Retinal implant wins FDA approval

The U.S. Food and Drug Administration (FDA) approved the Argus II retinal prosthesis system for use in the United States.

Mark Humayun, who holds joint appointments at the Keck School of Medicine of USC and the USC Viterbi School of Engineering, was a key member of the team that developed the device, which will be available to qualified patients at the Keck Medical Center of USC.

The Argus II, which received a unanimous recommendation for approval by the FDA’s Ophthalmic Devices Advisory Panel in September, restores some visual capabilities for patients whose blindness is caused by Retinitis Pigmentosa (RP), an inherited retinal degenerative disease that affects about 100,000 people nationwide.

“It is incredibly exciting to have FDA approval to begin implanting the Argus II and provide some restoration of vision to patients blinded from RP,” said Humayun, Cornelius Pings Professor of Biomedical Sciences and professor of ophthalmology, biomedical engineering, cell and neurobiology at USC. “In the patients that have been implanted to date, the improvement in the quality of life has been invaluable.

“The fact that many patients can use the Argus implant in their activities of daily living, such as recognizing large letters, locating the position of objects and more, has been beyond our wildest dreams,” Humayun added, “yet the promise to the patients is real, and we expect it only to improve over time.”

The Argus II, which is manufactured by Sylmar, Calif.-based Second Sight, was approved for use in Europe in 2011 and has been implanted in 30 patients in a clinical trial that began in 2007. Humayun performed many of the surgeries to implant the device.

The FDA approval paves the way for Second Sight to build a surgical network in the United States to implant the device, as well as to recruit hospitals to offer it, according to Robert Greensburg, president and CEO of the company.

The Argus II system uses a camera mounted on special glasses that sends a signal to an electronic receiver with 60 electrodes implanted inside the eye.

The receiver sends signals to the retina that travel through the optic nerve to the brain, where they can be interpreted as a visual picture. The researchers hope that one day the device can be improved to also help individuals with age-related macular degeneration, a similar but far more common disease.

Public inquiries regarding the Argus II can be directed to the Second Sight public information line at (855) 756-3703.

As the Argus II retinal implant is refined, it will be housed in the USC Institute of Biomedical Therapeutics. The new $60 million endowed interdisciplinary institute will bring together scientists, engineers and clinicians from around the world to study neural networks to develop bioelectronic solutions for the millions of people impacted by traumatic brain injury, stroke and debilitating eye diseases.

FDA Approves Clinical Trial of Auditory Brainstem Implant Procedure for Children in the U.S.

L.A.-based House Research Institute and Children’s Hospital Los Angeles announced today that the United States Food and Drug Administration (FDA) has given final approval to begin a clinical trial of an Auditory Brainstem Implant (ABI) procedure for children. The trial is a surgical collaboration sponsored by the House Research Institute in partnership with Children’s Hospital Los Angeles and Vittorio Colletti, MD of the University of Verona Hospital, Verona, Italy.

The ABI was developed at the House Research Institute and is the world’s first successful prosthetic hearing device to stimulate neurons directly at the human brainstem, bypassing the inner ear and hearing nerve entirely. Since the procedure began, more than 1,000 adults worldwide have received the ABI, with surgeons at the House Clinic leading the way.

“This will be the first FDA-approved trial of its kind, and represents a major step forward to bring a sense of hearing to deaf children in the U.S. who are born without a hearing nerve or cochlea (hearing organ) and therefore are unable to benefit from hearing aids or cochlear implants,” said Neil Segil, Ph.D, executive vice president for research, House Research Institute. “Since its development at the House Research Institute in 1979 by Drs. William House and William Hitselberger, the ABI has been successful in providing a sense of sound to many adults in the U.S., however it has never been approved by the FDA for treating deafness in children. This study has the potential to expand the use of this remarkable device, which represents the only effective sensory prosthetic for direct brain stimulation in use today.”

The Pediatric ABI team includes physicians and researchers from the House Research Institute, including Eric Wilkinson, MD, Laurie Eisenberg, Ph.D., Robert Shannon, Ph.D.; Marc Schwartz, MD; Laurel Fisher, Ph.D.; Steve Otto, M.A., and Margaret Winter, M.S., as well as Children’s Hospital Los Angeles’ Mark Krieger, MD and Gordon McComb, MD; and Verona Hospital’s Vittorio Colletti, MD; Marco Carner, MD; and Liliana Colletti, Ph.D.

“We’re excited to have reached this milestone and look forward to being able to offer this amazing technology to children in the United States who currently have no other option for hearing rehabilitation,” said Eric Wilkinson, MD, co-principal investigator and lead physician for the clinical trial.

