FDA Clears New World Medical's VIA360 Surgical System
New World Medical has received 510(k) clearance from the 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, according to New World Medical.
“The clearance of VIA360 marks another milestone in our mission to deliver innovative solutions that empower surgeons and improve the lives of patients globally," Khalid Mansour, President and COO of New World Medical, said in a company news release. "This system was developed in close collaboration with ophthalmic surgeons, addressing key challenges in surgery and providing greater control, precision, and flexibility."
The VIA360 Surgical System is designed with features to optimize surgeon control. Its 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 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.
“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 Inder Paul Singh, MD, who is President of the Eye Centers of Racine & Kenosha, Racine and Kenosha, Wisconsin.
New World Medical plans on launching VIA360 immediately in the US market.
References:
- FDA 510(k) Clearance K243503
- Data on file, New World Medical, January, 2025