Mayo Clinic Breaks Ground In Robotic Surgery With First-Ever Esd Procedure

Mayo Clinic Breaks Ground In Robotic Surgery With First-Ever Esd Procedure

The cutting-edge world of robotic surgery has taken a significant leap forward with the completion of the first-ever robotic endoscopic submucosal dissection (ESD) procedure at the renowned Mayo Clinic. EndoQuest Robotics Inc., a leading innovator in flexible endoluminal surgical platforms, has successfully partnered with Dr. Norio Fukami, a world-renowned expert in ESD and other advanced gastrointestinal techniques.

On [Date], Dr. Fukami performed an ESD using the Endoluminal Surgical (ELS) System to remove a complex colorectal lesion measuring 4 cm (1.5 in.) in size. This groundbreaking procedure marked a significant milestone in the company’s Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine (PARADIGM) Trial, a multicenter study designed to evaluate the efficacy and safety of the ELS System.

The PARADIGM Trial is a pivotal trial that aims to assess the effectiveness of the ELS System in lower gastrointestinal tract procedures. The trial involves 50 subjects across five leading U.S. healthcare institutions, including Brigham and Women’s Hospital, Mayo Clinic, Cleveland Clinic, AdventHealth, and HCA Healthcare. By enrolling patients with diverse clinical profiles, the study seeks to provide comprehensive insights into the safety and efficacy of the ELS System.

The success of this robotic procedure is a testament to EndoQuest Robotics’ cutting-edge technology and Dr. Fukami’s expertise in advanced gastrointestinal techniques. The company’s innovative approach aims to make complex procedures more accessible and easier to learn for novice gastroenterologists.

Fukami stated, “The device was instinctive and easy to use, enabling dynamic traction and counter-traction of surgical technique.” This remark underscores the significant potential of the ELS System in revolutionizing gastrointestinal care.

ESD has emerged as a highly effective treatment option for early lesions in the GI tract, offering patients a less invasive alternative to traditional surgeries like colectomies. However, despite these benefits, ESD and other advanced endoluminal therapies are technically challenging, requiring significant expertise and training.

EndoQuest Robotics recognized this challenge and designed its system to address it. The ELS System is engineered to facilitate learning and improve the overall surgical experience for both novice and experienced gastroenterologists. Pre-clinical data presented at Digestive Disease Week (DDW) in 2024 and 2025 demonstrated that the ELS System significantly reduces the learning curve compared to conventional techniques for ESD and full-thickness defect closure.

The therapeutic endoscopy represents one of the fastest-growing areas within medicine, with a greater than 50% increase in the number of advanced endoscopy fellowship programs over the past decade. There is clearly a growing interest in advancing endoluminal, organ-sparing care, and EndoQuest Robotics’ technology is positioned to drive this therapeutic shift.

The PARADIGM Trial will continue across the U.S., with plans to enroll patients at multiple sites. Following trial completion, EndoQuest Robotics aims to submit a De Novo request for authorization to market the ELS System in the U.S. The company’s commitment to innovation and research is evident in its efforts to bring groundbreaking technologies like the ELS System to market.

In July 2024, EndoQuest closed a Series D-2 funding round, which will fuel the advancement of its flexible endoluminal surgical platform, supporting the PARADIGM clinical trial. With this investment, the company will continue to push the boundaries of robotic surgery and expand its reach in the medical community.

The completion of the first robotic ESD procedure at Mayo Clinic marks a significant milestone in the development of EndoQuest Robotics’ cutting-edge technology. As the field of robotic surgery continues to evolve, innovations like the ELS System are poised to transform the way we approach complex gastrointestinal procedures, offering patients improved outcomes and reduced recovery times.

With its commitment to advancing endoluminal care and addressing the challenges associated with traditional techniques, EndoQuest Robotics is well-positioned to drive a shift towards more advanced, organ-sparing therapies.

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