Sam Brusco, Associate Editor09.12.23
Medical technologies are integral tools for an effective pain management regimen that aims to reduce or remove the number of opioids used in treatment. These technologies range from a heating pad to alleviate muscle pain, to targeted drug delivery devices, to surgical or implantable neurostimulation that restricts pain signals.
Toward the end of August, Medtronic gained CE mark approval for Inceptiv, the company’s closed-loop, rechargeable spinal cord stimulator (SCS). The company said Inceptiv is the first of its SCS devices with a feature that senses biological signals and adjusts stimulation from moment to moment as needed.
Inceptiv can sense response to neural stimulation at 50 times per second. As response increases—for example, if the patient coughs, sneezes, or bends—the SCS automatically decreases stimulation. Should neural response decrease, stimulation returns to the device’s pre-set, optimal level to offer consistent therapy.
It uses closed-loop capability with evoked compound action potentials (ECAPS), which measure how much spinal cord neural tissue activates in response to electrical stimuli. This provides real-time info to let Inceptiv respond to patient movements.
“Today, fixed-output spinal cord stimulation does not account for patient movements, which can alter the distance between the spinal cord and implanted epidural leads,” Dirk Rasche, M.D., from the Department of Neurosurgery, University Hospital of Schleswig-Holstein in Lübeck, Germany, told the press. “This can compromise the patient´s experience and therapeutic effectiveness.”
In a clinical study, nine of 10 patients preferred the optional closed-loop setting compared to fixed-output stimulation. Medtronic said Inceptiv is the only SCS system in Europe that offers both 1.5T and 3T MRI access. It’s also the thinnest SCS device in the world at 6 mm (according to the company), and uses the company’s proprietary DTM spinal cord stimulation.
A few days later, Nalu Medical finished enrolling patients in its COMFORT-2 Clinical Study Of A Micro-Implantable Pulse Generator For the Treatment of Peripheral Neuropathic Pain peripheral nerve stimulation study. The study will compare responder rate of peripheral nerve stimulation (PNS) combined with medical management to the responder rate of conventional medical management alone.
Nalu PNS uses a battery-free, micro implantable pulse generator (micro-IPG) powered by an external device. It uses mild electrical pulses to make an energy field that modulates transmission of pain signals to the brain. The company claims that despite its small size, the Nalu micro-IPG delivers treatment capabilities on par with larger IPGs, in addition to advantages with advanced waveforms, extensive programming options, upgradability, and an expected service life of 18 years.
The COMFORT-2 trial will enroll up to 200 patients in up to 20 U.S. study centers. Subjects diagnosed with peripheral neuralgia, mononeuropathy, neuropathic pain, or osteoarthritis pain in the lower back, shoulder, knee, or foot will be randomized to PNS combined with conventional treatments or conventional treatments alone. The primary endpoints are responder rate at three months and rate of serious and non-serious adverse events. Secondary endpoints include responder rates and the rate of serious and non-serious adverse events at six and 12 months, as well as patient-reported functional outcomes.
At the start of September, Relievant Medsystems touted three-year, pooled results from two prospective clinical trials validating its Intracept Procedure for patients with vertebrogenic pain. Ninety-five patients were treated with the procedure and completed three-year study visits. The study showed statistically significant, clinically meaningful, and durable improvements in both pain and function, Relievant said.
At three years post-Intracept, statistically significant improvements of 31.2 points and 4.3 points were observed compared to baseline, for mean Oswestry Disability Index (ODI) and mean numeric pain score (NPS), respectively. The study also found 74% fewer patients were using opioid medications for low back pain and 84% fewer patients required spinal injections for the same pain source and treatment at three years after treatment.
“These aggregated three-year results demonstrate the sustained effectiveness of basivertebral nerve ablation in improving patients’ pain, productivity, and quality of life while decreasing their healthcare utilization,” said Matthew Smuck, M.D., chief of Physical Medicine & Rehabilitation and professor of Orthopaedic Surgery at Stanford University and lead study author. “The data also demonstrate that vertebrogenic pain is a distinct source of anterior column low back pain that is identified using an objective imaging biomarker.”
