MARLBOROUGH, Mass., Oct. 11, 2023 -- 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 SCS 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 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, 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.
For more information about chronic pain, visit Pain.com.
About the Boston Scientific Chronic Pain Portfolio
Where many “one-size fits all” treatments fail to provide long-term relief, Boston Scientific understands that it takes personalized pain relief solutions to improve patient outcomes. The WaveWriter Alpha™ Spinal Cord Stimulator (SCS) Systems include a unified portfolio of four MRI conditional[iii], Bluetooth-enabled rechargeable and non-rechargeable implantable pulse generators to provide uncompromised personalization, and for the first time in SCS, Fast Acting Sub-perception Therapy (FAST™), designed to deliver profound paresthesia-free pain relief in minutes. The systems are supported by the Cognita™ Solutions suite of digital tools for patients and physicians. Other solutions include the Vertiflex™ Procedure[iv], a unique treatment clinically proven to provide long-term relief from pain associated with moderate lumbar spinal stenosis, and the Radiofrequency Ablation (RFA) offerings for physicians to help treat chronic pain with a minimally invasive, non-surgical, outpatient procedure that uses thermal energy to interrupt pain signals at their source.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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[i] Mayo Clinic. Diabetic neuropathy symptoms. https://www.mayoclinic.org/diseases-conditions/diabetic-neuropathy/symptoms-causes/syc-20371580. Accessed October 5, 2023.
[ii] American Diabetes Association. Statistics about diabetes. https://diabetes.org/about-diabetes/statistics/about-diabetes Accessed October 8, 2023.
[iii] The WaveWriter Alpha™ SCS System provides safe access to full-body MRI scans when used with specific components and the patient is exposed to the MRI environment under the defined conditions in the ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator System.
[iv] Superion™ Indirect Decompression System