The FDA has granted 510(k) clearance to New World Medical’s (NWM) VIA360 Surgical System, intended for use during ophthalmic surgeries.
First, a company refresh.
The Rancho Cucamonga, California-based ophthalmic device manufacturer provides an extensive portfolio of products, including:
- Ahmed Glaucoma Valve
- Ahmed ClearPath
- STREAMLINE Surgical System
- KDB GLIDE
- Granted FDA 501(k) expanded indication in May 2024
And what is this new product?
The VIA360 Surgical System is a delivery system for viscoelastics, also known as ophthalmic viscosurgical devices (OVDs).
- What this is: OVDs are gel-like substances utilized during eye surgery (such as cataract surgery) to maintain the shape of the eye’s anterior chamber—with properties of both a fluid and a solid.
- These are typically classified as “cohesive” or “dispersive” depending on their molecular structure and behavior during surgery.
Now talk about the VIA360.
This surgical system is designed to deliver controlled amounts of viscoelastic fluid during ophthalmic surgeries.
About this purpose: The system is also indicated to cut trabecular meshwork (TM) tissue during trabeculotomy procedures and is utilized during a number of surgical workflows, including combined with cataract surgery or in standalone procedures.
Let’s talk features.
The VIA360 is equipped with capabilities designed to give surgeons more control during surgical procedures. Included in its repertoire:
- ActiveInject Technology → Proprietary tech allowing for on-demand viscoelastic delivery (independent of catheter movement)
- Smart Prime System → Utilizes viscoelastic volume to guarantee efficiency carried throughout the procedure
Go on ...
Also unique is the design of the device’s microcatheter.
- What this enables: An advance up to 360° with “micro-channels configured to deliver viscoelastic both forward and tangentially ensuring the delivery of ophthalmic viscoelastic fluid to targeted areas," according to the company.
Plus: Its rotatable cannula allows for enhanced positioning and flexibility for a single entry—without needing a full device rotation.
Circle back to its uniqueness.
In the company announcement of the system’s clearance, Inder Paul Singh, MD, an ophthalmic surgeon and glaucoma specialist, noted VIA360’s ability to “enhance overall precision and control.”
"The VIA360 facilitates a targeted approach that is tailored to each patient's individual needs,” stated Dr. Singh, president of the Eye Centers of Racine & Kenosha in Wisconsin. “The technology elevates the efficiency of the procedure by allowing me to deliver viscoelastic exactly where and when it's needed, with complete control at my fingertips."
Sounds promising! So when will this be available for purchase?
NWM noted plans to launch the VIA360 “immediately” to the U.S. market.
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