Shots: 

• Erika spoke about the FDA Breakthrough Device Designation received by Abbott to investigate its deep brain stimulation (DBS) system to treat treatment-resistant depression (TRD)
• Erika also talked about how NeuroSphere Virtual Clinic is compatible with the  deep brain stimulation (DBS) system 
• The interview gives an understanding of Abbott’s vision to bring life-changing technologies in the field of diagnostics, medical devices, nutritional and generic medicines

Smriti: Explain Abbott’s DBS system and how it works. How could this system prove to be a treatment option for treatment-resistant depression (TRD)? 

Erika Ross: Abbott’s deep brain stimulation (DBS) system is a personalized, adjustable therapy that works by implanting thin wires – or leads – into targeted areas of the brain. A pulse generator (or battery) implanted under the skin in the chest is connected to the leads and produces electrical impulses that can modulate abnormal brain activity. Patients with treatment-resistant depression (TRD) who have failed to respond to four different antidepressant approaches have few remaining options available to them. Stimulation therapy, such as Abbott’s DBS system, could represent a potential new application to provide better care for those living with TRD and enhance a person’s quality of life.

Smriti: Shed some light on the studies and trials that led you to believe the DBS system could help people with TRD. What led to the FDA BTD?  

Erika Ross: Abbott received Breakthrough Device Designation by demonstrating its DBS system could potentially provide more effective treatment for people who have not responded to multiple depression therapies. Abbott is actively working with the FDA to develop a plan for evaluating the device’s safety and effectiveness for this purpose. Breakthrough Device Designation given by the U.S. FDA provides priority review of technologies that can improve the lives of people with life-threatening or debilitating diseases or conditions. 

Smriti: How is the DBS system currently used with NeuroSphere Virtual Clinic? Would it be used the same way for TRD? 

Erika Ross: Abbott’s NeuroSphere Virtual Clinic is a first-of-its-kind technology in the U.S. that allows patients to communicate with, and receive stimulation settings from, their physicians in real-time and remotely via the cloud and Bluetooth-based technology. The NeuroSphere Virtual Clinic is currently compatible with Abbott's suite of neuromodulation technologies, including the Infinity™ DBS System for patients with Parkinson’s disease and tremors of the upper extremities in adults with essential tremors. If approved by the FDA for use in TRD, Abbott’s DBS system has the potential to have similar digital care administered through Abbott’s NeuroSphere Virtual Clinic platform.

Smriti: Please share some more details about your plan to evaluate the safety and effectiveness of the device for treatment-resistant depression.

Erika Ross: Abbott is excited about exploring the possibilities that DBS treatment could potentially have on people living with TRD. We will continue to work with regulatory agencies to determine the process and next steps necessary to build the evidence base needed for a decision on approval. The team is working tirelessly to identify the next steps and best design for our upcoming clinical study plan that will meet the needs of the FDA and other regulatory agencies in determining the safety and effectiveness of this therapy in this population of people with this chronic disease.

Smriti: Are there other devices/treatments that you are developing in your pipeline for the same indication?

Erika Ross: Abbott is focused on helping patients and their doctors make better, faster and more complete decisions about their health in ways that easily fit within their lives. The company is leading the development of life-changing and patient-friendly technologies in the management of chronic pain and movement disorders through patient-centric innovations like NeuroSphere™ myPath™. The NeuroSphere myPath app gives people the ability to track, analyze and report on pain relief and general well-being associated with their pain management. Abbott’s investments over the past decade in technology and remote monitoring have paid off for patients, especially during the COVID-19 pandemic, which increased demand for digital and telehealth platforms. Abbott will continue to drive the field forward to improve how physicians address pain and movement disorders well into the future.

Source: Canva

About the Author:

Dr. Erika Ross is the Director of Clinical & Applied Research at Abbott She is responsible for leading the applied research strategy for Abbott’s neuromodulation business, including managing its product development and external partnerships. Dr. Ross has areas of expertise in neurostimulation, digital health, bio-wearables, data science, neuroscience, and neural engineering. Dr. Ross completed her bachelor of science in biology, neuroscience, and master of science in molecular biology at the University of Denver. She completed her Ph.D. in neuroscience studying deep brain stimulation at the Mayo Clinic.
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