Laboratory and clinical reliability of conformally coated subretinal implants

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• 作者：Renate Daschner ; Udo Greppmaier ; Martin Kokelmann ; Sandra Rudorf…
• 关键词：Electronic implants ; Clinical reliability ; Artificial vision ; Neuroprosthetics ; Retinitis pigmentosa
• 刊名：Biomedical Microdevices
• 出版年：2017
• 出版时间：March 2017
• 年：2017
• 卷：19
• 期：1
• 全文大小：1170KB
• 刊物类别：Engineering
• 刊物主题：Biomedical Engineering; Biological and Medical Physics, Biophysics; Nanotechnology; Engineering Fluid Dynamics;
• 出版者：Springer US
• ISSN：1572-8781
• 卷排序：19

文摘

Despite recent developments and new treatments in ophthalmology there is nothing available to cure retinal degenerations like Retinitis Pigmentosa (RP) yet. One of the most advanced approaches to treat people that have gone blind due to RP is to replace the function of the degenerated photoreceptors by a microelectronic neuroprosthetic device. Basically, this subretinal active implant transforms the incoming light into electric pulses to stimulate the remaining cells of the retina. The functional time of such devices is a crucial aspect. In this paper the laboratory and clinical reliability of the two active subretinal implants Alpha IMS and Alpha AMS is presented. Based on clinical data the median operating life of the Alpha AMS is estimated to be 3.3 years with a one-sided lower 75 % confidence level of 2.0 years. This data shows a significant improvement of the device lifetime compared to the previous device Alpha IMS which shows a median lifetime of 0.6 years with a lower confidence bound (75 %) of 0.5 years. The results are in good agreement with laboratory data from accelerated aging tests of the implant components, showing an estimated median lifetime for Alpha IMS components of 0.7 years compared to the improved lifetime of Alpha AMS of 4.7 years.