Medtronic plc has won the U.S. FDA’s nod for the first deep brain stimulation (DBS) system that integrates Brainsense, the company’s technology to sense and record brain signals for more personalized treatment. The next-generation Percept PC DBS with Brainsense is approved to treat symptoms associated with Parkinson’s disease, essential tremor, dystonia, epilepsy and obsessive-compulsive disorder. The approvals for dystonia and OCD are under a humanitarian device exemption, while the others are full premarket approvals.

“There is nothing that can replace clinical judgment in treating patients,” said Mike Daly, vice president and general manager of Dublin-based Medtronic’s Brain Modulation business. “For the first time, this technology gives clinicians feedback directly from the DBS patient’s brain. With such data-driven, patient-specific insights, we believe it can change the standard of care.”

The system, which received CE marking in January, is expected to see its first U.S. implant at Mayo Clinic in Rochester, Minn., in early July.

Next-gen enhancements

Steven Goetz, senior engineer and strategist in Medtronic's Brain Modulation business

The ability to adjust patient treatment based on individual data, coupled with a 15% longer battery life and the ability to remain in place during both 3T and 1.5T full-body MRI scans, are expected to set it apart from other DBS systems available in the market. “This is important because the enhanced signal quality in the higher-strength 3T scanners is very important in seeing the features of the brain needed to practice DBS successfully, and so we are excited about this significant enhancement in our offering,” Steven Goetz, a senior engineer and strategist in the Brain Modulation business, told BioWorld.

Other new features include low pulse width, giving patients and their doctors a broader range of stimulation options, and an enhanced patient programmer that allows patients to manage their therapy via a user-friendly, custom-configured Samsung mobile device.

“We were very excited that the Mayo Clinic was willing to be involved in bringing this new technology to the market,” Goetz said. “The team there has been fully trained on the new technology and have a patient identified, and so everything appears to be on track.”

Bryan Klassen, a neurologist at Mayo Clinic, said the goal is to enable patients to regain some of their independence, and it’s known DBS “can significantly improve motor function in people with Parkinson’s disease compared to standard medication alone.” With this latest Percept version, physicians “can now more precisely tailor therapy to the individual needs of each patient based on data from neuronal activity,” he said.

The total DBS market in the U.S. is estimated at about $400 million, representing new and existing patients whose systems require replacement after the battery life ended. Goetz said all new patients and those returning for replacements will receive the new Percept device. In some rare cases, physicians may choose to proactively upgrade patients to the new device if they believe the new capabilities of Percept would benefit the patient’s specific clinical challenges.

To date, Medtronic has implanted more than 175,000 DBS systems worldwide.

With CE marking earlier this year, the Percept PC with Brainsense technology is being marketed across Europe, and clinicians have implanted the system in all five of the currently indicated patient populations. “The European launch was well underway as COVID-19 began to slow elective procedures, but we saw high levels of excitement and adoption prior to that slowdown,” Goetz said.

The company is now working to expand access to Percept in other geographies, including Japan, Canada and Australia.

Looking to close the loop

For Medtronic, the Percept PC neurostimulator is an early milestone on the path toward closed-loop deep brain stimulation. “This device has more latent capability – features hidden or locked at launch – than any that we have developed,” Goetz said. A key opportunity is the “adaptive” or closed-loop stimulation capability, where certain measures of brain activity would be used to adjust the therapy as the patient’s symptoms change.

“If indeed these features work as we hope, the promise is to deliver therapy that is truly tailored to the patient’s fluctuating disease state 24/7 – like a personal neurologist following the patient all day and night to ensure her or his device is always working optimally at all times,” Goetz said.

With FDA approval of Percept PC in hand, Medtronic plans to submit an IDE for a pivotal trial to support the use of adaptive capabilities, to launch later this year.

Brain modulation is part of Medtronic’s Restorative Therapies Group. For the fourth quarter of fiscal year 2020, sales declined 32% from the same period the prior year, to $7.73 billion, due to the deferment of procedures during the COVID-19 pandemic. Revenue from brain therapies dropped 26% to $615 million, reflecting high 30s declines in DBS, as well as high 20s declines in neurosurgery and high single-digit declines in neurovascular.

The damp fourth-quarter results contrasted with the previous quarter, which recorded a 4.2% increase in brain modulation, to $2.11 billion from $2.03 billion in Q3 FY19. The third-quarter growth was led by high single-digit growth in brain therapies.

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