Rayner closes recruitment for IDE for RayOne EMV Toric IOLs
Posted on 27/06/2024
Rayner, a global manufacturer of products for cataract surgery based in Worthing, UK, is delighted to announce that it has now closed recruitment in the Investigational Device Exemption (IDE) study for the EMV Toric Intraocular lens in the USA.
The study reflects Rayner’s continued focus on optimising visual outcomes for surgeons and their patients and will ultimately enable the introduction of the RayOne EMV Toric lens for use in the USA. Developed in collaboration with Professor Graham Barrett, RayOne EMV’s truly non-diffractive optic utilises positive spherical aberration to extend vision on the rotationally stable RayOne toric platform.1
Jim Nevelos PhD, Head of Global Clinical at Rayner, commented “Closing recruitment on this study is a huge milestone for us. All patients will have their final follow ups well before the end of the year and the PMA submission will follow that. This IDE will allow us to complete our range of the highly clinically successful RayOne EMV platform in the USA.”
After receiving news of the recruitment closure, Dr James Fox from ICON Eyecare in Grand Junction, CO commented, “We are proud to be the number one enrolling site for this pivotal study. Our clinical experience with this lens has been excellent and we are excited to help this study progress to PMA and ultimately approval by the FDA.”
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1 Bhogal-Bhamra GK, Sheppard AL, Kolli S, Wolffsohn JS. J Refract Surg. 2019;35(1):48-53.
About Rayner:
Since the implantation of the first Rayner intraocular lens by Sir Harold Ridley 1949, Rayner has had 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.
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.
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