Boston Scientific’s Neuromodulation System Receive FDA Approval for Treating Diabetic Peripheral Neuropathy; Joins Nevro, Medtronic, and Abbott in Increasingly Crowded Market

Boston Scientific Corporation announced that the U.S. Food and Drug Administration (FDA) has granted expanded approval for its WaveWriter Alpha™ Spinal Cord Stimulator (SCS) Systems. This approval extends the device’s application to the treatment of painful diabetic peripheral neuropathy (DPN), a common complication of diabetes that predominantly affects the lower extremities.

Diabetic neuropathy, a form of nerve damage typically seen in individuals with diabetes, primarily impacts the nerves in the legs and feet. High blood sugar levels can lead to nerve damage, resulting in symptoms like pain, numbness, and discomfort in the extremities. Approximately 30% to 50% of the 29.1 million individuals in the U.S. with diabetes will experience diabetic neuropathy during their lifetime. A competitor Nevro sizes the U.S. market for diabetic neuropathy at 2.6 million patients who are refractory to conventional medical management and the current total addressable market at $3.5 to $5.0 billion.

While pain-relieving medications are commonly used to manage the symptoms of diabetic neuropathy, the expanded indication for the WaveWriter Alpha SCS Systems offers a non-opioid alternative. These systems are designed to address chronic intractable pain associated with DPN by delivering mild electric pulses to the spinal cord, thereby interrupting the pain signals traveling to the brain.

Jim Cassidy, President of Neuromodulation at Boston Scientific, emphasized the significance of utilizing SCS as a treatment option for diabetes-related pain. “The use of SCS to support a subset of the diabetes population is an important advancement for one of the fastest-growing chronic conditions in the world,” he stated. Cassidy added, “This expanded indication is another testament to our commitment to delivering a robust portfolio of interventional pain solutions that provides physicians with more treatment choices to help their patients find relief.”

The WaveWriter Alpha SCS Systems were initially approved by the U.S. FDA in December 2020 for managing chronic intractable pain in various conditions, including failed back surgery syndrome, complex regional pain syndromes, intractable low back pain, and leg pain. This recent approval extends its application to include paresthesia-based stimulation for DPN of the lower extremities.

Nevro was the first company to receive FDA approval for a neuromodulation device for diabetic neuropathy with its HFX iQ device in 2023 followed by Medtronic’s Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulators in 2022. Earlier this year the FDA approved Abbott’s Proclaim XR spinal cord stimulation system for diabetic neuropathy as well.