The first in-human use of an implantable pulse generator (IPG) has been made by ONWARD, stepping up its efforts to help change the futures for people with spinal cord injury (SCI).
The ARC IM IPG is designed to stimulate the spinal cord to restore movement and autonomic function for people with SCI and other conditions that impact mobility.
Its implantation into a human for the first time marks the start of patient enrolment in ONWARD’s HemON Study, which aims to enrol up to 16 participants at Switzerland’s Lausanne University Hospital (CHUV), to evaluate the safety and preliminary efficacy of ARC IM therapy to improve blood pressure management and trunk control in people with SCI.
Orthostatic hypotension affects around 75 per cent of people with SCI, and is characterised by debilitatingly low blood pressure that may occur when people sit upright, stand, or change body position.
“ONWARD’s ARC IM IPG offers surgeons precision and flexibility never before available in an implantable neurostimulator,” said Dr Jocelyne Bloch, chief of functional neurosurgery at CHUV.
“Clinicians will be able to leverage these advanced capabilities to refine and deliver epidural stimulation therapies for people with spinal cord injury.”
The IPG and HemON Study build further on the progress of ONWARD in giving hope to people with SCI, with its STIMO-BRIDGE study showing the potential of its ARC IM technology through enabling paralysed people to regain the ability to walk, stand, swim and cycle, supported by intense rehabilitation.
Its Up-LIFT study, involving 14 leading SCI sites across the UK, United States, Canada and the Netherlands, is gathering the data to prove the efficacy of its ARC EX technology.
The ONWARD ARC IM IPG was purpose-designed to deliver targeted electrical stimulation to the spinal cord in the precise areas responsible for triggering or controlling movement and autonomic functions that may be affected by a spinal cord injury or neurodegenerative disorder.
The IPG is designed to operate in closed-loop, incorporating data from sensors or other devices that may be deployed inside or outside the body.
It is also designed to deliver therapy through an associated ARC IM lead with precision and flexibility, allowing clinicians to apply biomimetic stimulation that can closely replicate normal spinal cord activity patterns during mobility or autonomic function.
“The first implant of our ARC IM IPG is a huge milestone for ONWARD and the SCI community,” said Dave Marver, CEO of ONWARD.
“This important achievement validates our vision for a future in which clinicians will no longer need to struggle with modified pain stimulators to explore new treatments and instead will be able to use devices and therapies designed specifically to treat people with spinal cord injury and their unique needs.”
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