Sense of feeling restored for amputees – no more phantom limbs
There is an estimated 3.18 million people in the EU with lower limb amputations and about 295 000 amputations are performed annually. Currently used prostheses do not have sensory feedback resulting in amputees having lack of confidence in the prosthesis and reduced mobility. Patients may even abandon use of the prosthesis altogether, and at best, reduce their activity levels in everyday tasks dramatically. The EU-funded project SENSY has developed a solution, a complete sensory-motor link between the peripheral and central nervous system. As Dr Francesco Petrini, CEO of Sensars Neuroprosthetics, the coordinating company explains, “This enables the prosthesis user to feel it as part of their own body enabling natural movement and posture, reducing the risk of falls.” SENSY in action The neurostimulator is implanted in the limb and is wired to multi- and intra-fascicular intraneural electrodes that are inserted transversally into the peripheral nerves. Sensory nerve stimulation is driven wirelessly by an external controller that transduces the readout of the sensors embedded in the sole into stimulation parameters. The sensorised sole can be put into a shoe under any prosthesis available on the market. As an add-on, the ‘artificial skin’ is an accessory to the device and is compatible with prostheses currently on the market such as Rheo Knee and C-Leg. Feedback from trials incorporated into the product Preclinical trials on the first version of the neural electrode sized as big as a hair were performed on animals. Clinical trials were then run with seven patients in clinical centres in Rome and Belgrade, which proved the benefit of restoring sensory feedback to upper and lower limb amputees through their prosthesis. “Based on these results,” points out Dr Petrini, “the team have designed an upgraded version of the neural interface to enable the surgeon to execute its implantation using a much easier procedure.” A full feasibility study With the end of the project in December 2017, the researchers undertook a full feasibility study on their sensory restoration device, SENSY, defining the remaining technical activities to reach commercialisation and a detailed analysis of the go-to-market strategy. “Perhaps the most important of these was the final specifications for the minimum viable product to be commercialised, both hardware and software,” states Dr Petrini. For clinical trials, the future partners were identified and contacted to perform final clinical trials in two different sites. Also, planning in collaboration with other institutions Europe-wide is ongoing for other proof of concept clinical trials to assess the feasibility of using the SENSY product for different indications. Fully prepared for manufacture and marketing The researchers have identified and planned for the required manufacturing practice accreditations. Evaluations were scheduled to obtain the International Organization for Standardization (ISO) certification and the CE mark. A feasible preliminary industrialisation plan was established and business operations were elaborated. The team identified all the value chain actors and outlined the manufacturing and distribution infrastructure. Sixty patients will participate in clinical trials planned at the Policlinico Gemelli Hospital in Rome and the Charité Clinic in Berlin. “After this milestone, we will apply for the CE mark and start commercialisation of the SENSY in Italy and Germany, ready for expansion throughout the rest of Europe,” sums up Dr Petrini.
Keywords
SENSY, trials, prosthesis, amputee, sensory feedback, electrode, phantom
