3. SCIENTIFIC AND TECHNICAL BACKGROUND (See detailed report by Dr Fabienne Nsanze “ICT implants in the human body – a review” of February 2005 – annexed to this Opinion) 3.1. Current Applications and Research 3.1.1. Applications: ICT implants on the market This section contains information about implants in the human body that are available in commercial form and have been researched, in some cases, for decades. Active medical devices The history of implantable devices in clinical practice started in the 1960s with the development of the first heart pacemakers to replace the autonomic rhythm of the heart. Systems for bladder stimulation that allow paraplegics (paralysis of the lower limbs often resulting from spinal cord injuries) to control voiding followed in the 1980s. The most recent examples of active implants for functional electrical stimulation are stimulators to treat pain in patients with tumours and trembling caused by Parkinson’s disease, and to restore the grasp function in quadriplegics (paralysis of the arms, legs and trunk below the level of an associated spinal cord injury). Typical devices include the following: • Cardiovascular pacers for patients with conduction disorders or heart failure • Cochlear implants: the cochlear implant differs from the hearing aid in that it does not amplify sound and bypasses the damaged part to send sound signals directly to the auditory nerve. • Auditory Brainstem implant (ABI) is an auditory prosthesis that bypasses the cochlea and auditory nerve to help individuals who cannot benefit from a cochlear implant because the auditory nerves are not working. The brainstem implant stimulates directly the cochlear nucleus situated in the brainstem. • Implantable programmable drug delivery pumps: Administration of Baclofen for patients with Multiple Sclerosis with severe spasticity (intrathecal administration i.e. within the spinal canal) Insulin pump for Diabetes 7 • Implantable Neurostimulation Devices: the term “neurostimulation” relates to technologies that do not directly stimulate a muscle as a functional electrical stimulation device (i.e., cardiac pacemakers). Rather, neurostimulation technologies modify electrical nerve activity. Spinal cord stimulation for chronic pain management Sacral nerve stimulation for treatment of refractory urinary urge incontinence Vagus nerve stimulation (VNS) for seizure control in epilepsy or for mood control in severe depression cases • Deep brain stimulation (DBS): for tremor control in patients with Parkinson’s disease for essential tremor: Patients with essential tremor have no symptom other than tremor, which may occur in their hands, head, legs, trunk or voice. As for patients with Parkinson’s disease, they can be helped with deep brain stimulation therapy. • Artificial chip-controlled leg: the German company Otto Bock Healthcare GmbH has developed a prosthesis called “C-Leg®” which is a chip-controlled leg. Identification and location devices

www.icaact.org/files/european-groups-ethics-ict-implants-opinion-20.pdf

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