Significance of Medtronic’s DBS System Approved for Asleep Neurosurgery

Ashwini Sharan, MD

In early August, the FDA granted approval to Medtronic’s deep brain stimulation (DBS) system to be used to treat patients with Parkinson disease (PD) and essential tremor while they are asleep. With the decision, it became the first and only company to receive such approval to offer DBS surgery under both asleep and awake circumstances, allowing for greater treatment opportunities and flexibility.

Asleep DBS offers several advantages over traditional awake procedures. It eliminates the need for patient participation during surgery, reducing anxiety and discomfort. This can be especially beneficial for patients who may have difficulty remaining still or responding accurately while awake. In addition, the procedure allows for the use of advanced imaging techniques, such as intraoperative MRI or CT, which provide precise, real-time guidance, potentially enhancing accuracy in electrode placement.

Following the approval of the asleep DBS, NeurologyLive® reached out to Ashwini Sharan, MD, chief medical officer of Medtronic Neuromodulation, for comment. Sharan, who also serves as the co-director of the Neuro Restoration center at Thomas Jefferson University, spoke on what the new MRI labeling adds to the systems, the ways in which DBS have evolved over the years, and potential for further expansion and opportunities to treat patients with movement disorders.

NeurologyLive: What does this new MRI labeling add to Medtronic’s DBS systems? How does this impact clinical care?

Ashwini Sharan, MD: The Medtronic DBS MRI Advantage is second to none. Percept™ PC and RC neurostimulator batteries are designed to allow DBS therapy to remain ON during an MRI scan. Percept™ is the only 3T and 1.5T MR Conditional directional DBS system, allowing DBS to remain ON during MRI scans. The safety of the Percept™ family for MRI is backed by 14 years of rigorous MRI research and testing, including 38,000 scan conditions and 10 million simulated patient scans.

And now our best-in class MRI labeling is even stronger. The MRI labeling approval, exclusive to Medtronic Deep Brain Stimulation (DBS) systems, allows additional active scan time for scans below specified B1+rms limits, increasing the options available for diagnostic and functional assessments. Only Medtronic DBS systems can continue therapy ON in bipolar mode, under certain conditions, while a patient is having an MRI scan. The updated labeling to remove the 30-minute active scan restriction, along with the Medtronic exclusive 3T MRI capability, provides patients with truly uncomplicated MRI access.

Over the years, how have the DBS systems evolved for the better?

Medtronic has earned its reputation as an originator and world-leading innovator in Brain Modulation thanks to a commitment to continuous innovation of our therapy. It all started with our work with French doctors leading to the first DBS STN implant, in Grenoble, in 1987.

Medtronic is transforming Brain Modulation through sensing-enabled DBS. Medtronic has the only DBS system with sensing, directionality, advanced programming providing insights-informed, personalized care. Our exclusive BrainSense™ technology continuously collects brain signal data to provide a window into patients’ condition, in real time, and over time. BrainSense™ uses local field data to provide unique, data-driven insights into each patient’s condition, inside and outside the clinic (including responses to DBS therapy and medications), enabling clinicians to adapt DBS to a patient’s evolving needs. Our BrainSense™ technology is also engineered for future software upgrades that allow existing and future patients to have access to additional features without a device exchange.

In January 2024, we launched the new Percept™ RC rechargeable neurostimulator. Percept™ RC is the smallest and thinnest dual channel neurostimulator available for DBS. It is equipped with BrainSense™ technology that captures and records brain signals to provide insights that enable a healthcare provider to adapt and personalize therapy to a patient's evolving needs. Unlike other rechargeable devices, the Percept™ RC battery offers at least 15 years of service life with consistent and fast recharge performance. Medtronic’s patented battery technology has less battery fade than other rechargeable devices for a more reliable, long-lasting battery. Patients can experience rapid recharging from 10% to 90% full charge in less than an hour.

In July 2024, we received FDA approval for Asleep DBS. Medtronic is the first and only company to offer DBS therapy approved for surgery while a patient is asleep (under general anesthesia) or awake. Fear of awake surgery can be a major barrier for patients considering DBS as a treatment option. We know that people with Parkinson’s disease who choose Asleep DBS achieve improved motor symptoms on par with Awake DBS. This is a significant advancement of our surgical offering, providing another safe and effective option for patients considering DBS.

Is Medtronic looking to expand the DBS systems even further? Any ideas or thoughts on what that would look like?

We have made huge leaps in recent years, from DBS Originator to World-leading Innovator with new technologies and capabilities to transform Brain Modulation through sensing-enabled DBS. We are future-ready and adapting for what’s next with the goal of many more patients’ lives changed with Medtronic DBS.