With significant advances in medical technology, implantable neurological devices such as deep brain, vagus nerve, and spinal cord stimulators are also becoming increasingly advanced. Neuralink, Elon Musk's wireless brain-computer interface (BCI), is one of his most well-known devices. China recently announced its own BCI implant, showing that it is rapidly catching up with the United States in neurotechnology.

Neuralink is one of the most famous neurotechnology companies
Neuralink is one of the most famous neurotechnology companies

Implanted neurotechnology devices have improved the quality of life for people living with neurological diseases. But given the rate of progress we're currently seeing, what if embedded neurotechnologies rapidly become obsolete? Or are they no longer receiving maintenance support from their manufacturers (if Windows is the operating system? Please consider discontinuing support for older versions of ). Can it be removed? If so, who will pay for it?

It boils down to: Should protection be put in place to cover these situations? Yes, some argue that it should. In a recently published paper, a study led by researchers at the Norman Fixel Institute for Neurological Disorders in Florida proposes a formal definition of “abandonment of implantable neurological devices.” They argue that this is important in developing guidelines, policies and laws related to transplantation. to implantable neurotechnical devices.

Neurotech implanted as part of clinical trial

In 2020, natural medicine reported the story of Rita Leggett, an Australian woman who received an experimental brain implant to treat epilepsy. The device, which was implanted as part of a clinical trial, worked for Leggett and stopped her from having seizures. However, the company that made the device, Neurovista, went bankrupt midway through testing as investors became uneasy about providing financial backing for such an invasive technology.

Since the company is no longer in business, there was no way to monitor the device. Quite literally, the battery died in Leggett's head (well, not completely, but the battery was supposed to last three years). Her husband offered to buy her a device from NeuroVista, but was rejected because of her proprietary components. Her only option was to have the device removed or “explanted.”

Spinal cord stimulation concept
Spinal cord stimulation concept

Frederick Gilbert, an associate professor at the University of Tasmania who specializes in the ethics of neurotechnology, said: Nature medicine According to the article, removing the device could be the same as discontinuing treatment. Gilbert said this is because these devices can have a significant impact on a patient's identity. The pain caused by device removal can be directly proportional to the effectiveness of the technique.

The authors of this study are of the view that clinical trial failure is not an abandonment of neurotechnical devices at first glance, as clinical trial failure may be primarily caused by safety concerns or lack of therapeutic efficacy. was formed. However, they said it is essential for those conducting clinical trials to meet three criteria to remain on the “right” side of the waiver. First, study participants should be informed about the possibility of discontinuation and being assigned to the treatment or control arm of the study. Second, participants must be informed if and when the trial will be discontinued. Finally, participants should be provided with resources for other treatments that meet accepted standards of care.

Of course, in addition to the problem of trials ending prematurely, there is also the question of what happens to neurotechnology implants when trials reach their natural conclusion. In such situations, participants are usually offered to remove the device. However, this is usually done after researchers have contacted public or private health insurance companies to see if they will cover the cost. There are currently no clear guidelines on whether to place or remove an implant.

Collapse of neurotech companies

The global market for neurotechnology products is expected to reach USD 17.1 billion in 2026. However, that does not guarantee that the companies that manufacture these products will survive. NeuroVista isn't the only neurotech company to close its doors to consumers.

In 2019, Autonomic Technologies (ATI) ceased operations after a successful placebo-controlled trial of a stimulator to treat cluster headaches. True, the company was shut down due to regulatory fraud, but the results for his 700+ people who used the device were the same. They did not have access to the proprietary software needed to recalibrate the device and maintain its effectiveness. Fortunately, Unity HA acquired his ATI intellectual property and received Breakthrough Device designation from the FDA in 2022.

