Wise first in Europe: brain electrode passes Mdr test

"We are told stories of patients who have been operated on a second time with our electrode, who have achieved a complete remission of their epilepsy thanks to its conformability. These are cases that repay us for all the effort we put in," says Ravagnan.

The clinical study, conducted on 32 patients in Europe, compared the Wise Cortical Strip with conventional electrodes during neurosurgical interventions.

'The clinical study was crucial in demonstrating the safety and efficacy of our electrode compared to traditional electrodes,' adds the CEO. 'It was completed in 2020, before the pandemic, and was crucial in obtaining the new certification.

The Wise Cortical Strip is the company's flagship product and demonstrates the potential of Supersonic technology, Wise's patented platform for advanced, flexible and minimally invasive neuro-electrodes. The same technology is also behind the Heron lead, the first unidirectional multi-column lead for spinal stimulation currently on the market.

Obtaining Mdr certification allows Wise not only to consolidate its presence in the European market, but also to continue the development of the Wiseneuro Monitoring line and to guarantee continuity in marketing beyond the expiry of the transitional period provided for by the previous regulations.

"The Mdr regulation has raised the bar a lot: nowadays, obtaining the CE marking is much more difficult and expensive, especially for invasive devices like ours," Ravagnan observes. "The risk is that not all manufacturers will be able or willing to recertify their devices, so there will be a selection: those who have 100 products will probably only keep the most profitable ones.

"Many players are leaving the European market or postponing recertification. In this context, arriving first is an important competitive advantage'.

Wise is already working on new product variants to expand the available range.

"We are expanding the catalogue: we will make a series of product variants both in size and in the number of electrodes or thicknesses," Ravagnan anticipates. "This will give rise to siblings and cousins of our current electrode, also in the neurosurgical field.

With this achievement, Wise confirms its leadership in the field of neurosurgical devices, pushing forward the boundaries of technology in the service of medicine.