Spinal cord stimulation (also called SCS) uses
electrical impulses to relieve chronic pain of the
back, arms and legs. It is believed that electrical
pulses prevent pain signals from being received by
the brain. SCS candidates include people who
suffer from neuropathic pain and for whom
conservative treatments have failed.
· 34 million people have diabetes in the U.S.1 and roughly half of all adults with diabetes will suffer from diabetic neuropathy in their lifetime2
· ~2.3MM patients suffer from PDN with no relief from current treatments3
· Diabetic neuropathy is caused by chronically high blood sugars
· Nerve damage can cause pain and numbness that can make you more vulnerable to falls, burns, infections, ulcers and longer-term complications.
· Painful diabetic neuropathy can significantly interfere with a person’s quality of life, sleep and functionality.
· Treatment options include over-the-counter medications, prescription prednisone, physical therapy or injections, however for many patients these options are inadequate for long-term relief.
· Opioids, a commonly used tool in the management of diabetes related neuropathy, also present addiction potential, long-term dependence and show little evidence of improved function.
· New federal guidelines aimed at reducing opioid misuse and abuse has resulted in some physicians denying or limiting opioid therapy for some chronic pain sufferers. Physicians need better clinical and interventional tools to treat complex chronic pain.
· Roughly 45% of PDN patients are refractory to the traditional treatment options
· Finally, HFX provides a non-drug treatment for diabetes related neuropathy pain.
· A new treatment is available to help you manage shooting, burning, pins and needles pain associated with diabetic neuropathy
· Introducing HFX™ for PDN, a Senza spinal cord stimulation system that uses 10 kHz Therapy to treat pain from diabetic neuropathy.
· The HFX™ Solution for Painful Diabetic Neuropathy (PDN) provides significant pain relief without the side effects of conventional medical management
· HFX for PDN is the only spinal cord stimulator (SCS) system FDA approved with a specific indication for painful diabetic neuropathy.
· HFX 10 kHz Therapy calms the nerves and interrupts the transmission of pain signals to the brain, alleviating pain and improving quality of life.
· HFX 10 kHz Therapy is the most studied SCS therapy available and has been used to treat more than 70,000 patients with chronic pain.
· The effectiveness of HFX 10 kHz Therapy in controlling pain associated with diabetes related neuropathy compared to conventional treatments was tested in a large clinical study.4
· 85% of patients achieved at least 50% pain relief4
· An average 76% decrease in lower limb pain4
· 92% of patients were satisfied with their treatment4
· Significantly reduces pain and improves sleep4
· Reduces painful sensations like burning, tingling, and numbness4
· Patients can evaluate HFX for PDN in a temporary trial before having the device implanted. The implant procedure requires a minimally invasive outpatient procedure.
· HFX provides physicians and patients with a comprehensive solution to treat the complex and dynamic nature of chronic pain. As the nature of pain can change over time, vary in intensity or occur in different parts of the body, HFX provides the most flexible platform that allows patients to have access to all SCS frequencies and the most waveforms over the long term. Physicians no longer have to choose between traditional SCS therapy or 10 kHz Therapy. With HFX, they get both.
1. CDC 2020 National Diabetes Statistics Report.
2. Hicks CW, Selvin E. Curr Diab Rep. 2019;19(10):86
3. CDC National Diabetes Statistics Report 2020; Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354; Trinity Partners Market Research 2017
4. Petersen, E, et. al. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy A Randomized Clinical Trial. JAMA Neurology, April 2021.
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