Study Says Argus "Bionic" Eye Safe

"The three-year clinical trial results of the retinal implant popularly known as the 'bionic eye,' have proven the long-term efficacy, safety and reliability of the device that restores vision in those blinded by a rare, degenerative eye disease," according to Medical News Today. "The findings show that the Argus II significantly improves visual function and quality of life for people blinded by retinitis pigmentosa. They are being published online today in Ophthalmology, the journal of the American Academy of Ophthalmology." Read more.

Surgeons in Hawaii Implant Bionic Retinal Device

The Argus II "bionic eye implant has the potential to restore vision to patients, who have been in total or near total darkness."

"Groundbreaking bionic retinal implant surgery has been performed in Honolulu by a team at the Eye Surgery Center of Hawaii. The procedure is the first of its kind in the Asia-Pacific region to help restore vision for the blind," according to a Medical News Today post. "The team of doctors, led by Dr. Gregg T. Kokame, completed the cutting-edge procedure on March 24, 2015. Dr. Mark Humayu, Prof. of Ophthalmology at the University of Southern California (USC) Eye Institute, Los Angeles, CA and the co-inventor of the Argus II implant was also present for this historic event." Read more.

Two RP Patients Receive Argus II Implants

Two newly approved centers, located in Camposampiero and Florence, have completed their first commercial implants of the Argus II Retinal Prosthesis System (Argus II), says the system's manufacturer, Second Sight Medical Products, Inc. The patients are suffering from outer retinal degeneration.

Outer retinal degeneration is the deterioration of the outer layer of the retina caused by progressive death of the cells in this region of the retina. An important type of outer retinal degeneration is Retinitis Pigmentosa (RP). To date, surgeons have implanted the specialty lens in more than 100 individuals worldwide. The system stimulates the remaining cells of the retina with electrical pulses. These firing cells create light patterns in the brain. The company says these images help with such daily activities as recognizing shapes and large objects, locating people, identifying the location of doorways, and following lines or edges.

The treatment is offered at approved centers in Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, Turkey, United Kingdom, and the United States. Read more.

Study Demonstrats the Promise of Argus II for Nearly Blind

"Research presented today at the 117th Annual Meeting of the American Academy of Ophthalmology shows promising data about a device that helps people who have lost their vision due to a blinding genetic disease to recognize common objects," according to a Science Daily post. "In the study, the researchers found when the objects' outlines had been enhanced, there was increased recognition. The device, called the Argus II, is the first FDA-approved retinal implant for adults with retinitis pigmentosa. Retinitis pigmentosa is a group of genetic disorders that affect the retina's ability to respond to light. The disease, which is inherited and affects about 1 in 4,000 Americans, causes slow loss of vision, beginning with decreased night vision and loss of peripheral vision and eventually leads to blindness. Up to one-quarter of all patients with retinitis pigmentosa will become legally blind in both eyes. There is currently no cure for retinitis pigmentosa." Read more.

Popular Science  recently named it invention of the year.  See our post. 

Argus Named 'Invention of the Year'

Popular Science has recognized the Argus II Retinal Prosthesis System from Second Sight Medical Products, Inc., as ‘Invention of the Year.’ Each year, its editors review thousands of products in search of the top 100 innovations that represent a significant leap in their categories. Argus converts video images captured by a miniature camera housed in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses reportedly stimulate the retina’s remaining cells, resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function.

"Bionic Eye" Argus II Offered in a Dozen U.S. Markets

The Argus II Retinal Prosthesis System (“Argus II”) will be initially offered in 12 major markets across the U.S. to treat patients with late stage retinitis pigmentosa (RP), according to a spokesperson for its manufacturer, Second Sight Medical Products, Inc.. This news follows U.S. market approval for the Argus II by the Food and Drug Administration (FDA) in this past February. The device is a “bionic eye.” Implant centers, based in hospitals in Ann Arbor, Atlanta, Baltimore, Chicago, Cleveland, Dallas, Durham, Los Angeles, Miami, Nashville, Philadelphia, and San Francisco--will accept consultations for patients with RP. Read more.

FDA Approves ‘Bionic Eye’ for Patients with Retinitis Pigmentosa

“An implanted, sight-enhancing device some are calling a ‘bionic eye’ is the first to gain approval for use in the United States,” according to a Midwest Lens post. “According to the U.S. Food and Drug Administration, the new Argus II Retinal Prosthesis System can help patients with a genetic eye disease called retinitis pigmentosa regain some sense of vision. About 100,000 Americans are believed to be affected by the illness, which causes a gradual deterioration of the eyes’ photoreceptor cells.” Read more.

FDA Approves Argus II for RP

After more than 20 years of research and development, the Food and Drug Administration has approved the Argus II retinal prosthesis system for the treatment of alte stage retinitis pigmentosa. That's the word from Second Sight Medical Products, Inc., which spent more than two decades researching the product. The FDA's actions follow receipt of the European approval in 2011 and a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012. The company says that the product provides electrical stimulation of the retina to induce visual perception individuals blinded by retinitis pigmentosa. Although the resulting vision is not the same as when these patients had normal vision, investigators involved in the clinical trial of the Argus II are eager about the approval. Read more.

Here's a more detailed article in the New York Times: "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. The device allows people with a certain type of blindness to detect crosswalks on the street, the presence of people or cars, and sometimes even large numbers or letters. The approval of the system marks a 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. ...The artificial retina is a sheet of electrodes implanted in the eye. The patient is also given glasses with an attached camera and a portable video processor. This system, called Argus II, allows visual signals to bypass the damaged portion of the retina and be transmitted to the brain.” Read more.

Braille Patterns Streamed Directly to Retina

"For the very first time researchers have streamed braille patterns directly into a blind patient's retina, allowing him to read four-letter words accurately and quickly with an ocular neuroprosthetic device. The device, the Argus II, has been implanted in over 50 patients, many of who can now see color, movement and objects. It uses a small camera mounted on a pair of glasses, a portable processor to translate the signal from the camera into electrical stimulation, and a microchip with electrodes implanted directly on the retina," according to Science Daily. "The study was authored by researchers at Second Sight, the company who developed the device, and has been published in Frontiers in Neuroprosthetics on the 22nd of November." Read more.

Prosthesis Helps Blind See Motion

A study recently published online, and set to be issued in the February print edition of the peer-reviewed journal, Archives of Ophthalmology, demonstrated that the Argus II Retinal Prosthesis System enabled a majority of blind participants, implanted with the device, to identify the direction of moving objects better with the Argus II on than off. This journal article is the latest in a series of publications that shows that the Argus II restores some visual function to patients blinded by retinitis pigmentosa (RP), and that this function translates into real benefits in everyday life. Last month, an FDA Ophthalmic Devices Advisory Panel voted unanimously that the probable benefit of the Argus II outweighs the risks to health, clearing the way for regulatory approval in the US. The Argus II system has been approved for use in the European Economic Area and is on the market in several European countries since last year and remains the only approved retinal implant anywhere in the world. Read more.