The collaboration with Nevro. Corp. results in the only Spinal Cord Stimulation Therapy approved by FDA to treat painful diabetic neuropathy
BRADENTON, Fla. — Coastal Orthopedics, an orthopedic surgery practice whose physicians specialize in orthopedics and pain management, alongside surgical device vendor Nevro Corp., recently announced the receipt of FDA approval of a Spinal Cord Stimulation (SCS) treatment of Painful Diabetic Neuropathy (PDN). Specifically, the approval is for Nevro’s 10kHz stimulation and is now the only SCS system approved by the FDA with a specific indication to treat PDN for long-term relief.
More than 34 million people in the U.S. have diabetes, and it’s estimated that 20 to 25 percent of people with diabetes will develop PDN. The condition is associated with a wide range of symptoms, including pain in the limbs described as burning, freezing, stabbing, shooting, hypersensitivity or deep aching. Traditional treatment options for PDN include over the counter medications, prescription medications, physical therapy and injections. For most people, these options do not provide long-term relief.
Prior to receiving FDA approval for this new system, Coastal Orthopedics’ Dr. Richard H. Bundschu, and Dr. Gennady Gekht, pain management specialists, together with the research department at the practice took part in the largest study to date for SCS treatment of PDN. This study focused on alternate treatment options as Dr. Bundschu and Dr. Gekht recognized that there was a need to change the way patients were treated for this condition since neuropathic pain medications can lead to significant side effects.
“People with chronic PDN know it is a cruel addition to the chronic disease they have to fight daily,” said Dr. Bundschu. “This new treatment is a comprehensive solution that includes the insertion of the Senza spinal cord stimulation system into the patient in a minimally invasive procedure. It delivers mild pulses at a high frequency directly to the spinal cord to stop pain signals from reaching the brain. There is no other treatment or therapy like this, so having the ability to offer it to my Bradenton and Sarasota patients is an incredible opportunity.”
The research conducted for 10kHz SCS treatment consisted of participants who were enrolled at 18 research sites across the US, including academic centers and independent pain clinics. The dates ranged from August 2017 through August 2019, with 430 candidates screened resulting in 216 randomized patients with PDN. The participants clearly showed long term and continuous improved outcomes with this treatment and improved overall health-related quality of life. The results were published in JAMA Neurology in April 2021 and presented in the 2020 North American Neuromodulation Society Virtual Meeting (NANS). This new alternate treatment option gives patients pain relief through non-medication-based treatment and is the only SCS system with a specific indication to treat the condition. In a recent study, 92 percent of patients reported high satisfaction with the therapy.
“When we first partnered with Nevro on research for alternative treatments for PDN, we noticed that despite the best medical treatments available, many patients continued to experience chronic pain and inadequate relief,” said Dr. Gekht. “This FDA approval for alternate 10kHz stimulation is a monumental proof point that our research and data is beneficial in finding alternate SCS treatments to improve long term treatment of PDN.”
About Coastal Orthopedics
Founded in 1973 and based in Bradenton, Fla., Coastal Orthopedics is home to 20 orthopedic surgeons and pain management physicians who maintain hospital affiliations with Blake Medical Center, Doctors Hospital of Sarasota, Manatee Memorial Hospital and Lakewood Ranch Medical Center. In addition to three offices and two ambulatory surgery centers each servicing Florida’s West Coast, Coastal Orthopedics’ board-certified and fellowship-trained physicians and surgeons provide patients with the very latest in pain and orthopedic treatment technology. The company strives to repair and heal injuries relating to the entire musculoskeletal system.
For more than 45 years, its highly skilled staff of physicians and surgeons has treated patients in specialty care, including sports medicine, joint replacement, pain management and rehabilitation. Patients can experience restoration of function both surgically and non-surgically through the use of physician-guided strengthening, therapy, medications, injections and stretching. For more information, please visit CoastalOrthopedics.com or call 941-792-1404.
About Dr. Richard H. Bundschu
Dr. Richard H. Bundschu is an internationally recognized leader in pain management who is proficient with spinal injections, facet injections, radio-frequency vertebroplasty and kyphoplasty and implantable spinal cord stimulators. He received his doctor of medicine from the University of Miami, where he also completed a residency in anesthesia and a fellowship in pain management. As a recognized expert, he trains other pain management physicians for the International Spinal Interventional Society and maintains board certifications with the American Board of Anesthesiology, the American Board of Pain Medicine, the American Board of Pain Management and the American Board of Interventional Pain Physicians.
About Dr. Gennady Gekht
Dr. Gennady Gekht is a board-certified pain management physician who specializes in interventional treatments of the neck and spine. He is especially interested in neuromuscular disorders related to pain of the legs, hands, neck, and back. Dr. Gekht also specializes in Spinal Cord Stimulation, vertebral compression fractures, and pelvic fractures. He is trained in headache management receiving certification for headache medicine from United Council for Neurologic Subspecialties. Dr. Gekht is passionate about uncovering new advancements in interventional pain management treatments and works closely with the International Pain Institute teaching his peers the latest procedures in interventional care.
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