SIFI ANNOUNCES CERTIFICATION OF WELL FUSION® ACCORDING TO EU MDR

MINI WELL and MINI WELL PROXA are intended for primary implantation for visual correction of aphakia in adult patients (> 18 years old) with or without presbyopia after removal of a cataractous lens and of aphakia after refractive lensectomy in presbyopic adults who desire spectacle independence for distance, intermediate and near vision. MINI WELL and MINI WELL PROXA are intended for primary implantation for visual correction of aphakia in adult patients (> 18 years old) with or without...

MINI WELL and MINI WELL PROXA are intended for primary implantation for visual correction of aphakia in adult patients (> 18 years old) with or without presbyopia after removal of a cataractous lens and of aphakia after refractive lensectomy in presbyopic adults who desire spectacle independence for distance, intermediate and near vision.

Mini WELL and Mini WELL PROXA are designed to be implanted binocularly to create WELL FUSION® a unique optical system specifically designed to deliver uninterrupted high-quality vision at all distances and in all lighting conditions. The two intraocular lenses have complementary designs and share the same extended depth of focus (EDOF) platform based on the distribution of wavefront aberrations in the central zone of the optics, a SIFI proprietary and patented technology.

"We are pleased to reach such a regulatory milestone, ensuring patients will continue to have access to WELL FUSION® beyond the regulatory transition period in Europe." stated Fabrizio Chines, SIFI Chairman and CEO "The clinical evidence generated since 2021 confirmed that our pioneering and patented technology effectively delivers uninterrupted high-quality vision at all distances after cataract surgery and refractive lens exchange, meeting the stricter requirements of the EU MDR."

ABOUT MDR: Regulation (EU) 2017/745 is the new regulation of the European Union on the clinical investigation and sale of medical devices for human use. It replaced Directive 93/42/EEC (MDD) and Directive 90/385/EEC on 26 May 2021 with the aim of raising product quality and safety standards.

ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, focusing on eye care since 1935. SIFI develops, manufactures, and markets innovative therapeutic solutions for patients with ophthalmic conditions. SIFI is fully committed through its R&D to improving the quality of life of patients, exporting treatments to more than 40 countries worldwide with a direct presence in Italy, Spain, France, Romania, Mexico, and Turkey.

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