According to the 2020 Centers for Disease Control and Prevention report, roughly 34.2 million Americans have diabetes, and its prevalence continues to rise. 

Studies show that half of the people with diabetes will eventually develop peripheral neuropathy, a type of nerve damage that can eventually manifest as a burning, excruciating, shooting or stabbing pain known as painful diabetic neuropathy (PDN). 

Depending on the nerve damage, the pain can range from mild to severe. Some say it is like having pins and needles sticking to the limbs all the time, others describe it as shooting or freezing. PDN alters the quality of a patient’s life, causing interference in sleep and daily activities. Some patients experience depression and hopelessness. 

People with PDN manage the complication with medications, topical agents and opioids. While these painkillers can reduce the pain, they can only do so for a small period of time. Some people develop a tolerance to painkillers, continually needing to up their prescription to find relief. Others become physically dependent, showing withdrawal symptoms when the drug is stopped. 

Very strong painkillers, like opioids, are considered by some medical professionals to be a “last resort” due in part to their risk of addition. With few treatment long-term options, people living with PDN need more advancements for effective pain relief. 

Now they have one. 

The Only SCS to Treat Painful Diabetic Neuropathy

In 2021, Nevro introduced HFX for PDN, the only nondrug SCS option approved by the FDA to treat PDN. HFX for PDN is designed to disrupt pain signals before they reach the brain by delivering mild electrical pulses to the nerves.

Meredith Vornholt, Senior Director of PDN Marketing, explains more about HFX for PDN. 

“For patients who have been struggling for years to find relief from their painful diabetic neuropathy, who have been trying drug after drug to find relief, we now have a newly approved nondrug option for these patients, and they are finding significant relief versus the conventional treatment that they’ve tried in the past. For patients that haven’t been able to sleep through the night, not have their sheets touch them, not be able to feel their feet underneath them, they are now finding relief and sleeping through the night and feeling their feet and being able to participate in life with their family. So HFX for PDN is truly a new solution for patients.”

HFX for PDN is a comprehensive solution that includes a Spinal Cord Stimulation (SCS) System and support services such as a personal coach to create a holistic approach to pain management. It includes the only SCS system approved by the FDA with a specific indication to treat PDN. 

SCS is well-established as a non-pharmacological treatment for patients with intractable pain conditions. Studies show that through the implanted pulse generator, electrical signals can modulate neural signaling in the spinal column to reduce pain.

Most SCS technology does this by delivering a low-frequency waveform felt as a tingling sensation called paresthesia. However, unlike other SCS devices, HFX delivers proprietary high frequency signals called 10 kHz Therapy, which prevents the common side effect of paresthesia. 

Nevro is the only company with devices that operate at very high frequencies, yet that’s not all the HFX™ platform can do. 

HFX incorporates an advanced form of spinal cord stimulation that offers the widest range of frequencies and waveforms to provide individualized relief. In addition to treating PDN, it is also designed for individuals who suffer from leg pain, back pain and patients who have tried surgery or medication before but did not obtain effective results.

Leveraging Technology for Improved Patient Support

HFX™ combines innovative technology, advanced therapies, and end-to-end support. 

In the first half of 2021, Nevro introduced the HFX solutions platform, which included the full U.S. market launch of the company’s recent Omnia software upgrade, called HFX Connect™, and additional patient support resources (HFX Coach™). 

HFX Connect is an upgrade inspired by the pandemic that allows more patients to experience remote therapy optimizations without the need to undergo an in-person office visit. It includes more preloaded programs and optimization algorithms that can be administered remotely. This system greatly enhances the physician’s ability to support patients and helps in creating custom programs and therapies to give better relief to patients. 

With HFX Coach, patients, even those who are in the trial or testing period of the device, can  speak with a coach who can pull up their information, answer their questions, help with the therapy, and walk them through the program process. The coaches are real-world experts and part of the care team. 

Delivering Value to Both Patients and Providers

In healthcare, we like to think of long-term solutions.

Chronic pain is a lifetime burden for patients, not just physically but also financially. Having PDN often means ongoing doctor’s visits, taking multiple medications, having mobility restrictions, being unable to work, and enduring a poor quality of life. 

With HFX for PDN, many patients can say goodbye to pain medications and their side effects. They can get back to simple yet important tasks such as driving, walking and working.  Ultimately, they can get back to participating in the activities that bring them joy.

The HFX for PDN website has amazing stories of patients whose lives were changed by the treatment. 

Mindy suffered from painful diabetic neuropathy for 15 years, and when she received her implant, she said she felt immediate relief, and all the pain was gone. She said she no longer needs to depend on anybody else and can do things herself.

Neil started experiencing PDN six or seven years ago and shared that after his HFX treatment, he takes zero medication for his diabetic neuropathy. According to Neil, HFX changed his quality of life and his attitude. He said he feels he has a future.

For more patient stories, please visit https://www.hfxforpdn.com/patient-stories/.

It’s not just patients who benefit from this nondrug solution. Providers are happy to provide a long-term solution that does not require drug therapy and has no drug-related side effects. When conventional drugs and treatment fail to provide adequate relief,  providers can now offer an effective solution to help patients manage the pain. 

For more information on HFX for PDN, please visit the website at https://www.hfxforpdn.com/about/about-us/.

To listen to my full interview with Niamh Pellegrini and Meredith Vornholt, check out https://outcomesrocket.health/nevro-2/2021/08/.

*HFX is a comprehensive solution inclusive of a Senza™ Spinal Cord Stimulation system and support services for the treatment of chronic pain, including painful diabetic neuropathy when programmed with a frequency of 10 kHz