Robot Allows ‘Remote Presence’ in Programming Brain and Spine Stimulators

With the rapidly expanding use of brain and spinal cord stimulation therapy (neuromodulation), new “remote presence” technologies may help to meet the demand for experts to perform stimulator programming, reports a study in the January issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The preliminary study by Dr. Ivar Mendez of Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, Canada, supports the feasibility and safety of using a remote presence robot—called the “RP-7”—to increase access to specialists qualified to program the brain and spine stimulators used in neuromodulation.

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(Image: NEUROSURGERY® Editorial Office)

New implant replaces impaired middle ear

Functionally deaf patients can gain normal hearing with a new implant that replaces the middle ear. The unique invention from the Chalmers University of Technology has been approved for a clinical study. The first operation was performed on a patient in December 2012.

With the new hearing implant, developed at Chalmers in collaboration with Sahlgrenska University Hospital in Gothenburg, the patient has an operation to insert an implant slightly less than six centimetres long just behind the ear, under the skin and attached to the skull bone itself. The new technique uses the skull bone to transmit sound vibrations to the inner ear, so-called bone conduction.

“You hear 50 percent of your own voice through bone conduction, so you perceive this sound as quite natural”, says Professor Bo Håkansson, of the Department of Signals and Systems, Chalmers.

The new implant, BCI (Bone Conduction Implant), was developed by Bo Håkansson and his team of researchers. Unlike the type of bone-conduction device used today, the new hearing implant does not need to be anchored in the skull bone using a titanium screw through the skin. The patient has no need to fear losing the screw and there is no risk of skin infections arising around the fixing.

The first operation was performed on 5 December 2012 by Måns Eeg-Olofsson, Senior Physician at Sahlgrenska University Hospital, Gothenburg, and went entirely according to plan.

“Once the implant was in place, we tested its function and everything seems to be working as intended so far. Now, the wound needs to heal for six weeks before we can turn the hearing sound processor on”, says Måns Eeg-Olofsson, who has been in charge of the medical aspects of the project for the past two years.

The technique has been designed to treat mechanical hearing loss in individuals who have been affected by chronic inflammation of the outer or middle ear, or bone disease, or who have congenital malformations of the outer ear, auditory canal or middle ear. Such people often have major problems with their hearing. Normal hearing aids, which compensate for neurological problems in the inner ear, rarely work for them. On the other hand, bone-anchored devices often provide a dramatic improvement.

In addition, the new device may also help people with impaired inner ear. “Patients can probably have a neural impairment of down to 30-40 dB even in the cochlea. We are going to try to establish how much of an impairment can be tolerated through this clinical study”, says Bo Håkansson.

If the technique works, patients have even more to gain. Earlier tests indicate that the volume may be around 5 decibels higher and the quality of sound at high frequencies will be better with BCI than with previous bone-anchored techniques. Now it’s soon time to activate the first patient’s implant, and adapt it to the patient’s hearing and wishes. Then hearing tests and checks will be performed roughly every three months until a year after the operation.

“At that point, we will end the process with a final X-ray examination and final hearing tests. If we get good early indications we will continue operating other patients during this spring already”, says Måns Eeg-Olofsson.

The researchers anticipate being able to present the first clinical results in early 2013. But when will the bone-conduction implant be ready for regular patients?

“According to our plans, it could happen within a year or two. For the new technique to quickly achieve widespread use, major investments are needed right now, at the development stage”, says Bo Håkansson.

Will we ever… have cyborg brains?

For the first time in over 15 years, Cathy Hutchinson brought a coffee to her lips and smiled. Cathy had suffered from the paralysing effects of a stroke, but when neurosurgeons implanted tiny recording devices in her brain, she could use her thought patterns to guide a robot arm that delivered her hot drink. This week, it was reported that Jan Scheuermann, who is paralysed from the neck down, could grasp and move a variety of objects by controlling a robotic arm with her mind.

In both cases the implants convert brain signals into digital commands that a robotic device can follow. It’s a remarkable achievement, one that could transform the lives of people debilitated through illness.

Yet it’s still a far cry from the visions of man fused with machine, or cyborgs, that grace computer games or sci-fi. The dream is to create the type of brain augmentations we see in fiction that provide cyborgs with advantages or superhuman powers. But the ones being made in the lab only aim to restore lost functionality – whether it’s brain implants that restore limb control, or cochlear implants for hearing.

Creating implants that improve cognitive capabilities, such as an enhanced vision “gadget” that can be taken from a shelf and plugged into our brain, or implants that can restore or enhance brain function is understandably a much tougher task. But some research groups are being to make some inroads.

