EndoQuest Robotics recently announced the completion of the first procedure performed by a gastroenterologist in its PARADIGM trial.
PARADIGM, a pivotal multicenter study, evaluates the company’s Endoluminal Surgical (ELS) system. It looks at ELS in lower gastrointestinal (GI) tract procedures by both colorectal surgeons and gastroenterologists.
In May, the company announced the first colorectal cases in the trial. The latest procedures mark the world’s first fully robotic endoscopic submucosal dissection (ESD) performed by a gastroenterologist in an FDA investigational device exemption (IDE) pivotal trial. The FDA granted the IDE for the study last December.
Dr. Norio Fukami of Mayo Clinic, Arizona, completed the robotic ESD using the EndoQuest ELS system. Fukami removed a complex colorectal lesion measuring 4 cm in size. In a news release, Fukami said the robot delivers “a true surgeon’s ‘second hand.'” This makes procedures more natural and reproducible, potentially reducing patient and physician burden.
“The device was instinctive and easy to use, enabling dynamic traction and counter-traction of surgical technique, and made a complex procedure that would traditionally be much more challenging feel relatively straightforward,” said Fukami. “This technology represents a monumental shift in our ability to perform ESD and other advanced endoluminal therapies.”
More about the EndoQuest robot and the PARADIGM trial
EndoQuest designed its surgical robot platform to address unmet needs in GI and other endoluminal surgeries. The system can deliver precision and flexibility to improve patient outcomes. The company says it enables endoluminal procedures with the visualization, precision and main tenets of conventional surgical techniques. It allows for surgical tasks and maneuvers not currently possible in advanced therapeutic endoscopy.
The proprietary technology navigates and performs procedures within the body’s lumina spaces, allowing for minimally invasive interventions. It makes it possible for therapeutic endoscopists and surgeons to operate through a trans-oral or trans-anal approach. EndoQuest raised $42 million to support the platform a year ago.
Pre-clinical data previously demonstrated a reduced learning curve and full-thickness defect closure with the EndoQuest system. Now, the PARADIGM trial aims to support the company’s FDA de novo submission, slated for after the trial’s completion. EndoQuest expects to enroll 50 subjects across five leading U.S. healthcare institutions.
“Our passionate team is committed to transforming patient care by empowering a broad spectrum of physicians and procedures with the benefits of robotics,” said Eduardo Fonseca, CEO of EndoQuest Robotics. “EndoQuest is positioned to accelerate adoption of robotics beyond the operating room and into endoscopy suites and ambulatory surgery centers, unlocking significant clinical and commercial value well beyond our initial focus on ESD.”
