Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has enrolled the first patient in its Painful Diabetic Neuropathy (PDN) Sensory Study, which is the first prospective randomized controlled trial (RCT) to assess restoration of neurological function as a primary objective in patients with intractable PDN. The study will enroll up to 236 patients at multiple sites across the U.S. Patients will be randomized to conventional medical management or 10 kHz Therapy™ plus conventional medical management, with optional crossover to the other treatment arm at 6 months if those criteria are met.
The FDA has granted Breakthrough Device Designation for the PDN Sensory Study and this potential device indication. This designation by the FDA provides for an expedited review for a marketing application to expand Nevro’s FDA labeling and provide patients and health care providers with timely access to critical medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
“This PDN Sensory Study affords a path forward to building clinical evidence for slowing the progression of or improving sensory loss of the lower limbs in patients with chronic intractable pain and builds on the significant outcomes seen in the landmark SENZA-PDN RCT,” said Mitchell Engle, MD, PhD, Institute of Precision Pain Medicine in Corpus Christi, Texas. “It also offers a unique opportunity for patients with refractory painful diabetic neuropathy to participate in a research study utilizing 10 kHz SCS, a proven minimally invasive, completely reversible technology, with powered study endpoints targeting the disease modifying benefits of improved neurological function and pain relief.”
“The observed neurological improvements we saw in the SENZA-PDN study are unique to 10 kHz Therapy and have not been reported for any other competitive SCS modality,” said Kevin Thornal, CEO and President of Nevro. “Not only do we anticipate that this study will provide additional confirmatory evidence of the benefits of Nevro’s proprietary 10 kHz Therapy in these PDN patients, but we also believe that the additional Level 1 data generated will be very helpful as we continue to work with payers to expand PDN coverage generally and professional societies to update PDN clinical treatment guidelines.”
Diabetes and peripheral neuropathy pose a staggering socioeconomic burden, and there is no available disease modifying treatment option available for patients with PDN. In fact, every 20 seconds in the US there is a diabetes-related amputation according to the American Limb Preservation Society, and many of these amputations are preventable. Insensate or numb feet contribute to unrecognized injuries and foot ulcers as patients lack protective sensation. Foot ulcer treatment and associated amputation surgeries are costly, both economically and psychosocially. By restoring sensation in the feet, 10 kHz Therapy may alleviate this tremendous disease burden, prevent amputations, and enable patients to be more active, all of which would improve overall health and quality of life and of course reduce healthcare costs.
For more information on Nevro’s PDN Sensory Study, please visit the ClinicalTrials.gov website.
