Momentis Surgical has announced that it has received FDA 510(k) clearance for its second-generation Anovo robotic surgical platform. This clearance marks a significant advancement in robotic-assisted surgery, building upon the initial FDA De Novo marketing authorization for the use of Anovo in single-site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures, including benign hysterectomy.
The second-generation Anovo platform incorporates several upgrades designed to enhance the surgeon's experience and improve ease of use. A key feature is the integration of haptic feedback, providing surgeons with more intuitive control of the robotic arms during procedures. The platform is also the first FDA-cleared robotic system capable of operating in both retroflexion and anteflexion, delivering enhanced reach and articulation from a single incision. Additionally, a new annotation-enabled video overlay facilitates in-room communication and supports teaching and collaboration among medical teams.
Enhanced Surgical Capabilities
The updated Anovo system introduces dual-mode articulation, allowing surgeons to operate with greater precision and flexibility. Ricardo E. Estape, MD, a gynecology oncologist at Kendall Regional Medical Center, noted that the new controllers, haptic feedback, and floor-mounted pedestal make the system extremely easy to use, unlocking the robot's capabilities.
Expansion of Surgical Applications
Momentis Surgical aims to expand the applications of the Anovo platform beyond gynecology. Michael Conditt, PhD, SVP of Strategic Marketing and Clinical Development at Momentis Surgical, indicated that the small size and ease of use of the Anovo platform make it ideal for more surgeons to offer robotic surgery solutions at sites of care beyond the hospital setting, like outpatient Ambulatory Surgery Centers. The company is pursuing further indication expansions into bariatric, colorectal, and ENT surgeries.
Global Expansion Plans
Following the FDA clearance, Momentis Surgical plans to broaden its global presence. Dvir Cohen, CEO of Momentis Surgical, stated that the company is building strong momentum following the impressive clinical outcomes achieved in gynecology. The focus is now on expanding Anovo's applications to additional indications, including general surgery, and introducing Anovo to markets in Europe and Asia in the future.
About the Anovo System
The Anovo system features miniature humanoid-shaped robotic arms that provide human-level dexterity, multi-planar flexibility, and 360 degrees of articulation. Momentis Surgical aims to transform the field of robotic surgery by developing innovative, small-footprint, cost-effective robotic-assisted technologies and techniques for a growing number of clinical applications.
