FDA Clears VIA360 Surgical System for Ophthalmic Use

New World Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VIA360 Surgical System, a next-generation device designed to deliver controlled amounts of viscoelastic fluid during ophthalmic surgeries. Additionally, VIA360 is indicated for trabecular meshwork tissue excision during trabeculotomy procedures, offering enhanced precision and efficiency for surgeons.

VIA360: Advancing Surgical Precision in Ophthalmology

The VIA360 Surgical System is designed to support a variety of surgical workflows, whether used in combination with cataract surgery or as a standalone procedure.

Key Features of VIA360:

• ActiveInject Technology™: Enables on-demand viscoelastic delivery, independent of catheter movement, providing greater control for surgeons.

• Smart Prime System™: Optimizes viscoelastic volume management, ensuring efficiency throughout the procedure.

• 360-Degree Microcatheter: Designed to advance fully with micro-channels that deliver viscoelastic both forward and tangentially to targeted areas.

• Rotatable Cannula: Allows enhanced positioning and flexibility for a single-entry approach without requiring full device rotation.

Industry Experts on VIA360’s Impact

Khalid Mansour, President and COO of New World Medical, highlighted the significance of this FDA clearance:

"The clearance of VIA360 marks another milestone in our mission to deliver innovative solutions that empower surgeons and improve the lives of patients globally. This system was developed in close collaboration with ophthalmic surgeons, addressing key challenges in surgery and providing greater control, precision, and flexibility."

Surgeons Highlight VIA360’s Precision and Efficiency

Inder Paul Singh, MD, President of the Eye Centers of Racine & Kenosha, Wisconsin, emphasized the system’s benefits in real-world surgical applications:

"The VIA360 facilitates a targeted approach tailored to each patient’s individual needs. The technology elevates procedural efficiency by allowing me to deliver viscoelastic exactly where and when it’s needed, with complete control at my fingertips."

Market Launch and Availability

New World Medical has announced that the VIA360 Surgical System will be immediately available in the U.S. market, further expanding access to advanced surgical tools for ophthalmic surgeons.

With FDA clearance secured, VIA360 is set to enhance surgical precision, efficiency, and patient outcomes, reinforcing New World Medical’s commitment to innovation in ophthalmology.