The professor of neurology provided insight into the field of deep brain stimulation and how Abbott's recent FDA approval is a solid step forward.
Michele Tagliati, MD
On Thursday, the FDA gave Abbott’s Infinity Deep Brain Stimulator (DBS) systems approval for an over-the-air upgrade that includes many new features, including the ability to upgrade the device via a Bluetooth connection, and the delivery of magnetic resonance (MR)-condition labeling.
While the MRI adaptability catches the Infinity DBS up to the rest of the class of stimulators, the wireless upgrading feature grants the system a real leg up from the field. To find out more about what this means for DBS as a while, NeurologyLive spoke with Michele Tagliati, MD, the Caron and Steven D. Broidy Chair in Movement Disorders, vice chairman of the Department of Neurology, and director of the Movement Disorders Program at Cedars-Sinai, in Los Angeles.
The professor of neurology has long been familiar with the device—and DBS devices as a whole—he was a co-author on a 2012 study of it in patients with Parkinson disease. When speaking with NeurologyLive, he admitted that now, though, it is much more evolved and has improved greatly from what he worked with in the past.
Michele Tagliati, MD: The ability to be able to upgrade the software without needing to change the device raises the bar for the standards of DBS quality. It used to be that if you wanted a new ability or upgrade, you needed to put a whole new device in. Now, we have a system that can be upgraded, and quality features can be added without needing to change the device—that’s a huge advancement for providers, and for the quality of life for the patient.
[Here,] they’ve also added the Bluetooth compatibility, so we don’t have to have a wire attached to the patient or a wand, or anything that acts as a physical restraint—you couldn’t test patients while they were walking or moving. This idea that you can upgrade or change the software is a truly a sign of progress that’s made this device much more flexible. If we find a problem, that can be corrected without having to take everything off and putting it back. I’d like to stress that.
The MRI feature puts the Abbott device on par with other DBS devices. That’s perceived as a possible obstacle to the implant, as MRI can be needed at any time and you can’t predict when that will be. So, having it compatible makes it more accessible for prescribers.
MT: We’ve been using DBS for many, many years, and there’s been slowness of innovation as a whole—what we’ve had have always been hardware changes.
They have added a number of features to DBS [systems in general] that are quite important, including the segmented leads that allow us to be directional, to stay away from areas that may cause unwanted adverse effects.
Ultimately, when everything goes well, DBS is DBS. It’s going to work well. What we deal with because of implantation—things may be slightly right or slightly left—is flexibility. It’s the need for troubleshooting when you have a problem. Having a segmented lead, to adjust the electricity and the direction, that gives us a lot of flexibility.
The Bluetooth capability makes the interaction with a patient more comfortable and it makes more sense. The flexibility of this ability to upgrade the system, essentially as needed, is amazing. It’s truly an advancement that makes sense. There are many things we can do with DBS, but this is definitely a strong step forward. Again, this concept kind of raises the bar and makes it the new bare minimum.
MT: I think that many still believe DBS is experimental. It’s established for Parkinson disease and medication-resistant dystonia and tremor. It was approved in 1998 for tremor—we’re talking 20 years ago—and then in 2002-2003 for Parkinson.
This approval enhances our ability to use it, but ultimately this is an established treatment. The idea is that we’re working on enhancement of something that should be considered and available for the appropriate patients. In my mind, that’s how it is.
Every movement doctor would say that this is pretty well established. Many patients with Parkinson disease are treated now by internists and general neurologists, and they may be much less aware of this as an option. With general neurologists, you may find varying levels of understanding.
[The thing is,] there is still surgery required. That’s the biggest obstacle, no question. But having larger flexibility with good outcomes may make it more available—at least at a knowledge level, with providers being familiar with the true potential of the device. All these improvements are a way to make people aware of it. It’s getting better and better.
Transcript edited for clarity.
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