For instance, neuroscientists Matti Mintz from Tel Aviv University and Paul Verschure from Universitat Pompeu Fabra in Barcelona, Spain, are trying to develop an implantable chip that can restore lost movement through the ability to learn new motor functions, rather than regaining limb control. Verschure’s team has developed a mathematical model that mimics the flow of signals in the cerebellum, the region of the brain that plays an important role in movement control. The researchers programmed this model onto a circuit and connected it with electrodes to a rat’s brain. If they tried to teach the rat a conditioned motor reflex – to blink its eye when it sensed an air puff – while its cerebellum was “switched off” by being anaesthetised, it couldn’t respond. But when the team switched the chip on, this recorded the signal from the air puff, processed it, and sent electrical impulses to the rat’s motor neurons. The rat blinked, and the effect lasted even after it woke up.

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Human Eye Gives Researchers Visionary Design for New, More Natural Lens Technology

Drawing heavily upon nature for inspiration, a team of researchers has created a new artificial lens that is nearly identical to the natural lens of the human eye. This innovative lens, which is made up of thousands of nanoscale polymer layers, may one day provide a more natural performance in implantable lenses to replace damaged or diseased human eye lenses, as well as consumer vision products; it also may lead to superior ground and aerial surveillance technology.

This work, which the Case Western Reserve University, Rose-Hulman Institute of Technology, U.S. Naval Research Laboratory, and PolymerPlus team describes in the Optical Society’s (OSA) open-access journal Optics Express, also provides a new material approach for fabricating synthetic polymer lenses.

The fundamental technology behind this new lens is called “GRIN” or gradient refractive index optics. In GRIN, light gets bent, or refracted, by varying degrees as it passes through a lens or other transparent material. This is in contrast to traditional lenses, like those found in optical telescopes and microscopes, which use their surface shape or single index of refraction to bend light one way or another.

“The human eye is a GRIN lens,” said Michael Ponting, polymer scientist and president of PolymerPlus, an Ohio-based Case Western Reserve spinoff launched in 2010. “As light passes from the front of the human eye lens to the back, light rays are refracted by varying degrees. It’s a very efficient means of controlling the pathway of light without relying on complicated optics, and one that we attempted to mimic.”

People plus: is transhumanism the next stage in our evolution?

Inviting artificial intelligence into our bodies has appeal – but it also carries certain risks.

I have often wondered what it would be like to rid myself of a keyboard for data entry, and a computer screen for display. Some of my greatest moments of reflection are when I am in the car driving long distances, cooking in my kitchen, watching the kids play at the park, waiting for a doctor’s appointment or on a plane thousands of metres above sea level.

I have always been great at multitasking but at these times it is often not practical or convenient to be head down typing on a laptop, tablet or smartphone.

It would be much easier if I could just make a mental note to record an idea and have it recorded, there and then. And who wouldn’t want the ability to “jack into” all the world’s knowledge sources in an instant via a network?

Who wouldn’t want instant access to their life-pages filled with all those memorable occasions? Or even the ability to slow down the process of ageing, as long as living longer equated to living with mind and body fully intact, as outlined in the video.

Transhumanists would have us believe that these things are not only possible but inevitable. In short: we Homo sapiens may dictate the next stage of our evolution through our use of technology.

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Artificial cornea gives the gift of vision

Blindness is often caused by corneal diseases. The established treatment is a corneal transplant, but in many cases this is not possible and donor corneas are often hard to come by. In the future, an artificial cornea could make up for this deficiency and save the vision of those affected.

“We are in the process of developing two different types of artificial corneas. One of them can be used as an alternative to a donor cornea in cases where the patient would not tolerate a donor cornea, let alone the issue of donor material shortage,” says IAP project manager Dr. Joachim Storsberg.

The scientist has considerable expertise in developing and testing of next-generation biomaterials. Between 2005 and 2009 he collaborated with interdisciplinary teams and private companies to successfully develop an artificial cornea specifically for patients whose cornea had become clouded – a condition that is extremely difficult to treat. Such patients are unable to accept a donor cornea either due to their illness or because they have already been through several unsuccessful transplantation attempts. Dr. Storsberg was awarded the Josef-von-Fraunhofer Prize 2010 for this achievement. “A great many patients suffering from a range of conditions will be able to benefit from our new implant, which we’ve named ArtCornea®. We have already registered ArtCornea® as a trademark,” reports Storsberg.

You, robot?

Technology and regulation: A research project considers how the law should deal with technologies that blur man and machine

SPEAKING at a conference organised by The Economist earlier this year, Hugh Herr, a roboticist at the Massachusetts Institute of Technology, described disabilities as conditions that persist “because of poor technology” and made the bold claim that during the 21st century disability would be largely eliminated. What gave his words added force was that half way through his speech, after ten minutes of strolling around the stage, he unexpectedly pulled up his trouser legs to reveal his bionic legs, and then danced a little jig. In future, he suggested, people might choose to replace an arthritic, painful limb with a fully functional robotic one. “Why wouldn’t you replace it?” he asked. “We’re going to see a lot of unusual situations like that.”

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