BVI annonce l’obtention du marquage CE au titre du Règlement européen sur les dispositifs médicaux pour Virtuoso®, une toute nouvelle plateforme chirurgicale à double fonction
BVI has achieved CE marking for Virtuoso®, the first dual-function phaco-vitrectomy platform, designed to enhance surgical control and efficiency in both cataract and vitreoretinal surgeries. This milestone was marked by the successful treatment of the first patient at LMU Klinikum in Munich in December 2025. The platform has been showcased at major industry forums, including EURETINA and the Munich Retina Meeting, emphasizing its innovative fluid management and operational workflow.
The significance of Virtuoso® lies in its advanced technological features, such as Equality™ fluid control, which maintains intraocular pressure (IOP) stability throughout procedures, and Resolute™ ultrasound delivery, which optimizes energy application based on lens hardness. These innovations not only improve surgical outcomes but also streamline complex combined surgeries, addressing the evolving needs of multidisciplinary surgical centers. Early clinical data presented at various conferences indicate a robust performance, with improved energy delivery consistency and aspiration efficiency compared to leading platforms, reinforcing Virtuoso®’s competitive edge in the ophthalmic surgical market.
The introduction of Virtuoso® could shift current paradigms in surgical device development by setting new standards for integrated platforms that cater to both anterior and posterior segment procedures. As BVI prepares for a European market launch in Q3 2026, this platform may accelerate the timeline for future innovations in ophthalmic surgery, fostering a more holistic approach to patient care that aligns with the growing demand for versatile and efficient surgical solutions. The ongoing clinical study at LMU Klinikum will further validate its effectiveness, potentially influencing future design and functionality in surgical devices across the field.
Source: globenewswire.com