Momentis Surgical’s Anovo robotic surgical platform has secured 510(k) clearance from the US FDA for use in single-site, abdominal access ventral hernia repair.
The device features humanoid robotic arms, which the company says are designed to provide human-level dexterity. The arms are controlled by a surgeon from the Anovo console, which allows them to replicate the motions and capabilities of a surgeon’s arms, shoulders, elbows and wrist joints.
Momentis’ CEO Dvir Cohen told Medical Device Network that the novel surgical instrument system mimics the human shoulder, elbow and wrist, allowing for 360-degree rotation and flexion through a single small incision.
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Cohen explained that this technology is a significant improvement over traditional laparoscopic and robotic surgical tools, where the straight sticks could cause trauma to healthy tissue during the procedure: “40 years ago, if a surgeon wanted to do any surgical procedures, he would need to cut the abdomen open from side to side to get access into the organs to provide the surgical tasks. Then, 30 years ago, straight sticks tools and traditional robotics came about to reduce the invasiveness. And we’re introducing a surgical robot with flexible arms,” explained Cohen.
He added that the Anovo system offers benefits over standard surgical methods, including less invasive and less traumatic access and the ability to perform procedures in ambulatory surgery centres due to the system’s mobility, small footprint and lower cost.
The clearance was supported by data from a multi-centre, prospective study (NCT06457971) that enrolled 30 subjects undergoing ventral hernia repair. The study included an in-clinic visit two weeks following the procedure, and one telephone follow-up, four weeks after the surgery. The primary endpoint was successfully met as there were no instances of conversion to open surgery or to laparoscopy approach during the surgeries for all 30 subjects enrolled.
This FDA clearance expands on Momentis’ existing approvals in natural orifice laparoscopic-assisted transvaginal benign gynaecology surgical procedures. This includes benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries).
Momentis now plans to expand the use of its platform technology to additional indications past gynaecology and general surgery, with the goal of promoting better patient and economic outcomes.
“This FDA approval is very significant as it positions us as a platform technology company. Not only in the field of gynaecology, but also for the general surgery market, and we plan to expand to more indications to promote better patient outcomes,” said Cohen.
“This is just the beginning. This is a very disruptive technology,” he concluded.
According to GlobalData, the surgical robotics market was worth $10bn in 2023, as is projected to reach $15.8bn by 2030. Several factors are playing a role in the growth of the robotic surgery market, such as the increasing demand from the growing elderly population seeking less-invasive and precise surgical options, and the emphasis on value-based healthcare that aims to enhance surgical outcomes, according to GlobalData medical analyst Graysen Vigneux.
