Robotic spine surgery system
Approved in the US
eCential Robotics, a company specialising in surgical robotics, has developed a spine surgery platform that provides intra-operative 2D and 3D imaging, navigation and robotic guidance for performing surgical procedures.
The company received 510(k) clearance for the platform’s imaging system from the US Food and Drug Administration (FDA) in 2021, while the platform’s surgical arm was granted 510(k) clearance in September 2022.
The FDA approval enables eCential Robotics to introduce the unified robotic platform in the US and gain access to the North American market over the coming years.
The robotic platform is designed to be used in spine surgery, but will eventually be upgraded for use in many other procedures.
Design and features of eCential Robotics’ spine surgery platform
eCential Robotics’ spine surgery system is an integrated, open platform that combines intraoperative 2D/3D imaging, navigation and robotics in its core design while offering stereotaxic guidance.
The system comprises three movable, interconnected parts. These are a mobile X-ray C-arm imaging system or Surgivisio Platform, a mobile viewing workstation, and a mobile collaborative robot (CoBot) with a surgical arm. The system features a single user interface that enables all the components and functions, including imaging, navigation and robotics, to be controlled from a single input and output graphical display screen.
The Surgivisio Platform is a mobile X-ray C-arm system comprising a five-axis imaging robot. It can perform image reconstruction and real-time navigation of anatomical structures and objects with excellent contrast in both 2D and 3D.
The Surgivisio Platform is designated as a CE-marked class IIb medical device in Europe.
The platform can be used for emergency, routine or complex procedures without the need for any pre-operation imaging. It can also be used as a conventional 2D-arm for applications such as visualising cement injection in real-time.
The platform’s navigation feature includes robotic guidance and freehand navigation based on standard and established navigational techniques that deploy 3D optical position tracking technology.
In addition, the Surgivisio Platform is equipped with a stereoscopic camera, a computer platform, navigation software, and a robotic C-arm. It also includes instruments with marker spheres to enable surgeons to make precise localisation in the anatomy.
Benefits of eCential Robotics’ spine surgery platform
The spine surgery system uses patented technologies for robotics, navigation, and imaging that provide surgeons with consistent precision throughout a surgical procedure. It is designed to improve the accuracy and safety of spine surgery while facilitating ease of use.
The system enables less invasive procedures while allowing surgeons to work in a reliable and uncomplicated environment, providing improved benefit for patients. It is a fully open solution that allows the use of implants from any manufacturer.
In addition, the system improves the surgical workflow by automating several technical steps, while addressing the drawbacks of conventional image-navigation pairing such as faulty calibration and registration steps.
eCential Robotics is currently working on developing applications that will be dedicated to a particular indication. This will further optimise workflows, enabling surgeons to perform surgeries safely and precisely.
Marketing commentary on eCential Robotics
eCential Robotics is a surgical robotics company based in Grenoble, France, that currently holds 80 patents and seven trademarks. It develops and distributes a revolutionary technology that combines real-time navigation and 2D/3D robotic imaging.
The company designs and manufactures all its equipment, including hardware and software. It was the winner of the Bpifrance Worldwide Innovation Challenge in 2018.
In December 2021, eCential received €15m ($16.9m) from the European Investment Bank (EIB) to fund the research and development of a comprehensive robotic solution that will help surgeons perform less invasive surgeries.