FDA Grants IDE for Clinical Study of Flexible Robotic System

EndoQuest Robotics Inc. has gained U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) to study its Endoluminal Surgical (ELS) System.

“Prospective Assessment of a Robotic-Assisted Device in Gastrointestinal Medicine (PARADIGM)” is a multi-center, open-label, prospective study to evaluate EndoQuest’s Endoluminal Surgical System’s safety and performance in robotic endoscopic submucosal dissection (ESD) procedures for removing colorectal lesions. Fifty subjects will participate across five U.S. healthcare institutions, including Brigham and Women’s Hospital (Boston), Mayo Clinic (Scottsdale, Ariz.), Cleveland Clinic (Cleveland), AdventHealth (Orlando, Fla.), and HCA Healthcare (Houston, Texas).

“This IDE approval marks a significant milestone in EndoQuest’s mission to revolutionize minimally invasive surgery,” EndoQuest Robotics Interim CEO Eduardo Fonseca said. “Our flexible robotic technology has the potential to transform colorectal surgical outcomes, empowering physicians with 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.”

The ELS System aims 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 last year demonstrated the ELS System had superior procedural outcomes, a shorter learning curve, and reduced procedure time versus the conventional technique.

“We’re thrilled to have received approval from the FDA to start our clinical trial,” EndoQuest Robotics Chief Medical Officer/Scientific Advisory Boar Chairman Dr. Todd Wilson state. “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.”

EndoQuest Robotics develops endoluminal robotic technologies. The company strives to address unmet needs in gastrointestinal (GI) medicine and endoluminal surgery by enabling physicians with unprecedented surgical access, precision, and flexibility. The company’s proprietary technology is designed to navigate and perform scar-free procedures through the body’s natural orifices, allowing for the least invasive surgical approach. Since EndoQuest Robotics was founded, the company has collaborated extensively with healthcare providers, researchers, and industry partners to advance the development of its flexible robotic system with the goal of improving patient outcomes and redefining a new standard in minimally invasive surgery.

EndoQuest’s Flexible Robotic System is under development, has not been cleared by the FDA, and is not yet available for commercial sale in the United States.