Rayner announces first RayOne Galaxy implantations in the US
Posted on 1/10/2024
Rayner, a global manufacturer of products for cataract surgery based in Worthing, UK, announces today that it has successfully implanted the first lenses in the RayOne Galaxy IOL U.S. Food and Drug Administration (FDA) approved Investigational Device Exemption (IDE) Study. The study is prospective, multicenter, randomised, masked and active controlled. If successful, the results of the study are intended to allow a Pre-Market Approval (PMA) submission to the FDA.
The first implantations mark the start of an exciting journey with RayOne Galaxy for Rayner in the United States, enabling the organization to continue driving its focus on optimizing visual outcomes for surgeons and their patients around the world.
Rayner’s Head of Global Clinical, Jim Nevelos PhD commented “The first implants in the IDE study are a huge milestone for this novel, spiral IOL and are aligned with our plans to expand our product offering in the USA. This comes just a few weeks after the successful European launch at the recent ESCRS meeting.”
Vance Thompson (Vance Thompson Vision, SD) performed the first implantation in the study, quickly followed by Dr James Fox (Icon Eyecare, CO) who also implanted the first Galaxy lens in the USA. All surgeons are thrilled to be a part of the study, with Dr Thompson commenting: “We have been eagerly awaiting the opportunity to implant this new IOL. The early experience in Europe has been very encouraging and we now get to collect detailed clinical performance data in this IDE. The first case went very well, and we look forward to collecting the clinical outcomes.”
About Rayner:
Since the implantation of the first Rayner intraocular lens by Sir Harold Ridley 1949, Rayner has the goal to improve vision and restore sight worldwide. Today, Rayner’s mission remains to deliver innovative and clinically superior ophthalmic products that respond to the expectations of our global customers to improve the sight and quality of life of their patients.
Headquartered in Worthing, United Kingdom, Rayner markets its medical devices, pharmaceuticals, and digital solutions worldwide in over 80 countries through a network of distributors and includes direct sales teams in the United Kingdom, Eire, USA, Canada, Brazil, India, Poland, Australia, Germany, Austria, Switzerland, France, Italy, Spain, and Portugal.
The RayOne Galaxy intraocular lens is currently under trial investigation and has not yet received FDA approval for commercial sale in the United States. Participation in the clinical study is subject to specific eligibility criteria, and potential risks associated with the device may apply.
Not all Rayner products are approved for sale in every country. Please contact your local Rayner distributor for details of which products are available in your area.
©2024 Rayner Group, all rights reserved. ‘Rayner’, ‘RayOne’ and ‘Galaxy’ are proprietary marks of the Rayner Group. All other trademarks are property of their respective owners.
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