New World Medical has 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 VIA360, which is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures,¹ supports a variety of surgical workflows, whether combined with cataract surgery or in standalone procedures, the company said in a press release. 

According to New World Medical, the VIA360 Surgical System's proprietary ActiveInject Technology enables on-demand viscoelastic delivery independent of catheter movement, and its Smart Prime System optimizes viscoelastic volume ensuring efficiency throughout the procedure.² The device's microcatheter is designed to 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. In addition, the technology's rotatable cannula provides enhanced positioning and flexibility for a single entry without requiring full device rotation.

Ophthalmic surgeon and glaucoma specialist Inder Paul Singh, MD, explained in the press release that the ultimate value of the VIA360 Surgical System lies in its capacity to enhance overall precision and control. "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," said Dr. Singh, president of the Eye Centers of Racine & Kenosha.

The company plans on launching the VIA360 Surgical System immediately in the US market.

References:

1. FDA 510(k) Clearance K243503
2. Data on file, New World Medical, January, 2025