ARC-IM IPG is said to stimulate the spinal cord to restore movement and autonomic function for people with spinal cord injury and other mobility-related conditions
Switzerland’s Lausanne University Hospital Neurosurgeon Dr. Jocelyne Bloch holding ARC-IM IPG. (Credit: ONWARD Medical)
Dutch medical technology firm ONWARD Medical has recruited the first patient in the HemON Study and the first-in-human use of the company’s ARC-IM implantable pulse generator (IPG).
ARC-IM IPG is said to stimulate the spinal cord to restore movement and autonomic function for people with spinal cord injury and other mobility-related conditions.
The HemON Study aims to assess the safety and preliminary efficacy of ARC-IM Therapy in improving blood pressure management and trunk control in people with spinal cord injury who have orthostatic hypotension.
Orthostatic hypotension has been found in about 75% of persons who have had a spinal cord injury. HemON will enrol up to 16 participants at Lausanne University Hospital (CHUV) in Lausanne, Switzerland.
CHUV functional neurosurgery chief Dr Jocelyne Bloch said: “ONWARD’s ARCIM IPG offers surgeons precision and flexibility never before available in an implantable neurostimulator
“Clinicians will be able to leverage these advanced capabilities to refine and deliver epidural stimulation therapies for people with spinal cord injury.”
According to the company, the IPG aims to provide precise electrical stimulation to the spinal cord in the regions responsible for initiating or regulating movement and autonomic processes that may be compromised by a spinal cord injury or neurodegenerative illness.
It works in a closed-loop system, combining data from sensors and other devices placed within or outside the body.
IPG gives therapy with precision and flexibility using an ARCIM lead, allowing physicians to use biomimetic stimulation to mimic normal spinal cord activity patterns during movement or autonomic function.
ONWARD CEO Dave Marver said: “The first implant of our ARCIM IPG is a huge milestone for ONWARD and the SCI community.
“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.”
In June last year, the company secured breakthrough device designation from the US Food and Drug Administration for its ARC-IM platform.
ONWARD is engaged in creating new therapies to restore movement, independence, and health in people with spinal cord injury.