gizmag.com
Argus II becomes first "bionic eye" to gain approval for sale in U.S.
By Noel McKeegan
February 18, 2013
While the word prosthesis usually evokes images of artificial legs, arms, and these days even sophisticated thought-controlled hands, an entirely new class of replacement body part has now become a reality – the bionic eye. One of the pioneers in this field is California-based Second Sight and the company has now announced that its Argus II System has received U.S. market approval from the Food and Drug Administration (FDA).
The result of two decades of R&D and US$200 million in public and private investment, the Argus II System began clinical trials in the U.S. back in 2007 and won approval for sale in Europe in 2011.
The system is designed to treat near blindness caused by retinitis pigmentosa – a degenerative disease said to affect approximately 100,000 Americans. It consists of a tiny video camera mounted in glasses that is wirelessly linked to a receiver and microelectrode array implanted onto the patient's retina. This microelectrode array, which spans 20 degrees of the visual field, then stimulates the remaining cells in the retina with electrical pulses that travel down the optic nerve to the brain. While it does not restore normal sight, patients can learn to interpret these signals and gain a significant increase in visual capabilities to the point where they can perceive colors, recognize large letters and locate objects.
“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. In the patients that have been implanted to date, the improvement in the quality of life has been invaluable,” said Mark Humayun, MD, PhD, Cornelius Ping’s Professor of Biomedical Engineering, Professor of Ophthalmology, Biomedical Engineering, Cell and Neurobiology, Doheny Eye Institute at University of Southern California. “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, yet the promise to the patients is real and we expect it only to improve over time.”
The Argus II is expected to become available later this year. “With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant," said Robert Greenberg, MD, PhD, President and CEO of Second Sight.
The Second Sight video below runs us through how the Argus II system works.
Source: Second Sight
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2012-08-20
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自由時報：劉文泰人工視網膜第二代作用方式
2013-2-20
歐美已有10多個成功案例／劉文泰研發人工視網膜 美核准上市
〔記者洪美秀／竹市報導〕交大傑出校友劉文泰教授經廿多年努力，投入研究的人工視網膜「阿格斯第二 代系統（Argus II system）」，十四日通過美國聯邦食品暨藥物管理局（ＦＤＡ）核准植入人眼，將造福因視網膜病變失明患者重現光明，目前在美國、歐洲已有十幾個成功案 例。第二代技術可辨識到人臉及字體，解析度大為提升，手術價格約三百萬台幣。
可辨識人臉、字體 手術費約300萬元
交大表示，劉文泰團隊在美國核准上市的產品「阿格斯第二代系統」是一種視網膜人工電子眼的系統裝 置。患者透過眼鏡上的照相機捕捉影像，傳送到隨身配戴的處理器，處理之後的訊號回傳眼鏡，經由天線無線傳輸給患者植入的人工視網膜上的電極陣列晶片。晶片 隨之將其轉換為電波，經由視神經傳遞給大腦對應到視覺影像，進而讓人感受到影像。
交大表示，阿格斯第二代系統這項裝置手術只需一個多小時， 除改善阿格斯第一代體積較大的缺點外，最重要的是人工視網膜的電子眼從有線變無線，且可由植入的發電器自體發電，但需由專業合格的眼科醫師操刀，目前在台 灣還未被核准，也無醫院取得這項手術認證，裝設這套人工視網膜晶片需近十萬美元（約三百萬台幣）。
交大表示，這套系統可造福因視網膜病變而 失明的患者，在美國每四千人就有一人因此病變失明，未來患者植入人工電子眼後，可看到物品的位置輪廓，還可偵測到移動、改善方向感及行動技巧。另因色素性 視網膜炎或老年性黃斑病變失去視覺的病患，也可經由手術，安裝人工視網膜後恢復部分視覺。
交大將爭取在台核准植入人體
交 大表示，二○○七年發表的阿格斯第一代，系統成像效果為十六畫素，但第二代可有六十四畫素，可辨識人臉及字體，解析度大為提升，且是以無線電波方式傳輸， 手術時間也縮短，風險大為降低。美國盲人歌手史蒂夫汪達也參與臨床試驗，據說史蒂夫本人感覺不錯，可看到某些影像。未來校方會邀請劉文泰教授回台灣發表這 項研究，並爭取在台灣核准植入人體的機會。
February 18, 2013
 |
| Argus II consists of a tiny video camera mounted in glasses that is wirelessly linked to a receiver and microelectrode array implanted onto the patient's retina |
While the word prosthesis usually evokes images of artificial legs, arms, and these days even sophisticated thought-controlled hands, an entirely new class of replacement body part has now become a reality – the bionic eye. One of the pioneers in this field is California-based Second Sight and the company has now announced that its Argus II System has received U.S. market approval from the Food and Drug Administration (FDA).
