Boston receives expanded US FDA approval of SCS therapy for painful diabetic peripheral neuropathy


Boston Scientific has announced that the US 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.

The WaveWriter Alpha SCS systems were previously approved by the US 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 new approval expands the indications to include DPN of the lower extremities for paraesthesia-based stimulation, as per a Boston press release.

As a non-opioid treatment option, the WaveWriter Alpha SCS systems are intended 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 travelling to the brain.

″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,″ said Jim Cassidy, president of Neuromodulation at Boston. ″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.”


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