The US Food and Drug Administration (FDA) has cleared Curonix’s application for expansion of labelled indications of its Freedom Peripheral Nerve Stimulator (PNS) System to include the craniofacial region.
Freedom PNS System is a non-integrated, minimally invasive implant designed to help relieve chronic pain. It does not incorporate an implanted battery.
Curonix is a Delaware-based medical technology company focused on developing and commercialising therapies that alleviate chronic pain without opioids.
The latest approval makes Freedom PNS the first and only system approved for full-body permanent PNS to manage chronic, intractable pain originating from peripheral nerves.
The system utilises high frequency electromagnetic coupling (HF-EMC) for power and consists of a two-component implantable neurostimulator.
It also includes an externally worn transmitter and software to set patient-specific stimulation programmes.
The neurostimulator includes an electrode array and a separate receiver surgically connected in separate incisions, including a subcutaneous pocket.
According to Curonix, the stimulation programmes are customised to deliver pain relief for the patient.
The medical technology company used an investigational device exemption (IDE) to conduct a multi-centre randomised controlled trial of patients receiving the Freedom PNS implant.
The results from this 60 patients study supported FDA’s 510(k) clearance.
In the trial, the patients were randomly assigned to activated or deactivated groups and were monitored at three, six-, and 12-months post-implantation.
The study was focused on showing significant long-term pain reduction with the implant. Curonix said that the study concluded that the Freedom PNS System is a safe and effective therapy for treating craniofacial pain originating from peripheral nerves.
Curonix CEO Aure Bruneau said: “At Curonix, we are committed to collaborating with leading physicians and their teams to redefine the boundaries of chronic pain management by addressing underserved areas like craniofacial pain.
“With this new full-body PNS indication and long-term clinical evidence, we’re expanding access for more patients who previously had limited treatment options, providing them potential relief from chronic pain through our innovative, long-term Freedom PNS System.”
