FDA approves Proclaim XR spinal cord stimulation for painful diabetic peripheral neuropathy
Abbott has announced that the FDA has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes
The Proclaim XR SCS system can provide relief to DPN patients in need of alternatives to traditional treatment approaches, such as oral medication. People who receive therapy from the Proclaim XR SCS system will also be able to use Abbott's NeuroSphere Virtual Clinic, a connected care app that allows people to communicate with a physician and receive treatment adjustments remotely.
Roughly 34.2 million Americans, or 10.5% of the U.S. population, have diabetes. Diabetic neuropathy, one of the complications of diabetes, is a type of damage seen predominately in nerves running to the feet. During their lifetime, approximately 50% of adults with diabetes will develop peripheral neuropathy, which may include symptoms such as pain and numbness in the legs, feet and hands.
Currently, there are no disease modifying treatments for DPN, only symptom management and behavioral modifications to mitigate further nerve damage that can result from high blood sugar (glucose) levels. Spinal cord stimulation is a non-opioid approach that has been used for more than 50 years to help manage chronic pain and is proven to be more effective than conventional medical management in the treatment of this type of chronic pain. As a global leader in diabetes care, Abbott is committed to bringing life-changing solutions, including diagnostics, nutritionals, medicines and medical devices such as spinal cord stimulation to help better the lives of people living with diabetes.
Following a successful minimally invasive trial and undergoing an implant with the Proclaim XR SCS device, patients will have the ability to control their therapy through an Apple device. The device can also be programmed using the company's proprietary NeuroSphere Virtual Clinic technology, a first-of-its-kind remote patient care technology in U.S. that allows users to communicate with physicians, ensure proper settings and functionality, and receive new treatment settings/adjustments remotely, as needed.
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