The approval now includes the treatment of painful diabetic peripheral neuropathy, a diabetes complication affecting the lower extremities.
Diabetic neuropathy, a form of nerve damage often found in the legs and feet, is caused by prolonged high blood sugar levels. This condition is prevalent, with nearly half of the 37.3 million Americans with diabetes potentially experiencing it in their lifetime, according to the American Diabetes Association. Current pain management solutions are limited, with most being pain-relieving medications.
The WaveWriter Alpha SCS systems provide a non-opioid alternative, targeting chronic intractable pain in the lower extremities resulting from DPN. By sending mild electric pulses to the spinal cord, the system acts to halt pain signals on their way to the brain.
Jim Cassidy, president of neuromodulation at Boston Scientific, said the expanded approval marks an important advancement in diabetes treatment.
“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,” Cassidy said in a news release.
The FDA had previously OK’d the WaveWriter Alpha SCS systems in December 2020. The systems launched in the U.S. in 2021. The original FDA approval catered to the management of chronic pain in the trunk and/or limbs, including pains resulting from failed back surgeries, complex regional pain syndromes, and intractable low back pain and leg pain. With the latest FDA nod, the system’s scope now includes DPN of the lower extremities for paresthesia-based stimulation.
Boston Scientific says it has focused on personalizing pain relief, in contrast to”one-size-fits-all” treatments. The WaveWriter Alpha SCS systems include a set of four MRI conditional implantable pulse generators. The systems are Bluetooth-enabled and either rechargeable or non-rechargeable. They offer Fast Acting Sub-perception Therapy (FAST) that provides paresthesia-free pain relief in minutes, according to the company.
The pain relief portfolio at Boston Scientific also includes the Cognita Solutions suite — digital tools tailored for both patients and physicians. The company’s roster also includes the Vertiflex procedure to provide long-term relief from pain associated with moderate lumbar spinal stenosis — and the radiofrequency ablation offerings to treat chronic pain.
