https://www.fiercebiotech.com/medtech/second-sights-bionic-eyes-have-gone-obsolete-while-still-implanted-report-finds


‘Fantastic technology and a lousy company’: Second Sight’s ‘bionic eyes’ have gone obsolete while still implanted, report finds

By Andrea Park  Feb 17, 2022 08:48am

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The Argus II system was approved by the FDA in 2013 to treat late-stage retinitis pigmentosa. It provides a form of artificial vision by converting images into electrical pulses that the brain can then translate into a visual pattern of light. ((Getty Images))

Most new medical devices are designed to make their users’ day-to-day lives easier—but what happens when those devices are suddenly cut off from an initially promised level of support and technical upgrades?

The more than 350 people around the world who were implanted with Second Sight Medical’s Argus II retinal prosthesis over the course of the last decade are now finding out, according to an investigative report by IEEE Spectrum.

Second Sight began phasing out the Argus II in 2019, a process that quickly ramped up first because of dire financial issues that nearly wiped out the entire company, and then, just this month, because of a plan to shift gears and merge with drug delivery implant maker Nano Precision Medical.

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Amid this uncertainty, Argus II users say they’ve been left in the lurch. With upgrades and repairs no longer available, many patients are merely counting the days until their vision-restoring implants go dark.

“It is fantastic technology and a lousy company,” Ross Doerr, an Argus II patient, told Spectrum.

RELATED: Second Sight’s first patients receive its bionic eye

The Argus II system received European CE mark approval in 2011 and the FDA’s sign-off in 2013 to treat late-stage retinitis pigmentosa, a rare genetic eye disease that can cause a loss of sight.

The implant provides a form of artificial vision by collecting images through a tiny video camera attached to a pair of glasses. The system converts the images into electrical pulses to the retina, which the brain can then translate into a visual pattern of light, partially restoring a sense of functional vision.

Second Sight’s website promises that the device is “ever-improving” and offers Argus II users “the capacity for future hardware and software upgrades.”

According to the Spectrum report, however, it stopped offering upgrades in March 2020, when it announced that more than 80 of its 108 employees were being laid off ahead of an “orderly wind-down of the company’s operations.” Patients told the magazine the company didn’t inform them of this major update and that they had to find out about their implants’ imminent obsolescence second-hand.

By that time, Second Sight had already told patients of its intent to shift its focus from the Argus to the Orion implant, which is placed directly on the brain to provide artificial vision to patients with blindness caused by glaucoma, diabetic retinopathy, optic nerve injury, cancer or other conditions.

“We didn’t really support the basic Argus after that,” a former engineer at the company told Spectrum. “We didn’t sell any more, we didn’t make any more, we didn’t have anything to do with it anymore.”

And while Second Sight was able to step back from the brink of bankruptcy within a few months of the “wind-down” announcement, by then, the Argus system was further from its mind than ever. In November 2020, after Second Sight had already resumed studies of the Orion system, one Argus user’s video processing unit shattered, forcing him to crowdsource his own refurbished replacement.

RELATED: Second Sight eyes buyout of Nano Precision Medical and its diabetes drug implant

While the company is no longer offering repairs for the Argus implants, it told Spectrum in a statement that it has a limited number of external components available for replacements and continues to provide “virtual support” to physicians with patients using the system.

With neither replacement nor technical upgrades an option, Argus users are now forced to decide between two unattractive alternatives: They can either leave a soon-to-be-obsolete device in their eyes until it simply stops working—possibly leading to medical complications and MRI interference—or undergo a potentially risky and painful procedure to remove it.

In the meantime, Second Sight is moving increasingly further from the Argus system and possibly even the Orion system, which is still under development—opening yet another can of worms for clinical trial participants who have had the device implanted on their brains and now face an uncertain future.

The company announced this month its intent to merge with Nano Precision Medical, which makes devices that are implanted under the skin to deliver drugs for chronic diseases like diabetes and nonalcoholic steatohepatitis. Adam Mendelsohn, Ph.D., NPM’s CEO who has been tapped to lead the combined company, told Spectrum that it’ll focus largely on NPM’s portfolio, rather than Second Sight’s, and is “not committing to any sort of timeline with the Orion.”

While the new entity will attempt to do what is “right from an ethical perspective” regarding Second Sight’s existing devices, Mendelsohn noted that the company’s past is “simply not relevant to the new future.”

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