Two innovative surgical robotics companies have reached significant clinical milestones, with both EndoQuest Robotics and Virtuoso Surgical announcing the commencement of human trials for their respective minimally invasive robotic systems.
EndoQuest Begins Pivotal Trial for Endoluminal Robotic System
Houston-based EndoQuest Robotics has successfully completed the first procedures in its pivotal trial at HCA Houston Healthcare Medical Center. The company's endoluminal robotic surgery system is designed to navigate through natural body openings, potentially reducing the need for external incisions.
The trial follows the FDA's grant of an investigational device exemption (IDE) in December, allowing EndoQuest to study its system in procedures to remove colorectal lesions. The first two procedures in the Paradigm study involved endoscopic submucosal dissection (ESD) of complex lesions in the rectum and sigmoid colon.
ESD is a technically challenging procedure that removes lesions under the lining of the gastrointestinal tract. Despite its benefits as a minimally invasive approach, the technique has seen limited adoption in the United States due to its difficulty.
"Our robotic system is intended to address the technical challenges associated with ESD, potentially allowing more physicians to adopt this technique instead of more invasive procedures such as colectomies," said Todd Wilson, Chief Medical Officer at EndoQuest.
The Paradigm study will enroll 50 patients across five prestigious U.S. medical centers: Brigham and Women's Hospital in Boston, Mayo Clinic in Scottsdale, Cleveland Clinic, AdventHealth in Orlando, and HCA Houston. Upon completion of the trial, EndoQuest plans to submit a de novo request to the FDA for marketing authorization.
Virtuoso Surgical Completes First-in-Human Bladder Cancer Procedures
In a parallel development, Nashville-based Virtuoso Surgical has announced the successful completion of its first human cases using the Virtuoso robotic endoscopy system. The system was used to perform bladder lesion excisions in six patients during the pilot phase of the Viable trial at The Chinese University of Hong Kong.
The Virtuoso system features two robotically controlled, needle-sized (less than 1mm) manipulators that operate from the tip of a rigid endoscope. This innovative design enabled surgeons to perform en bloc resections of bladder tumors—a technique that removes lesions intact rather than piecemeal.
Dr. Jeremy Teoh, a world-renowned bladder cancer surgeon who performed the procedures, highlighted the significance of the technology: "The ability to perform an en bloc resection for bladder cancer with this level of robotic assistance is a game-changer even for an expert in the technique. The Virtuoso system offered exceptional maneuverability, dexterity, and visual clarity, enabling meticulous dissection."
The en bloc technique has been shown to offer significant advantages for bladder cancer patients, including reduced risk of tumor cell spillage and potentially lower recurrence rates. A recent randomized controlled trial published in European Urology demonstrated a decreased risk of cancer recurrence at one year with the manual en bloc technique.
Despite these benefits, en bloc procedures are not commonly performed in the U.S., likely due to the dexterity limitations of current equipment. The Virtuoso system aims to overcome these challenges through its advanced instrumentation and multiple-arm dexterity.
Technological Innovations and Future Applications
The Virtuoso system's technology is based on patented concentric tube robotic arm technology, originally conceived by Vanderbilt University professor Robert J. Webster III, Ph.D., who is also the founder and President of Virtuoso Surgical.
"Our vision at Virtuoso Surgical is to give surgeons unprecedented dexterity. This will enable them to perform less invasive, more accurate surgeries that improve patients' lives and long-term health outcomes," said Dr. Webster.
Dr. S. Duke Herrell, CEO of Virtuoso Surgical and a urologic surgeon, emphasized the unique positioning of their technology: "We are unlike any surgical robot out there today. The Virtuoso system is designed for a different set of procedures and approaches that have not yet benefited from robotics. This is a new type of robot, significantly smaller in scale, which enables us to bring our surgical skills deep into the body with less invasiveness for the patient."
Virtuoso Surgical has already conducted early feasibility studies in uterine fibroids, pulmonary procedures, and neurosurgery, and is exploring applications in endoscopic spine procedures. The company plans to submit an IDE application to the FDA for studies in the United States.
Implications for Minimally Invasive Surgery
Both EndoQuest and Virtuoso represent a new generation of surgical robotics focused on enabling minimally invasive procedures in areas that have traditionally required more invasive approaches. By addressing the technical challenges that have limited the adoption of advanced endoscopic techniques, these systems could potentially expand the range of procedures that can be performed with minimal disruption to patients.
The successful initiation of human trials for both systems marks an important step forward in the evolution of surgical robotics, with potential benefits for patient recovery times, complication rates, and overall outcomes. As these trials progress, they will provide valuable data on the safety and efficacy of these innovative approaches to minimally invasive surgery.
