EndoQuest Robotics granted FDA approval for robotic colorectal surgery study

The US Food and Drug Administration (FDA) has granted EndoQuest Robotics, a privately-held pioneer in the development of flexible endoluminal robotic technologies, an Investigational Device Exemption (IDE) for its pivotal colorectal clinical study, Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM).

This landmark multi-center, open-label, prospective study will evaluate EndoQuest’s state-of-the-art Endoluminal Surgical (ELS) System’s safety and performance in robotic endoscopic submucosal dissection (ESD) procedures for the removal of colorectal lesions.

Fifty subjects will participate across five leading US healthcare institutions, including Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), AdventHealth (Orlando), and HCA Healthcare (Houston).

Eduardo Fonseca, interim CEO of EndoQuest Robotics, says: “This IDE approval marks a significant milestone in EndoQuest’s mission to revolutionize minimally invasive surgery.

“Our flexible robotic technology has the potential to transform colorectal surgical outcomes, empowering physicians with innovative tools to deliver less invasive, scar-free procedures. We’re excited to proceed to human cases and move one step closer to initiating the next paradigm of surgery.”

Dr Todd Wilson, chief medical officer and chairman of the scientific advisory board of EndoQuest Robotics, says: “We’re thrilled to have received approval from the FDA to start our clinical trial.

“This technology represents the evolution we have been waiting for to finally perform endoluminal surgery, which could redefine what’s possible in minimally invasive colorectal procedures and potentially allow a significant number of patients to avoid invasive operations like colectomies.”

The ELS System is designed to solve the technical challenges and decrease the learning curve associated with complex endoluminal procedures such as ESD.

The ELS System enables endoluminal procedures with the visualization, precision, and main tenets of conventional surgical technique, allowing for surgical tasks and maneuvers not currently possible in advanced endoscopy.

A pre-clinical ESD study presented at Digestive Disease Week (DDW2024) in 2024 demonstrated that the ELS System had superior procedural outcomes, a shorter learning curve, and reduced procedure time versus the conventional technique.