of the WCS during a neurosurgical intervention conducted on
humans, to prove the clinical relevance of recordings and stimulations performed through
the WCS during an IONM procedure performed in a real clinical setting, where sources of
interference, not evaluated during pre-clinical testing, can be present.
- - the usability of the WCS during a neurosurgical intervention conducted on human, to
ensure the adequacy of the WCS to its intended use from users' perspective.
since only one neurosurgeon was involved in the usability evaluation during the
preclinical study in-vivo, further usability data need to be acquired on a more
representative sample of users, including also neurophysiologists.
These open points will be verified during the WIN Study. The "baseline phase" will be
conducted with the participant asleep under a constant anesthesiologic level and the duration
of the "baseline phase" will be dependent on data collection and is estimated to be within 10
minutes, considering simultaneous recordings from the WCS and the comparator device. During
"IONM phase", instead, the WCS is intended to remain on the brain surface for intraoperative
neurophysiological monitoring during the intervention. The duration of the "IONM phase"
depends on patient's brain lesion type and localization and will not be affected by the WIN
Study. In this phase, the WCS and (if applicable) the comparator device will be used for
performing intraoperative neurophysiological monitoring by means of electrophysiological
parameters such as MEPs, SEPs, ECoG, according to the site clinical practice.