According to Relievant, its minimally invasive Intracept Procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain. The same-day, outpatient procedure uses targeted radiofrequency energy to stop the basivertebral nerve from transmitting pain signals to the brain and takes approximately one hour to perform.
Toward the end of August, Medtronic gained CE mark approval for Inceptiv, the company’s closed-loop, rechargeable spinal cord stimulator (SCS). The company said Inceptiv is the first of its SCS devices with a feature that senses biological signals and adjusts stimulation from moment to moment as needed.
Inceptiv can sense response to neural stimulation at 50 times per second. As response increases—for example, if the patient coughs, sneezes, or bends—the SCS automatically decreases stimulation. Should neural response decrease, stimulation returns to the device’s pre-set, optimal level to offer consistent therapy.
It uses closed-loop capability with evoked compound action potentials (ECAPS), which measure how much spinal cord neural tissue activates in response to electrical stimuli. This provides real-time info to let Inceptiv respond to patient movements.
“Today, fixed-output spinal cord stimulation does not account for patient movements, which can alter the distance between the spinal cord and implanted epidural leads,” Dirk Rasche, M.D., from the Department of Neurosurgery, University Hospital of Schleswig-Holstein in Lübeck, Germany, told the press. “This can compromise the patient´s experience and therapeutic effectiveness.”
In a clinical study, nine of 10 patients preferred the optional closed-loop setting compared to fixed-output stimulation. Medtronic said Inceptiv is the only SCS system in Europe that offers both 1.5T and 3T MRI access. It’s also the thinnest SCS device in the world at 6 mm (according to the company), and uses the company’s proprietary DTM spinal cord stimulation.
A few days later, Nalu Medical finished enrolling patients in its COMFORT-2 Clinical Study Of A Micro-Implantable Pulse Generator For the Treatment of Peripheral Neuropathic Pain peripheral nerve stimulation study. The study will compare responder rate of peripheral nerve stimulation (PNS) combined with medical management to the responder rate of conventional medical management alone.
Nalu PNS uses a battery-free, micro implantable pulse generator (micro-IPG) powered by an external device. It uses mild electrical pulses to make an energy field that modulates transmission of pain signals to the brain. The company claims that despite its small size, the Nalu micro-IPG delivers treatment capabilities on par with larger IPGs, in addition to advantages with advanced waveforms, extensive programming options, upgradability, and an expected service life of 18 years.
The COMFORT-2 trial will enroll up to 200 patients in up to 20 U.S. study centers. Subjects diagnosed with peripheral neuralgia, mononeuropathy, neuropathic pain, or osteoarthritis pain in the lower back, shoulder, knee, or foot will be randomized to PNS combined with conventional treatments or conventional treatments alone. The primary endpoints are responder rate at three months and rate of serious and non-serious adverse events. Secondary endpoints include responder rates and the rate of serious and non-serious adverse events at six and 12 months, as well as patient-reported functional outcomes.
At the start of September, Relievant Medsystems touted three-year, pooled results from two prospective clinical trials validating its Intracept Procedure for patients with vertebrogenic pain. Ninety-five patients were treated with the procedure and completed three-year study visits. The study showed statistically significant, clinically meaningful, and durable improvements in both pain and function, Relievant said.
At three years post-Intracept, statistically significant improvements of 31.2 points and 4.3 points were observed compared to baseline, for mean Oswestry Disability Index (ODI) and mean numeric pain score (NPS), respectively. The study also found 74% fewer patients were using opioid medications for low back pain and 84% fewer patients required spinal injections for the same pain source and treatment at three years after treatment.
“These aggregated three-year results demonstrate the sustained effectiveness of basivertebral nerve ablation in improving patients’ pain, productivity, and quality of life while decreasing their healthcare utilization,” said Matthew Smuck, M.D., chief of Physical Medicine & Rehabilitation and professor of Orthopaedic Surgery at Stanford University and lead study author. “The data also demonstrate that vertebrogenic pain is a distinct source of anterior column low back pain that is identified using an objective imaging biomarker.”
According to Relievant, its minimally invasive Intracept Procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain. The same-day, outpatient procedure uses targeted radiofrequency energy to stop the basivertebral nerve from transmitting pain signals to the brain and takes approximately one hour to perform.
