BVI Medical Receives FDA 510(k) Clearance for Leos Glaucoma Surgical System

BVI Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative glaucoma surgical platform, the Laser Endoscopy Ophthalmic System (Leos). The system is expected to become commercially available in the United States in the coming months.

Introducing Leos: A Novel Laser ECP System for Glaucoma

Leos is designed to deliver a minimally invasive ab interno endoscopic cyclophotocoagulation (ECP) procedure. It is currently the only laser system that reduces intraocular pressure (IOP) by targeting aqueous humor production, combining treatment precision with improved safety.

The system’s advanced endoscopic capabilities provide enhanced visualization of intraocular anatomy, allowing surgeons to better access and treat targeted structures. It is engineered to integrate seamlessly into the existing surgical workflow while enhancing ease of use and procedural intuitiveness.

Clinical Validation and Emerging Data

The clearance of Leos is supported by emerging clinical data from a randomized controlled trial, which further confirms the safety and efficacy of the system in glaucoma management. These findings provide additional confidence in its role as a next-generation tool for ophthalmic surgeons.

Executive Commentary on FDA Clearance

In the company’s official announcement, Shervin Korangy, President and CEO of BVI Medical, emphasized the significance of this milestone:

“This momentous milestone underscores our commitment to innovation. We have been building a strong pipeline that is starting to play out in numerous geographies across the world, including Leos in the US market.”

Mikhail Boukhny, Vice President of Global R&D, added:

“The development of Leos was driven by a deep understanding of the challenges clinicians face in managing glaucoma, such as visualization and access to target tissue. 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.”

Upcoming U.S. Launch

With regulatory approval secured, BVI Medical plans to launch Leos in the U.S. market in the near future, expanding access to a cutting-edge, minimally invasive glaucoma treatment option.