Tuesday, January 16, 2018
Health

FDA okays artificial retina that gives limited vision to the blind

The Food and Drug Administration on Thursday approved the first treatment to give limited vision to people who are blind, involving a technology called the "artificial retina."

With it, people with certain types of blindness can detect crosswalks on the street, burners on a stove, the presence of people or cars, and sometimes even oversized numbers or letters.

The artificial retina is a sheet of electrodes surgically implanted in the eye. The patient is also outfitted with a pair of glasses with an attached camera and a portable video processor. These elements together allow visual signals to bypass the damaged portion of the retina and be transmitted to the brain. The FDA approval covers this integrated system, which the manufacturer calls Argus II.

The approval marks the first milestone in a new frontier in vision research, a field in which scientists are making strides with gene therapy, optogenetics, stem cells and other strategies.

"This is just the beginning," said Grace Shen, director of the retinal diseases program at the National Eye Institute, which helped finance the artificial retina research and is supporting many other blindness therapy projects.

With the artificial retina or retinal prosthesis, a blind person cannot see in the conventional sense but can identify outlines and boundaries of objects, especially when there is contrast between light and dark.

"Without the system, I wouldn't be able to see anything at all, and if you were in front of me and you moved left and right, I'm not going to realize any of this," said Elias Konstantopolous, 74, a retired electrician in Baltimore, one of about 50 Americans and Europeans who have been using the device in clinical trials.

He said it helps him differentiate curbs from asphalt roads and detect contours, but not details, of cars, trees and people.

The FDA approved Argus II, made by Second Sight Medical Products, to treat people with severe retinitis pigmentosa, a group of inherited diseases in which photoreceptor cells, which take in light, deteriorate.

The first version of the implant had a sheet of 16 electrodes, but the current version has 60. A tiny camera mounted on eyeglasses captures images, and the video processor, worn on a belt, translates those images into pixelized patterns of light and dark. The processor transmits those signals to the electrodes, which send them along the optic nerve to the brain.

About 100,000 Americans have retinitis pigmentosa, but initially between 10,000 and 15,000 will likely qualify for the Argus II, according to the company. The FDA says that up to 4,000 people a year can be treated with the device. That number represents people older than 25, who once had useful vision, have evidence of an intact inner retinal layer, have at best very limited light perception and are so visually impaired that the device would prove an improvement. Second Sight will begin making Argus II available later this year.

But experts said the technology holds promise for other people who are blind, especially those with advanced age-related macular degeneration, the major cause of vision loss in older people, affecting about 2 million Americans. About 50,000 of them are currently severely impaired enough that the artificial retina would be helpful, said Dr. Robert Greenberg, Second Sight's president and chief executive. Additional clinical trials need to be completed before the company can seek broader FDA approval.

Eventually, Greenberg said, the plan is to implant electrodes not in the eye but directly into the brain's visual cortex.

Initially, the artificial retina will be available in five states: New York, California, Texas, Maryland and Pennsylvania. It will cost about $150,000, not including the surgery and training sessions to use the device. Second Sight said it was optimistic that insurance would cover it.

Comments
Pinellas is at the center of a rise in Florida flu outbreaks

Pinellas is at the center of a rise in Florida flu outbreaks

Feeling a little sniffly or scratchy or stuffed up? It may be the flu, and you don’t want to wait around to see a doctor this year. This is not the time to write off flu-like symptoms, Tampa Bay area health officials and doctors warn. The influenza v...
Updated: 6 hours ago

CDC says ‘There’s lots of flu in lots of places.’ And it’s not going away anytime soon.

A nasty flu season is in full swing across the United States, with a sharp increase in the number of older people and young children being hospitalized, federal health officials said Friday.The latest weekly data from the Centers for Disease Control ...
Published: 01/12/18
Mease Countryside Hospital begins $156M expansion project

Mease Countryside Hospital begins $156M expansion project

SAFETY HARBOR — Mease Countryside Hospital is launching a $156 million expansion to build a four-story patient tower with all private rooms and a four-story parking garage.The tower will include 70 private patient rooms, a 30-bed observation unit, cr...
Published: 01/11/18
Flu shot? This is why you should still get one this year

Flu shot? This is why you should still get one this year

This year’s flu season is shaping up to be a bad one. Much of the country endured a bitterly cold stretch, causing more people to be crowded together inside. The strain that has been most pervasive, H3N2, is nastier than most. And, we’re being told, ...
Published: 01/11/18
He was 21 and fit. He tried to push through the flu — and it killed him.

He was 21 and fit. He tried to push through the flu — and it killed him.

Kyler Baughman seemed to be the face of fitness. The 21-year-old aspiring personal trainer filled his Facebook page with photos of himself riding motorbikes and lifting weights. He once posted an image of a kettlebell with a skeleton, reading: "Cros...
Published: 01/11/18
Serena Williams tells scary story of childbirth complications

Serena Williams tells scary story of childbirth complications

The image on the cover of the February issue of Vogue features Serena Williams proudly showing off her adorable daughter.The story she tells of the changes wrought on her life by the arrival of Alexis Olympia, whom she calls by her middle name and ...
Published: 01/11/18
‘Pregnancy centers’ draw scrutiny as lawmakers seek to elevate their status

‘Pregnancy centers’ draw scrutiny as lawmakers seek to elevate their status

Annie Filkowski used to see the signs during her drive to school each morning. "Free pregnancy tests," they said.So when she feared she might be pregnant at 16, shortly after starting to have sex with her boyfriend, she remembered them. And walked in...
Published: 01/10/18
Updated: 01/12/18
Analysis: St. Petersburg ranked among 'worst places to die'

Analysis: St. Petersburg ranked among 'worst places to die'

Where do you want to die? When asked, the vast majority of Americans answer with two words: "At home." Despite living in a country that delivers some of the best health care in the world, we often settle for end-of-life care that is inconsistent wit...
Published: 01/10/18
Obamacare enrollment remained strong in Florida, despite obstacles

Obamacare enrollment remained strong in Florida, despite obstacles

While health insurance sign-ups through the Affordable Care Act dipped slightly across the nation for 2018, Floridians bought plans at nearly the same levels as last year despite a much shorter enrollment period, a smaller budget for promotion and re...
Published: 01/10/18
Defending against this season’s deadly flu: 5 things to know

Defending against this season’s deadly flu: 5 things to know

The nation is having a Terrible, Horrible, No Good, Very Bad flu season.Flu is widespread in 46 states, according to reports to the U.S. Centers for Disease Control and Prevention (CDC).Nationally, as of mid-December, at least 106 people had died fro...
Published: 01/09/18