A leading company in the field of implantable neurotechnology. Note: Neuralink is currently FDA approved for human testing.
A leading company in the field of implantable neurotechnology. Note: Neuralink is currently FDA approved for human testing.
Rachel Levy & Marisa Taylor/Reuters

Nuvectra, a maker of spinal cord stimulators for chronic pain, filed for bankruptcy in 2019. That same year, the prosthetic vision company Second Sight began draining funds and advised implant patients that it would stop producing retinal implants in order to focus on brain implants. Restores vision. In early 2020, the CEO and head of research and development abruptly resigned, most employees were laid off, the company began auctioning off its physical assets, and about 350 people with second-site implants were left wondering what's going on. I wondered. The company soon thereafter merged with Nano Precision Medicine (NPM). In mid-2020, Stimware, another maker of spinal cord stimulators, recalled all of its devices and filed for bankruptcy in 2022. There must be many more.

If these companies go out of business, the implants they create usually remain intact. In most cases, explant surgery is considered too expensive, too risky, or simply unnecessary. So for people with neurological conditions, it's back to square one, albeit with additional (and useless) hardware.

If you're lucky, you can find a replacement device. According to an article published in Nature In 2022, replacing outdated implants like Nuvectra's spinal cord stimulator will require surgery with weeks of recovery. Plus, it's expensive. The surgery and replacement device will cost approximately $40,000. This assumes a replacement device is available.

Device lifespan: To remove or not to remove?

As already mentioned, neurotechnology devices considered cutting-edge today may not be cutting-edge tomorrow. These devices have a built-in expiration date, at which point they will no longer function or be effective without ongoing maintenance and support.

In the summer of 2020, Elon Musk shared the latest progress on his Neuralink implant. Musk, who described the device as a “Fitbit for skulls,” was characteristically rude when describing the insertion process he envisions eventually being used on humans.

“Basically, you're opening up part of the skull,” he said. “Once we remove a coin-sized piece of skull, a robot inserts an electrode. Then a device replaces the part of the skull that was removed. And we basically seal it with superglue. That's how the wound closes, and you can walk around right after that. So cool.

Yeah, that's cool. But more interesting was the section of the presentation about Dorothy the pig who once had a Neuralink. Musk said removing Dorothy's implant demonstrated the “reversibility” of the device.

“What Dorothy shows is that with or without Neuralink, you can have a happy, healthy, indistinguishable pig,” Musk said.

That's all Musk has suggested about removing the devices. Nothing is said about the risks. A complete update on Neuralink progress in 2020 is available below.

Neuralink Progress Update, Summer 2020

Musk's brain implant company has since moved on from pigs and begun recruiting for its first human clinical trial. But first they had to fight with the FDA to get approval. Reuters reported in 2023 that the government agency had rejected the application for clinical trial approval citing patient safety, with particular concerns about how the device could be removed without damaging brain tissue. The FDA seems satisfied because it now has Musk's approval.

It is difficult to find expert commentary on whether removing Neuralink, or other brain implants, will damage the brain. To be fair to Musk, it may be unfair to speculate at this stage without human test subjects. But if implanting a device like Neuralink risks damaging brain tissue, it would be reasonable to assume that removing it would cause damage as well.

Definition of “Implantable Neurological Device Abandonment”

To inform the study, researchers reviewed the literature on neurological device abandonment before reaching a consensus on an appropriate definition. They propose adopting a standard definition consisting of either:

  1. Failure to provide information related to plans for medical, technical, and/or financial responsibility as a fundamental aspect of patient consent during and after clinical trials.
  2. Failure to meet reasonable obligations for medical, technical, and/or financial support prior to the end of the labeled useful life of the implantable device.
  3. Failure to address the immediate needs of individuals using implanted devices (such as infection or device reprogramming) may result in safety concerns and reduced device effectiveness.
  4. (1) Informed consent addresses continued access to and control of implantable devices (per 1 above) and/or other devices that may prove to be of equal or greater therapeutic value. (2) The study director has made reasonable efforts to facilitate continued access to and support for patients who would benefit from the device. do not have.

The issues raised in this article highlight the need for stronger and more consistent guidance in this rapidly evolving field to protect patients and their healthcare professionals.
“We believe that these doctrines we have enumerated so far will support further consideration and discussion toward a formal definition of abandonment of active implantable neurotechnical devices and the establishment of guidelines, policies, and laws to prevent its occurrence. “We believe this could provide a practical basis for dialogue,” the researchers said.

The study was published in the journal JAMA network open.

Source link