Q&A: Removing barriers to access key to expansion of DBS surgery for Parkinson’s

Key takeaways:

• Offering asleep or awake DBS aims to provide PD patients choice, impetus for choosing DBS therapy sooner.
• Individuals may become eligible for DBS procedures as soon as four years post diagnosis.

Deep brain stimulation (DBS) therapy has been a safe and effective treatment option for Parkinson’s disease for more than 30 years, but another surgical option for the therapy has emerged.

Healio spoke to Amaza Reitmeier, vice president and general manager of Medtronic, to find out what the future holds for DBS-related procedures, having received FDA approval for a version of the procedure where the patient is asleep.

Healio: What was the impetus to investigate asleep DBS surgery as a therapeutic option?

Reitmeier: Over the years, we have learned, a significant barrier for patients not wanting to get DBS surgery is fear of being awake during the procedure. As imaging techniques have improved, more physicians have begun using imaging to directly target the brain structures of interest. We did a comprehensive review of all available evidence to confirm that outcomes are similar whether a physician used imaging to target the structure and confirm lead location or Microelectrode Recording and test stimulation to confirm lead location. The available evidence for Medtronic devices confirmed that the outcomes are equivalent and based upon this information we submitted a labeling update to the FDA.

Healio: How was it developed with Medtronic Percept in mind?

Reitmeier: When a lead is well-placed, whether awake or asleep, Percept neurostimulators with our exclusive BrainSense technology are able to detect the brain signals that correlate with the presence or absence of symptoms of PD. Physicians are able to use BrainSense insights to better understand patients’ symptoms and adapt therapy for their personalized needs.

Healio: How does the recent FDA approval for the asleep version of the DBS surgery impact the future of its implementation for patients and clinicians?

Reitmeier: Our hope is that more patients who are eligible for DBS will choose to get the procedure sooner now that they have an on-label option for an asleep procedure. DBS for PD remains underpenetrated in the United States, even though it has been proven to be safe and extremely effective at controlling motor symptoms and fluctuations.

As soon as 4 years after diagnosis, patients may become eligible for the procedure, but too many people wait, often out of fear of the surgery. Our mission is to ensure that we remove barriers to accessing the therapy, and offering the option for an asleep procedure will hopefully mean that more people who could benefit from DBS choose to do so.

Healio: What does having a choice between asleep and awake procedures mean for those with motor function disorders?

Reitmeier: Treatment of Parkinson’s is complex. and many factors go into deciding what therapies are best for a patient. With both asleep and awake procedures now on-label for Medtronic devices, physicians have an additional on-label option to discuss with patients who may be eligible for DBS. We often hear from patients that they wish they had gotten the procedure sooner due to the benefits they experience. We hope that having the option will encourage more patients to choose DBS sooner.

Healio: What are Medtronic’s future plans with both asleep and awake DBS procedures which may lead to successful treatment of Parkinson’s disease and essential tremor?

Reitmeier: With the Percept family of neurostimulators and BrainSense technology, we are learning more than ever before about brain signals and how they may be used in the future to improve therapy for patients and improve workflows for the clinicians who treat them. Whether a patient has the procedure awake or asleep, our biggest motivation comes from knowing that people are getting the best possible therapy. Medtronic’s Percept devices with BrainSense technology offer unique insights to clinicians which translate into more personalized patient care.