Sam Brusco, Associate Editor10.11.23
Boston Scientific has gained U.S. Food and Drug Administration (FDA) approval to expand the indication of its WaveWriter Alpha spinal cord stimulators (SCS) to treat painful diabetic neuropathy (PDN).
WaveWriter Alpha SCS systems offer a non-opioid treatment option for chronic, intractable lower extremity pain associated with DPN. The systems provide pain relief therapy by sending mild electrical pulses to the spinal cord to interrupt pain signals headed to the brain.
WaveWriter Alpha was initially FDA approved in December 2020 (and released a month later) to manage chronic, intractable pain of the trunk and/or limbs due to unilateral or bilateral pain due to failed back surgery syndrome, complex regional pain syndrome types I and II, and intractable low back and leg pain. The approval moves the SCS’ paresthesia-based stimulation therapy indications to lower extremity DPN as well.
"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,″ Boston Scientific’s president of Neuromodulation Jim Cassidy told the press. ″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."
Earlier this month, the company rolled out its LUX-Dx II insertable cardiac monitor.
WaveWriter Alpha SCS systems offer a non-opioid treatment option for chronic, intractable lower extremity pain associated with DPN. The systems provide pain relief therapy by sending mild electrical pulses to the spinal cord to interrupt pain signals headed to the brain.
WaveWriter Alpha was initially FDA approved in December 2020 (and released a month later) to manage chronic, intractable pain of the trunk and/or limbs due to unilateral or bilateral pain due to failed back surgery syndrome, complex regional pain syndrome types I and II, and intractable low back and leg pain. The approval moves the SCS’ paresthesia-based stimulation therapy indications to lower extremity DPN as well.
"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,″ Boston Scientific’s president of Neuromodulation Jim Cassidy told the press. ″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."
Earlier this month, the company rolled out its LUX-Dx II insertable cardiac monitor.