Painful Diabetic Neuropathy
Historical Management of PDN:
Historically, treatment approaches encompassed anti-seizure medications, antidepressants, opioids, and topical agents. However, many patients discontinued these therapies within six to twelve months due to ineffectiveness and adverse effects.
Understanding HFX for PDN:
Developed by Nevro, a California-based medical device company, HFX represents a Spinal Cord Stimulation (SCS) system.
Operational Mechanism:
A spinal cord stimulator, a technology employed for alleviating neuropathic back and leg pain over the years, is an implantable device delivering controlled low-level electricity directly to the spinal cord to mitigate pain. The application of mild electric pulses to the nerves interrupts pain signals en route to the brain, leading to pain relief and an enhanced quality of life. Nevro’s HFX for PDN administers 10 kHz Therapy to address this condition.
Assessing Appropriateness for HFX Treatment:
The initial step involves consulting a specialist who offers the HFX Solution and possesses extensive expertise with SCS. At Maxim Health, an initial consultation is conducted to evaluate the PDN condition, ascertain the viability of HFX treatment, and address any queries.
Trial Period and Implantation:
If deemed suitable, patients can undergo a temporary one-week trial of the HFX Solution. The trial system—administering the same therapy as the implanted device—entails a simple procedure within the clinic. Thin, flexible wires or leads are positioned under the patient’s skin, near the spine. A temporary device worn under clothing delivers stimulations to the leads, tailored to the patient’s pain experience. Following the trial, patients can evaluate pain relief and improvements in daily activities. Subsequent to a successful trial, the implantation involves a minimally invasive outpatient procedure. A small device is implanted under the skin, often above the beltline or in the buttocks region, and connected to thin, flexible wires akin to those used during the trial. Patients typically return home the same day. In select cases, a larger lead—known as a paddle lead—might require surgical implantation.
Effectiveness of HFX:
Remarkably, the majority of patients, around 85%, achieve sustained pain relief and improved sleep, devoid of the side effects associated with conventional treatments. HFX is non-addictive, doesn’t induce cognitive fog, drowsiness, or constipation like pain medications.
FDA Approval:
Among SCS systems for PDN, the HFX Solution stands unparalleled. It is the sole FDA-approved SCS system designed to address the shooting, burning, and pins-and-needles pain characteristic of diabetic neuropathy.
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