Dr. Norio Fukami and his workforce on the Mayo Clinic rejoice their first process with the ELS System. Supply: EndoQuest
EndoQuest Robotics Inc. mentioned a surgeon on the Mayo Clinic has efficiently accomplished a robotic process as a part of its Potential Evaluation of a Robotic Assisted Machine in Gastrointestinal Medication, or PARADIGM, Trial. The trial is a multicenter examine supposed to judge the corporate’s Endoluminal Surgical System to be used in decrease gastrointestinal observe procedures.
Dr. Norio Fukami efficiently accomplished an endoscopic submucosal dissection (ESD) utilizing the Endoluminal Surgical (ELS) System to take away a posh colorectal lesion measuring 4 cm (1.5 in.) in dimension. He’s a professor of drugs and director of Therapeutic Endoscopy and Interventional Gastrointestinal (GI) Endoscopy Fellowship at Mayo Clinic in Arizona. Fukami carried out the ESD process as a part of a U.S. Meals and Drug Administration (FDA) Investigational Machine Exemption (IDE) pivotal trial.
“The gadget was instinctive and simple to make use of, enabling dynamic traction and counter-traction of surgical approach, and made a posh process that might historically be far more difficult really feel comparatively simple,” mentioned Dr. Fukami.
“This know-how represents a monumental shift in our skill to carry out ESD and different superior endoluminal therapies,” he added. “For the primary time, we’re outfitted with a real surgeon’s ‘second hand’ that makes these procedures extra pure and reproducible, with the potential to considerably scale back sufferers’ and physicians’ burden.”
EndoQuest mentioned that Fukami is a world-renowned professional in ESD and different endoluminal and pancreaticobiliary methods. He was additionally an editor for the primary English textbook on ESD.
EndoQuest mentioned its PARADIGM surgical system provides flexibility, superior instrumentation, and an ergonomic design. | Supply: EndoQuest Robotics
EndoQuest hopes to assist sufferers keep away from invasive procedures
ESD has emerged as an efficient remedy choice for early lesions within the GI tract. It has enabled many sufferers to keep away from invasive surgical procedures comparable to colectomies, mentioned EndoQuest.
Regardless of these advantages, ESD and different superior endoluminal therapies are technically difficult with steep studying curves, the Houston firm acknowledged. That is due largely to the inherent limitations of ordinary versatile endoscopes and instrumentation, it famous.
EndoQuest mentioned it designed its system to make superior endoluminal procedures simpler to be taught and carry out. The ELS System permits surgical duties and maneuvers not presently doable in superior therapeutic endoscopy, the corporate asserted.
Pre-clinical information introduced by Brigham and Ladies’s Hospital at Digestive Illness Week (DDW) in 2024 and 2025 demonstrated that the ELS System considerably reduces the training curve in comparison with typical methods for ESD and full-thickness defect closure amongst novice gastroenterologists.
“Therapeutic endoscopy represents one of many fastest-growing areas inside medication,” said Dr. Todd Wilson, chief medical officer and chairman of the Worldwide Advisory Board of EndoQuest Robotics. “With a larger than 50% enhance within the variety of superior endoscopy fellowship packages over the previous decade, there’s clearly a rising curiosity in advancing endoluminal, organ-sparing care, and our know-how is positioned to drive this therapeutic shift.”
PARADIGM Trial to proceed throughout the U.S.
The PARADIGM Trial is enrolling 50 topics throughout 5 main U.S. healthcare establishments: Brigham and Ladies’s Hospital in Boston; Mayo Clinic in Scottsdale, Ariz.; Cleveland Clinic in Cleveland; AdventHealth in Orlando, Fla.; and HCA Healthcare in Houston. Following trial completion, EndoQuest Robotics plans to submit a De Novo request for authorization to market the ELS System within the U.S.
In July, EndoQuest closed a Collection D-2 funding spherical. The firm mentioned the funding will gasoline the development of its versatile endoluminal surgical platform, supporting the PARADIGM medical trial.
EndoQuest mentioned its ELS System is an investigational gadget, has not but been totally cleared by the FDA, and isn’t but obtainable for business sale within the U.S.
Editor’s observe: Iman Jeddi, senior vice chairman and basic supervisor at Intuitive Surgical, will ship a keynote at RoboBusiness 2025, which will likely be on Oct. 15 and 16 in Santa Clara, Calif. She is going to focus on the design and launch of the da Vinci 5 surgical robotic.
RoboBusiness will likely be co-located with DeviceTalks West, the premier trade occasion for medical know-how professionals. Register now to attend.
