New World Medical, a leading innovator in ophthalmic surgical devices, is proud to announce that it 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.
"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," says Khalid Mansour, president and COO of New World Medical.
Enhanced surgeon control
The VIA360 Surgical System is thoughtfully designed with intuitive 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 uniquely 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.
Targeted viscoelastic delivery
Ophthalmic surgeon and glaucoma specialist Inder Paul Singh, MD, explains 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" says Dr. Singh, who is President of the Eye Centers of Racine & Kenosha, Racine and Kenosha, Wisconsin.
US market launch
The FDA's 510(k) clearance of VIA360 Surgical System underscores New World Medical's commitment to driving innovation and excellence in ophthalmic surgery.
The company remains dedicated to advancing ophthalmic surgery through cutting-edge technologies and meaningful collaborations with ophthalmic surgeons worldwide. The company plans on launching VIA360 immediately in the US market.
References
FDA 510(k) Clearance K243503
Data on file, New World Medical, January, 2025