An innovative glaucoma surgical system – the Leos (Laser Endoscopy Ophthalmic System) developed by BVI Medical – has received 510(k) clearance from the United States Food and Drug Administration.
According to BVI Medical, Leos is the only laser system that lowers intraocular pressure by addressing aqueous humor production in a minimally invasive ab interno procedure. It incorporates unique endoscopic capabilities to provide visualisation of the eye anatomy in a way not seen with the latest imaging systems.
Leos is supported by emerging data from a randomised controlled clinical trial, further validating its safety and efficacy.
“The development of Leos was driven by a deep understanding of the challenges clinicians face in managing glaucoma, such as visualisation and access to target tissue,” said Mikhail Boukhny, Vice President, Global Research and Development.
Our goal was to create a system that… enhances the surgical experience through improved intuitiveness, precision, and ease of use
“Our goal was to create a system that not only offers a novel and effective treatment approach but also enhances the surgical experience through improved intuitiveness, precision, and ease of use. This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their patients.”
Glaucoma affects more than 76 million people globally, with projections reaching 111.8 million by 2040.1
Reference
- BVI Medical announces approval of breakthrough technology: FDA 510(k) clearance of its laser endoscopy ophthalmic system: Leos. Available at bvimedical.com/bvi-medical-announces-approval-of-breakthrough-technology-fda-510k-clearance-of-its-laser-endoscopy-ophthalmic-system-leos [accessed April 2025].
