FDA Approval of Proclaim XR Spinal Cord Stimulation System

The FDA has approved the Proclaim XR spinal cord stimulation system for the treatment of people living with painful diabetic peripheral neuropathy.

The Proclaim XR SCS system can provide relief to patients with diabetic peripheral neuropathy 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.

Diabetes and Diabetic Neuropathy

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.

Proclaim XR SCS System

Approved for the treatment of chronic pain in 2019, the Proclaim XR SCS system now offers DPN patients relief from chronic pain by delivering low amounts, or doses, of stimulation. Unlike other SCS systems that require frequent charging sessions to maintain therapy, the Proclaim XR SCS system provides hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings. People experiencing DPN can engage with their healthcare provider to be referred to a pain management specialist or spine surgeon to discuss the details of this treatment to determine the best course of care.

"Diabetic peripheral neuropathy has long plagued people affected by type 1 and type 2 diabetes, often adding another area of disease management on top of their ongoing monitoring of their glucose levels to manage this challenging disease," said Jason E. Pope, MD, DABPM, FIPP, president of Evolve Restorative Center in Santa Rosa, Calif. "Abbott's Proclaim XR spinal cord stimulation system provides patients with painful diabetic peripheral neuropathy the opportunity to obtain a better quality of life while more seamlessly fitting into their current lifestyles."

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 the U.S. that allows users to communicate with physicians, ensure proper settings and functionality, and receive new treatment settings/adjustments remotely, as needed.

"As a leader in diabetes care, Abbott is intimately familiar with the challenges people with diabetes encounter daily. This new indication for Proclaim XR will drive meaningful change in the treatment of pain associated with diabetic peripheral neuropathy and will be an important tool for physicians and patients in managing this debilitating condition," said Pedro Malha, vice president, neuromodulation, Abbott.