Alcon Receives FDA Clearance for Revolutionary Cataract and Vitreoretinal Systems
Alcon Receives FDA Clearance for Revolutionary Cataract and Vitreoretinal Systems
Alcon (NYSE:ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that UNITY Vitreoretinal Cataract System (VCS) and UNITY Cataract System (CS) have received U.S. Food and Drug Administration (FDA) 510(k) clearance. These innovations are the first to be introduced from Alcon's highly anticipated Unity portfolio.
Alcon（NYSE: ALC）作为全球眼科医疗领导者，致力于帮助人们明亮地看到世界。今天宣布，UNITY玻璃体视网膜白内障系统（VCS）和UNITY白内障系统（CS）已获得美国食品和药物管理局（FDA）510（k）许可。这些创新是Alcon备受期待的Unity系列中首批推出的产品。
"At Alcon, we have a long legacy of involving our customers throughout the research and development process to deliver bold innovation in ophthalmology, and we would like to thank those who helped us arrive at today's milestone," said Franck Leveiller, Head of Global R&D and Chief Scientific Officer, Alcon. "We are excited to introduce the next generation of equipment solutions and consumables—in cataract and vitreoretinal surgery—and deliver meaningful impact for Eye Care Professionals and patients."
“在Alcon，我们有一个悠久的历史，一直秉承与客户共同参与研发的传统，致力于在眼科医疗领域带来创新。我们要感谢那些在Alcon取得今天里程碑成就时帮助我们的人，”Alcon全球研发负责人兼首席科学官Franck Leveiller表示。“我们很高兴能够推出下一代设备解决方案和消耗品——在白内障和玻璃体视网膜手术方面——帮助眼科医疗专业人士和患者获得实际的益处。”
Unity VCS and Unity CS introduce significant workflow efficiencies over Alcon's current market-leading systems, CONSTELLATION Vision System for vitreoretinal procedures and CENTURION Vision System with ACTIVE SENTRY for cataract surgery.
Unity VCS和Unity CS相比Alcon当前市场领先的产品CONSTELLATION玻璃体视网膜手术系统和CENTURION具有ACTIVE SENTRY的白内障手术系统，具有更高的工作效率。
"I have been closely involved in the development of Unity VCS and Unity CS; this truly innovative system is a significant upgrade of Alcon's best-in-class technologies," said Steve Charles, MD, FACS, FICS, FASRS. "It is a proud moment to be able to celebrate this clearance."
“我一直密切参与Unity VCS和Unity CS的研发；这款真正创新的系统是Alcon最优秀技术的重大升级，”史蒂夫·查尔斯（Steve Charles），MD，FACS，FICS，FASRS表示。“庆祝获得这家伟大公司的批准是一种自豪。”
Worldwide, there will be an estimated 31 million cataract surgeries in 2024, and that number is expected to increase to 37 million by 2029.1 There will be approximately 2.2 million vitrectomy procedures in 2024 across the globe.2 Alcon is the global market leader for cataract and retina procedural packs (consumables used in each surgery).2,3
预计全球将进行3100万次白内障手术，到2029年这个数字预计将增加到3700万。全球估计将进行约220万次玻璃体切割手术。2,3 Alcon是白内障和视网膜手术包（每次手术使用的消耗品）的全球市场领导者。
Today, there are more than 28,000 Centurion and Constellation devices in the market that will be targeted for upgrade to the Unity platform over the next decade. In addition to the system, Unity VCS and Unity CS bring first-to-market technologies and consumables that are designed to drive significant benefits for the surgeon, staff and patients.
目前，市场上有超过28000个Centurion和Constellation设备，未来十年将有目标将其升级到Unity平台。除了系统外，Unity VCS和Unity CS还带来了首款面向市场的技术和消耗品，旨在为外科医生、工作人员和患者带来显着的好处。
Alcon has tested Unity VCS and Unity CS during investigational advisory wet lab sessions with more than 200 highly experienced surgeons from 30+ countries. Now with 510(k) clearance, Alcon will begin a thorough program to secure real-world feedback before commercial launch in 2025. Regulatory submissions will continue later this year in markets across the globe. CE Mark is expected in early 2025.
Alcon已经通过与来自30多个国家的200多位高度经验丰富的外科医生进行的调查咨询实验室测试了Unity VCS和Unity CS。现在获得了510（k）许可，Alcon将开始一个全面的计划，以在2025年商业化发布之前获得现实世界的反馈。今年晚些时候，在全球各个市场将继续进行监管提交。预计CE标志将于2025年初获得。
Unity VCS and Unity CS are the latest innovations from the Alcon Vision Suite—a portfolio of innovative products designed to help Eye Care Professionals increase clinic and OR efficiency, and deliver exceptional patient experiences. The Alcon Vision Suite will continue to grow with cutting-edge Unity products expected to be introduced over the coming years, adding to our market-leading legacy products which will continue to be available and serviceable. Unity VCS and Unity CS will be supported by Alcon's training, product maintenance and Services teams.
Unity VCS和Unity CS是Alcon Vision Suite的最新创新产品——这是一系列创新产品的组合，旨在帮助眼科医疗专业人士提高临床和手术室效率，并提供卓越的患者体验。Alcon愿景套件将继续增长，预计在未来几年内推出前沿的Unity产品，同时继续提供市场领先的遗产产品，并提供服务。Unity VCS和Unity CS将得到Alcon培训、产品维护和服务团队的支持。
Cautionary Note Regarding Forward-Looking Statements
关于前瞻性声明的谨慎说明