Boston Scientific Receives FDA Approval of Spinal Cord Stimulation Therapy for People Living with Diabetic Peripheral Neuropathy

Nearly 50% of American adults living with diabetes will be affected by diabetic neuropathy complications in their lifetime

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Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication of the WaveWriter Alpha™ Spinal Cord Stimulator (SCS) Systems for the treatment of painful diabetic peripheral neuropathy (DPN), a complication of diabetes that can affect the lower extremities of the body.

Diabetic neuropathy is a type of nerve damage throughout the body, often impacting the nerves in the legs and feet. Over time, high blood sugar (glucose) can injure those nerves and it can lead to symptoms of pain and numbness in the legs, feet and hands. [i] Of the 37.3 million Americans that live with diabetes, or 11.3% of the U.S. population, diabetic neuropathy will affect approximately 50% of adults living with diabetes during their lifetime.[ii] For pain management, there are only a few alternatives, which include pain-relieving medications.

As a non-opioid treatment option, the WaveWriter Alpha Spinal Cord Simulation Systems are for chronic intractable pain of the lower extremities associated with DPN. The system provides therapy for pain relief by sending mild electric pulses to the spinal cord to interrupt pain signals traveling to the brain.

″The use of spinal cord stimulation to support a subset of the diabetes population is an important advancement for one of the fastest growing chronic conditions in the world,″ said Jim Cassidy, president of Neuromodulation, Boston Scientific. ″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 previously approved by the U.S. FDA in December 2020, for the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with failed back surgery syndrome, complex regional pain syndrome types I and II, intractable low back pain and leg pain. This approval expands the indications to include DPN of the lower extremities for paresthesia-based stimulation. More information on PAIN.