The result of two decades of R&D and US$200 million in public and private investment, the Argus II System began clinical trials in the U.S. back in 2007 and won approval for sale in Europe in 2011.
The system is designed to treat near blindness caused by retinitis pigmentosa – a degenerative disease said to affect approximately 100,000 Americans. It consists of a tiny video camera mounted in glasses that is wirelessly linked to a receiver and microelectrode array implanted onto the patient's retina. This microelectrode array, which spans 20 degrees of the visual field, then stimulates the remaining cells in the retina with electrical pulses that travel down the optic nerve to the brain. While it does not restore normal sight, patients can learn to interpret these signals and gain a significant increase in visual capabilities to the point where they can perceive colors, recognize large letters and locate objects.
“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. In the patients that have been implanted to date, the improvement in the quality of life has been invaluable,” said Mark Humayun, MD, PhD, Cornelius Ping’s Professor of Biomedical Engineering, Professor of Ophthalmology, Biomedical Engineering, Cell and Neurobiology, Doheny Eye Institute at University of Southern California. “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, yet the promise to the patients is real and we expect it only to improve over time.”
The Argus II is expected to become available later this year. “With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant," said Robert Greenberg, MD, PhD, President and CEO of Second Sight.
The Second Sight video below runs us through how the Argus II system works.
Source: Second Sight
...........................................
2012-08-20
..................................................................
自由時報：劉文泰人工視網膜第二代作用方式
2013-2-20
歐美已有10多個成功案例／劉文泰研發人工視網膜 美核准上市
 |
| 交大校友劉文泰教授帶領團隊研發的人工視網膜第二代晶片，日前獲准在美國合法使用，可造福因視網膜病變的病人重見光明 |
〔記者洪美秀／竹市報導〕交大傑出校友劉文泰教授經廿多年努力，投入研究的人工視網膜「阿格斯第二 代系統（Argus II system）」，十四日通過美國聯邦食品暨藥物管理局（ＦＤＡ）核准植入人眼，將造福因視網膜病變失明患者重現光明，目前在美國、歐洲已有十幾個成功案 例。第二代技術可辨識到人臉及字體，解析度大為提升，手術價格約三百萬台幣。
可辨識人臉、字體 手術費約300萬元
交大表示，劉文泰團隊在美國核准上市的產品「阿格斯第二代系統」是一種視網膜人工電子眼的系統裝 置。患者透過眼鏡上的照相機捕捉影像，傳送到隨身配戴的處理器，處理之後的訊號回傳眼鏡，經由天線無線傳輸給患者植入的人工視網膜上的電極陣列晶片。晶片 隨之將其轉換為電波，經由視神經傳遞給大腦對應到視覺影像，進而讓人感受到影像。
交大表示，阿格斯第二代系統這項裝置手術只需一個多小時， 除改善阿格斯第一代體積較大的缺點外，最重要的是人工視網膜的電子眼從有線變無線，且可由植入的發電器自體發電，但需由專業合格的眼科醫師操刀，目前在台 灣還未被核准，也無醫院取得這項手術認證，裝設這套人工視網膜晶片需近十萬美元（約三百萬台幣）。
交大表示，這套系統可造福因視網膜病變而 失明的患者，在美國每四千人就有一人因此病變失明，未來患者植入人工電子眼後，可看到物品的位置輪廓，還可偵測到移動、改善方向感及行動技巧。另因色素性 視網膜炎或老年性黃斑病變失去視覺的病患，也可經由手術，安裝人工視網膜後恢復部分視覺。
交大將爭取在台核准植入人體
交 大表示，二○○七年發表的阿格斯第一代，系統成像效果為十六畫素，但第二代可有六十四畫素，可辨識人臉及字體，解析度大為提升，且是以無線電波方式傳輸， 手術時間也縮短，風險大為降低。美國盲人歌手史蒂夫汪達也參與臨床試驗，據說史蒂夫本人感覺不錯，可看到某些影像。未來校方會邀請劉文泰教授回台灣發表這 項研究，並爭取在台灣核准植入人體的機會。
