First Patient Receives FDA-Approved Telescope Implant For End-Stage Macular Degeneration
Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Nov 2011 - 1:00 PST
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VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, today announced that the first patient has received the FDA-approved Implantable Miniature Telescope (by Dr. Isaac Lipshitz) procedure indicated to improve vision in patients with end-stage age-related macular degeneration (AMD). The first patient was evaluated by and received the telescope implant procedure from ophthalmologists Henry L. Hudson, M.D., retinal specialist at Retina Centers, P.C., and Kristin Carter, M.D., anterior segment eye surgeon, both part of the CentraSight™ provider team in Tucson, AZ. The procedure was performed on an outpatient basis at Carondelet Health Network's St. Joseph's Hospital in Tucson.
This first procedure marks the launch of VisionCare's CentraSight treatment program, a new patient care program utilizing the first-of-kind telescope implant for treating patients with the most advanced form of AMD and the leading cause of blindness in older Americans, end-stage AMD. Regional CentraSight Centers of Excellence - multidisciplinary healthcare provider teams trained in patient evaluation, surgical treatment, and visual rehabilitation - are beginning to treat patients this month.
"Our patient's procedure is a milestone that brings new hope and a first treatment option for our most visually debilitated AMD patients," said Dr. Hudson, who was a principal investigator in the pivotal trial for FDA approval and lead author of the trial outcomes publications. "Patients with end-stage AMD have been underserved, and they have had limited options until now. Our patients who have exhausted all wet AMD treatment options, or who have the untreatable, advanced form of dry AMD, now have a potential for improved vision and quality of life. We're talking more than just seeing better on the eye chart, but about being more independent in their daily activities and reconnecting with their social network of friends, family, and their community."
"It is really wonderful that the telescope implant is now available," said Dr. Carter, also a clinical investigator during the pivotal trial. "Implanting this micro-optical device so patients can regain many of the visual-related activities they were no longer able to do after losing their central vision can be life-changing for the patient, and is gratifying to me as a surgeon."
Noridian Administrative Services, Medicare's Administrative Contractor for Arizona, was the first Medicare contractor to cover the telescope implant procedure for Medicare beneficiaries visually impaired by end-stage AMD. Other Medicare regional contractors have also begun covering the telescope procedure for eligible patients.
"We are excited to be working with the ophthalmic community to bring the implantable telescope technology to eligible AMD patients living with central blindness," said Allen W. Hill, CEO of VisionCare. "We are grateful to the clinical trial investigators who demonstrated the safety and efficacy of the treatment, and the scientists, our employees, and the array of organizations who have helped bring this treatment to market."
The telescope implant is designed to improve visual acuity. The magnification provided by the implant reduces the impact of the blind spot caused by end-stage AMD. End-stage AMD causes severe to profound central vision loss in both eyes due to either wet AMD that has progressed to scarring of the macula despite drug treatments, or dry AMD that has progressed to geographic atrophy, the most advanced form of dry AMD.
Results from the two U.S. clinical trials, conducted at 28 leading ophthalmic centers, have been published in peer-reviewed scientific journals including Ophthalmology, American Journal of Ophthalmology, and Archives of Ophthalmology. Most recently, in September's issue of Ophthalmology, a study reports the intraocular telescope improves quality of life and is cost effective.
visioncare眼科技术，公司，开发先进的视觉假体装置，今天宣布，第一个病人已收到美国食品药物管理局批准的植入式微型望远镜（博士艾萨克李普希茨）程序表明改善视力患者的终末期年龄相关性黄斑变性（公司）。第一个病人进行了评估和接收望远镜植入手术的眼科医生··哈得逊，医学博士，视网膜专家在视网膜中心，电脑，和克里斯廷·卡特，医学博士，前部分眼外科医生的一部分，centrasight™供应商团队在图森，亚利桑那州。这一程序上进行门诊在绿色食品卫生网络的圣约瑟夫医院在图森。这一程序是visioncarecentrasight推出的治疗计划，一个新的病人护理计划利用first-of-kind望远镜植入治疗最先进的形式，和失明的主要原因老年人，终末期和。区域centrasight卓越中心-多学科的医疗服务队训练的病人评价，手术治疗，及视觉康复-开始治疗这个月。“我们的病人的程序是一个里程碑，带来新的希望和一个治疗选择我们最直观的衰弱和病人，说：”哈德森医生，谁是主要研究者在关键的审判，美国食品及药物管理局批准并导致作者的试验结果的出版物。”患者的终末期超微一直不足，和他们有限制的选项，直到现在。我们的病人谁已用尽所有湿和治疗方案，或有不治之症，先进形式的干，现在有一个潜在的改善视力和生活质量。我们谈论的不仅仅只是看到更好的视力表上的，而是更独立的日常活动和重新与他们的社会网络的朋友，家人，和他们的社区。”“这真是奇妙的望远镜植入现已，”卡特，也是临床调查员在关键的审判。”植入这种微光学装置使患者能恢复视觉有关的活动的许多他们不再能做后失去他们的中央视力可以改变生活的病人，并很高兴我作为一个外科医生。”noridian行政服务，医疗保险的管理承包商亚利桑那州，是第一个医疗保险公司支付望远镜植入手术的医疗保险受益人的终末期及视障。其他医疗区域承包商也开始涵盖望远镜程序符合条件的患者。“我们很高兴能与眼科界带来植入望远镜技术资格和患者的中央失明，说：”艾伦·山，visioncare首席执行官。”我们感谢临床试验调查谁证明的安全性和疗效的治疗，和科学家，我们的员工，以及阵列的组织有助于将这种治疗市场。”望远镜植入的目的是改善视力。放大提供了植入的影响减少盲点造成的终末期和。终末期和造成严重的深刻中央视力丧失双眼由于湿，进展疤痕黄斑尽管药物治疗，或干，发展地理萎缩，最先进的形式，干燥和。结果从美国临床试验，进行了28个领先的眼科中心，已发表在同行评审的科学期刊包括眼科，眼科杂志，和眼科学档案。最近，在九月出版的眼科的眼内望远镜，研究报告改善生活质量和成本效益。 |
