510(k) clearance issued by FDA for the VIA360 Surgical System by New World Medical

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New World Medical received 510(k) clearance from the US Food and Drug Administration (FDA) for its VIA360 Surgical System for the delivery of controlled amounts of viscoelas­tic fluid during ophthalmic surgeries. The company plans on launching VIA360 immediately in the US market.

According to the press release issued by the company, the VIA360 is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures and supports a variety of surgical workflows, whether combined with cataract surgery or in standalone procedures.

Surgeon Control

In sharing this clearance, New World Medical noted that the VIA360 Surgical System is designed with intuitive features to optimize surgeon control. Among these features is the proprietary ActiveInject Technology, which enables on-demand viscoelastic delivery independent of catheter movement, and the Smart Prime System optimizes viscoelastic volume, which ensures efficiency throughout the procedure.

VIA36™ Surgical System - Image courtesy New World Medical

The device’s microcatheter is designed to advance up to 360 degrees with micro-channels configured to deliver viscoelastic both forward and tangentially, ensuring the delivery of ophthalmic viscoelastic fluid to targeted areas. The technology's rotatable cannula provides enhanced positioning and flexibility for a single entry without requiring full device rotation.

Inder Paul Singh, MD, President of the Eye Centers of Racine & Kenosha, Racine and Kenosha, Wisconsin, explains the value of the VIA360 Surgical System is in its capacity to enhance overall precision and control, saying, "The VIA360™ facilitates a targeted approach that is tailored to each patient's individual needs. 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.”

Reference

1. New World Medical Receives 510(k) Clearance for the VIA360(TM) Surgical System, Further Advancing Innovation in Ophthalmic Surgery. New World Medical. February 18, 2025. Accessed February 18, 2025. /www.newswire.com/news/new-world-medical-receives-510-k-clearance-for-the-via360-tm-surgical-22523447