The label expansion for Intellis Platform is based on the clinical trial of DTM spinal cord stimulation (SCS) in treating chronic intractable back pain
US FDA revises labelling of the Intellis Platform. (Credit: kalhh from Pixabay.)
Medical technology firm Medtronic has received the US Food and Drug Administration (FDA) approval to expand the commercial labelling for its Intellis Platform.
The platform leverages differential target multiplexed (DTM) spinal cord stimulation (SCS) programming for the treatment of chronic, intractable back and leg pain.
Medtronic stated that its Intellis platform is the world’s smallest implantable neurostimulator, powered by its unique Overdrive battery technology.
Intellis is designed to address the limitations found in other SCS systems and is optimised for varied energy demands and offers effective long-term pain relief for patients.
It features SureScan MRI technology, and AdaptiveStim technology, which automatically controls the stimulation based on the patient’s requirement in different body positions.
Medtronic vice president and pain therapies general manager Charlie Covert said: “The body of clinical evidence proving the efficacy of DTM SCS in treating patients with chronic back pain continues to grow.
“The updated labelling further strengthens the credibility of the outcomes from this therapy, and parallels the profound benefits our clinician partners are seeing with their own patients.”
The updated labelling will include study outcomes from a multicentre randomised control trial that evaluated treatment for back pain using DTM SCS, compared to conventional SCS.
In the clinical trial, DTM SCS programming is clinically and statistically superior to conventional SCS programming, in treating intractable chronic back pain.
In patients treated with DTM SCS, 80% of them reported at least 50% relief of back pain, as measured by the Visual Analog Scale (VAS), a measure for pain intensity.
Also, the clinical trial showed statistically significant and superior back pain relief with DTM SCS compared to conventional SCS, at 12 months.
DTM therapy is available only on the Medtronic Intellis platform and is used for treating chronic pain based on years of preclinical research, said the medical technology company.