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）作爲全球眼科醫療領導者，致力於幫助人們明亮地看到世界。今天宣佈，UNITY玻璃體視網膜白內障系統（VCS）和UNITY白內障系統（CS）已獲得美國食品和藥物管理局（FDA）510（k）許可。這些創新是Alcon備受期待的Unity系列中首批推出的產品。
"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，我們有一個悠久的歷史，一直秉承與客戶共同參與研發的傳統，致力於在眼科醫療領域帶來創新。我們要感謝那些在Alcon取得今天里程碑成就時幫助我們的人，”Alcon全球研發負責人兼首席科學官Franck Leveiller表示。“我們很高興能夠推出下一代設備解決方案和消耗品——在白內障和玻璃體視網膜手術方面——幫助眼科醫療專業人士和患者獲得實際的益處。”
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當前市場領先的產品CONSTELLATION玻璃體視網膜手術系統和CENTURION具有ACTIVE SENTRY的白內障手術系統，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."
“我一直密切參與Unity VCS和Unity CS的研發；這款真正創新的系統是Alcon最優秀技術的重大升級，”史蒂夫·查爾斯（Steve Charles），MD，FACS，FICS，FASRS表示。“慶祝獲得這家偉大公司的批准是一種自豪。”
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
預計全球將進行3100萬次白內障手術，到2029年這個數字預計將增加到3700萬。全球估計將進行約220萬次玻璃體切割手術。2,3 Alcon是白內障和視網膜手術包（每次手術使用的消耗品）的全球市場領導者。
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，市場上有超過28000個Centurion和Constellation設備，未來十年將有目標將其升級到Unity平台。除了系統外，Unity VCS和Unity CS還帶來了首款面向市場的技術和消耗品，旨在爲外科醫生、工作人員和患者帶來顯着的好處。
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已經通過與來自30多個國家的200多位高度經驗豐富的外科醫生進行的調查諮詢實驗室測試了Unity VCS和Unity CS。現在獲得了510（k）許可，Alcon將開始一個全面的計劃，以在2025年商業化發佈之前獲得現實世界的反饋。今年晚些時候，在全球各個市場將繼續進行監管提交。預計CE標誌將於2025年初獲得。
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的最新創新產品——這是一系列創新產品的組合，旨在幫助眼科醫療專業人士提高臨床和手術室效率，並提供卓越的患者體驗。Alcon願景套件將繼續增長，預計在未來幾年內推出前沿的Unity產品，同時繼續提供市場領先的遺產產品，並提供服務。Unity VCS和Unity CS將得到Alcon培訓、產品維護和服務團隊的支持。
Cautionary Note Regarding Forward-Looking Statements
關於前瞻性聲明的謹慎說明
譯文內容由第三人軟體翻譯。